Weight LossPhase 2/3Opt-INNCT01814072

Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity

A Phase 2/3 study testing 12 Telephone Coaching Sessions, 24 Telephone Coaching Sessions and Report to Primary Care Physician in people with Weight Loss, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Weight Loss
What is being tested?: 12 Telephone Coaching Sessions, 24 Telephone Coaching Sessions and Report to Primary Care Physician
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 562 participants
Where: 1 siteUnited States
Study dates: Sep 2013to 20 Sep 2017
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

18 and 60 years old
BMI 25-40 kg/m2
Weight stable (no loss or gain >25 lbs for the past 6 months)
Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
Own a Smartphone and be willing to install the Opt-IN app
Able to use the app to record dietary intake and weight onto the Smartphone

Show all 11Show fewer

"Buddy" participants must:
18 years of age or older
Have access to a computer and internet
Be willing to undergo "Buddy Training" and participate in 4 webinars
Be willing to provide support and encouragement to the participant

Who cannot join

Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
Use an assistive device for mobility (e.g., wheelchair, walker, cane)
Plantar fasciitis
Hospitalization for a psychiatric disorder within the past 5 years
At risk for adverse cardiovascular (CVD) events with moderate intensity activity

Show all 12Show fewer

Cannot read the study questionnaires
Committed to following an incompatible dietary regimen
Not be pregnant, trying to get pregnant, or lactating
Bulimia, binge eating disorder, current substance abuse or dependence (besides nicotine dependence) or report active suicidal ideation
Low motivation to change
Cannot live with a current or past Opt-IN participant

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

The overall objective of the proposed research is to use an innovative methodological framework, the Multiphase Optimization Strategy (MOST), to design, for the first time, an optimized, scalable version of a technology-supported intensive lifestyle intervention (INLI) for obesity. MOST involves highly efficient randomized experimentation to assess the effects of individual treatment components, and thereby identify which components and component levels make important contributions to the overall program effect on weight loss. This information then guides assembly of an optimized treatment package that achieves target outcomes with least resource consumption and participant burden. Because the intervention strategies being tested minimize in-person coaching and leverage technology that participants already own, the new optimized intervention, to be called Opt-IN, will be more scalable than traditional INLIs. Opt-IN will thus enjoy greatly increased reach, and enable significant progress in the fight against obesity.

Read the detailed description

The goal of the proposed study is to determine the optimal composition of a technology supported intervention for obesity that minimizes expense and burden to participants, while achieving 6 month weight loss outcomes comparable or superior to those achieved by the current full cost, full burden form of INLIs. All intervention components to be examined were selected based on the Opt-IN model's prediction that they enhance behavioral adherence to weight regulation via the designated pathways. The five components to be tested will be: (1) coaching intensity (12 vs. 24 phone sessions), (2) text messaging (No vs. Yes), (3) progress report to participant's primary care provider (No vs. Yes), (4) recommendation to use meal replacements (No vs. Yes), (5) training participants' self-selected buddies to be supportive (No vs. Yes).

Conditions: Weight Loss
Being tested: 12 Telephone Coaching Sessions, 24 Telephone Coaching Sessions, Report to Primary Care Physician, Text Messages, Recommendations to use meal replacements
Medical subject headings: Weight Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

12 Telephone Coaching SessionsBehavioural
Participants will receive 12 telephone coaching sessions
24 Telephone Coaching SessionsBehavioural
Participants will receive 24 telephone coaching sessions
Report to Primary Care PhysicianBehavioural
Participants will have a report detailing their weight loss progress sent to their primary care physician
Text MessagesBehavioural
Participants will receive regular text messages
Recommendations to use meal replacementsBehavioural
Participants will receive recommendations from their coach to use meal replacements
Buddy TrainingBehavioural
Participants will have a buddy that will be trained via webinars to be a supportive buddy

Study groups in NCT01814072
Study group	Role	What they receive
Condition 1	Experimental	1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician
Condition 2	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training
Condition 3	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Buddy Training
Condition 4	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements
Condition 5	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Buddy Training
Condition 6	Experimental	1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements
Condition 7	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages
Condition 8	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training
Condition 9	Experimental	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician
Condition 10	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training
Condition 11	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Buddy Training
Condition 12	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements
Condition 13	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Buddy Training
Condition 14	Experimental	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements
Condition 15	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages
Condition 16	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training
Condition 17	Experimental	1) Lifestyle Core; 2) 12 Telephone Coaching Sessions Receives: Behavioral: 12 Telephone Coaching Sessions
Condition 18	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training
Condition 19	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Buddy Training
Condition 20	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements
Condition 21	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars Receives: Behavioral: Report to Primary Care Physician; Behavioral: Buddy Training
Condition 22	Experimental	1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements Receives: Behavioral: Report to Primary Care Physician
Condition 23	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages
Condition 24	Experimental	1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars Receives: Behavioral: 12 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training
Condition 25	Experimental	1) Lifestyle Core; 2) 24 telephone coaching sessions Receives: Behavioral: 24 Telephone Coaching Sessions
Condition 26	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training
Condition 27	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Buddy Training
Condition 28	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements
Condition 29	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Buddy Training
Condition 30	Experimental	1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Recommendations to use meal replacements
Condition 31	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages
Condition 32	Experimental	1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars Receives: Behavioral: 24 Telephone Coaching Sessions; Behavioral: Report to Primary Care Physician; Behavioral: Text Messages; Behavioral: Recommendations to use meal replacements; Behavioral: Buddy Training

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight Change (kg) From Baseline to Month 6, Main Effect of Time
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Measured: From Baseline to Month 6
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).
Measured: From Baseline to Month 6

Secondary outcomes (1)

Intervention for <$500
Using the results from primary aim 1, an intervention with only active treatment components with the largest treatment effect that can be obtained for implementation costs of $500 or less was identified and built.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 201320 Sep 2017

First posted19 Mar 2013 (estimated)
Study startSep 2013
Primary completion20 Sep 2017
Study completion20 Sep 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (33)Papers the sponsor has linked to this study.
Other trials for Weight LossStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 562 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01814072
Sponsor's protocol ID: NIH NIDDK R01DK097364-01
Other IDs: R01DK097364-01
Acronym: Opt-IN
Status last verified: Jan 2023
First submitted: 15 Mar 2013
Last updated: 1 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
PubMed 17466815
Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
PubMed 27663578
Baker TB, Smith SS, Bolt DM, Loh WY, Mermelstein R, Fiore MC, Piper ME, Collins LM. Implementing Clinical Research Using Factorial Designs: A Primer. Behav Ther. 2017 Jul;48(4):567-580. doi: 10.1016/j.beth.2016.12.005. Epub 2017 Jan 7.
PubMed 28577591
Pfammatter AF, Nahum-Shani I, DeZelar M, Scanlan L, McFadden HG, Siddique J, Hedeker D, Spring B. SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management. Contemp Clin Trials. 2019 Jul;82:36-45. doi: 10.1016/j.cct.2019.05.007. Epub 2019 May 23.
PubMed 31129369
Nahum-Shani I, Dziak JJ, Collins LM. Multilevel factorial designs with experiment-induced clustering. Psychol Methods. 2018 Sep;23(3):458-479. doi: 10.1037/met0000128. Epub 2017 Apr 6.
PubMed 28383950
Terry PE, Brown N, Arnett DK, Cushman M, Spring B, Halpern SD, Burke LE, Grossmeier J, Goetzel R, Lang J, Calitz C, Terry PE, Sanchez E. The Art of Health Promotion ideas for improving health outcomes. Am J Health Promot. 2016 Sep;30(7):563-82. doi: 10.1177/0890117116668866. No abstract available.
PubMed 27670659
Pellegrini CA, Conroy DE, Phillips SM, Pfammatter AF, McFadden HG, Spring B. Daily and Seasonal Influences on Dietary Self-monitoring Using a Smartphone Application. J Nutr Educ Behav. 2018 Jan;50(1):56-61.e1. doi: 10.1016/j.jneb.2016.12.004.
PubMed 29325663
Welch WA, Spring B, Phillips SM, Siddique J. Moderating Effects of Weather-Related Factors on a Physical Activity Intervention. Am J Prev Med. 2018 May;54(5):e83-e89. doi: 10.1016/j.amepre.2018.01.025. Epub 2018 Mar 15.
PubMed 29551330
Burke LE, Ma J, Azar KM, Bennett GG, Peterson ED, Zheng Y, Riley W, Stephens J, Shah SH, Suffoletto B, Turan TN, Spring B, Steinberger J, Quinn CC; American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council. Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 22;132(12):1157-213. doi: 10.1161/CIR.0000000000000232. Epub 2015 Aug 13. No abstract available.
PubMed 26271892
Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Collins LM, Mermelstein R, Fraser D, Fiore MC, Baker TB. A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care. Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059.
PubMed 30212849
Booth JN 3rd, Allen NB, Calhoun D, Carson AP, Deng L, Goff DC Jr, Redden DT, Reis JP, Shimbo D, Shikany JM, Sidney S, Spring B, Lewis CE, Muntner P. Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age. Am J Prev Med. 2019 Mar;56(3):368-375. doi: 10.1016/j.amepre.2018.10.020.
PubMed 30777156
Spring B, Pfammatter A, Alshurafa N. First Steps Into the Brave New Transdiscipline of Mobile Health. JAMA Cardiol. 2017 Jan 1;2(1):76-78. doi: 10.1001/jamacardio.2016.4440. No abstract available.
PubMed 27973672
Hoffman SA, Ledford G, Cameron KA, Phillips SM, Pellegrini CA. A qualitative exploration of social and environmental factors affecting diet and activity in knee replacement patients. J Clin Nurs. 2019 Apr;28(7-8):1156-1163. doi: 10.1111/jocn.14719. Epub 2018 Dec 10.
PubMed 30461097
Hekler EB, Michie S, Pavel M, Rivera DE, Collins LM, Jimison HB, Garnett C, Parral S, Spruijt-Metz D. Advancing Models and Theories for Digital Behavior Change Interventions. Am J Prev Med. 2016 Nov;51(5):825-832. doi: 10.1016/j.amepre.2016.06.013.
PubMed 27745682
Kheirkhahan M, Tudor-Locke C, Axtell R, Buman MP, Fielding RA, Glynn NW, Guralnik JM, King AC, White DK, Miller ME, Siddique J, Brubaker P, Rejeski WJ, Ranshous S, Pahor M, Ranka S, Manini TM. Actigraphy features for predicting mobility disability in older adults. Physiol Meas. 2016 Oct;37(10):1813-1833. doi: 10.1088/0967-3334/37/10/1813. Epub 2016 Sep 21.
PubMed 27653966

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Opt-IN: Optimization of Remotely Delivered Intensive Lifestyle Treatment for Obesity
ClinicalTrials.gov ID: NCT01814072
Acronym / sponsor ID: Opt-IN / NIH NIDDK R01DK097364-01
Conditions: Weight Loss
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 562 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Penn State University
Study start: Sep 2013
Primary completion: 20 Sep 2017 (actual)
Study completion: 20 Sep 2017 (actual)
First posted: 19 Mar 2013 (estimated)
Results: Posted 5 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 32

Arm	Type	Receives
Condition 1	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician1) Lifestyle Core; 2) 12 Telephone Coaching Sessions; 3) Report to Primary Care Physician
Condition 2	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements; 5) Buddy training via webinars
Condition 3	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 4	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 5	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Buddy training via webinars
Condition 6	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Recommendations to use meal replacements1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Recommendations to use meal replacements
Condition 7	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Text Messages1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages
Condition 8	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 9	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician
Condition 10	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Buddy training via webinars
Condition 11	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages; 5) Buddy training via webinars
Condition 12	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages
Condition 13	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Buddy training via webinars
Condition 14	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Recommendations to use meal replacements1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Recommendation to use meal replacements
Condition 15	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Text Messages1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages
Condition 16	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Regular text messages, 5) Buddy training via webinars
Condition 17	Experimental	Behavioral: 12 Telephone Coaching Sessions1) Lifestyle Core; 2) 12 Telephone Coaching Sessions
Condition 18	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Recommendations to use meal replacements; 4) Buddy training via webinars
Condition 19	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Text Messages, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 20	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements1) Lifestyle Core; 2) 12 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 21	Experimental	Behavioral: Report to Primary Care Physician, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Condition 22	Experimental	Behavioral: Report to Primary Care Physician1) Lifestyle Core; 2) 12 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendations to use meal replacements
Condition 23	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 24	Experimental	Behavioral: 12 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 12 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars
Condition 25	Experimental	Behavioral: 24 Telephone Coaching Sessions1) Lifestyle Core; 2) 24 telephone coaching sessions
Condition 26	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Recommendation to use meal replacements; 4) Buddy training via webinars
Condition 27	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Text Messages, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Buddy training via webinars
Condition 28	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements1) Lifestyle Core; 2) 24 telephone sessions; 3) Regular text messages; 4) Recommendation to use meal replacements
Condition 29	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Buddy training via webinars
Condition 30	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Recommendations to use meal replacements1) Lifestyle Core; 2) 24 telephone coaching sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements
Condition 31	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Regular text messages
Condition 32	Experimental	Behavioral: 24 Telephone Coaching Sessions, Behavioral: Report to Primary Care Physician, Behavioral: Text Messages, Behavioral: Recommendations to use meal replacements, Behavioral: Buddy Training1) Lifestyle Core; 2) 24 telephone sessions; 3) Report to Primary Care Physician; 4) Recommendation to use meal replacements; 5) Regular text messages, 6) Buddy training via webinars

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

18 and 60 years old
BMI 25-40 kg/m2
Weight stable (no loss or gain >25 lbs for the past 6 months)
Not enrolled in any formal weight loss program or taking anti-obesity medications, but interested in losing weight.
Own a Smartphone and be willing to install the Opt-IN app

Key exclusion criteria (12 listed)

Unstable medical conditions (uncontrolled hypertension, diabetes, unstable angina pectoris, myocardial infarction, transient ischemic attack, cancer undergoing active treatment, or cerebrovascular accident within the past six months)
History of diabetes requiring insulin supplementation, Crohn's Disease, or a diagnosis of obstructive sleep apnea requiring intervention (i.e. CPAP)
Use an assistive device for mobility (e.g., wheelchair, walker, cane)
Plantar fasciitis
Hospitalization for a psychiatric disorder within the past 5 years

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
12 Telephone Coaching SessionsParticipants will receive 12 telephone coaching sessions	Behavioural	Condition 1, Condition 17, Condition 18, Condition 19, Condition 2, Condition 20, Condition 23, Condition 24, Condition 3, Condition 4, Condition 5, Condition 6, Condition 7, Condition 8
24 Telephone Coaching SessionsParticipants will receive 24 telephone coaching sessions	Behavioural	Condition 10, Condition 11, Condition 12, Condition 13, Condition 14, Condition 15, Condition 16, Condition 25, Condition 26, Condition 27, Condition 28, Condition 29, Condition 30, Condition 31, Condition 32, Condition 9
Report to Primary Care PhysicianParticipants will have a report detailing their weight loss progress sent to their primary care physician	Behavioural	Condition 1, Condition 10, Condition 11, Condition 12, Condition 2, Condition 21, Condition 22, Condition 23, Condition 24, Condition 29, Condition 3, Condition 30, Condition 31, Condition 32, Condition 4, Condition 9
Text MessagesParticipants will receive regular text messages	Behavioural	Condition 11, Condition 12, Condition 15, Condition 16, Condition 19, Condition 20, Condition 23, Condition 24, Condition 27, Condition 28, Condition 3, Condition 31, Condition 32, Condition 4, Condition 7, Condition 8
Recommendations to use meal replacementsParticipants will receive recommendations from their coach to use meal replacements	Behavioural	Condition 10, Condition 12, Condition 14, Condition 16, Condition 18, Condition 2, Condition 20, Condition 24, Condition 26, Condition 28, Condition 30, Condition 32, Condition 4, Condition 6, Condition 8
Buddy TrainingParticipants will have a buddy that will be trained via webinars to be a supportive buddy	Behavioural	Condition 10, Condition 11, Condition 13, Condition 16, Condition 18, Condition 19, Condition 2, Condition 21, Condition 24, Condition 26, Condition 27, Condition 29, Condition 3, Condition 32, Condition 5, Condition 8

Primary outcome

Weight Change (kg) From Baseline to Month 6, Main Effect of Time
Time frame: From Baseline to Month 6
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis).
Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction
Time frame: From Baseline to Month 6
Estimated mean change from Baseline to Month 6 were obtained from a linear mixed models analysis of variance to account for missing data. All randomized participants were utilized in the model (ITT analysis). This outcome measure is reported as an additional effect beyond that of Outcome Measure 1 (each component has it's own weight loss effect that is above and beyond the weight change calculated in the Outcome Measure 1 analyses).

1 secondary outcome

Intervention for <$500
Time frame: 6 months

Results and safety

Results posted to the registry on 5 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
1. 12 Calls, PCP	18	14
2. 12 Calls, PCP, MR, Buddy	18	16
3. 12 Calls, PCP, Texts, Buddy	18	15
4. 12 Calls, PCP, Texts, MR	18	18
5. 12 Calls, Buddy	18	14
6. 12 Calls, MR	18	12
7. 12 Calls, Texts	18	14
8. 12 Calls, Texts, MR, Buddy	18	17
9. 24 Calls, PCP	19	16
10. 24 Calls, PCP, MR, Buddy	18	13
11. 24 Calls, PCP, Texts, Buddy	18	17
12. 24 Calls, PCP, Texts, MR	18	16
13. 24 Calls, Buddy	18	15
14. 24 Calls, MR	18	16
15. 24 Calls, Texts	18	15
16. 24 Calls, Texts, MR, Buddy	18	16
17. 12 Calls	17	14
18. 12 Calls, MR, Buddy	18	17
19. 12 Calls, Texts, Buddy	17	14
20. 12 Calls, Texts, MR	16	11
21. 12 Calls, PCP, Buddy	16	14
22. 12 Calls, PCP, MR	17	16
23. 12 Calls PCP, Texts	17	13
24. 12 Calls, PCP, Texts, MR, Buddy	18	17
25. 24 Calls	17	11
26. 24 Calls, MR, Buddy	16	14
27. 24 Calls, Texts, Buddy	18	16
28. 24 Calls, Texts, MR	17	13
29. 24 Calls, PCP, Buddy	18	14
30. 24 Calls, PCP, MR	17	14
31. 24 Calls, PCP, Texts	17	15
32. 24 Calls, PCP, Texts, MR, Buddy	17	17

Primary outcome: Weight Change (kg) From Baseline to Month 6, Main Effect of Time

Time frame: From Baseline to Month 6. Mean (95% Confidence Interval). Unit: Kg

Measure	All Reporting Groups n = 562
Value	-4.8 (-5.3 to -4.4)

All Reporting Groups: p <.001, Mixed Models Analysis

Population analysed: ITT population: all randomized participants with at least one weight value. The decision to analyze all randomized participants together for aim 1, rather than separately by arm, was pre-specified in the the Protocol/Statistical Analysis Plan for the purposes of assessing the main effect of time.

Primary outcome: Weight Change (kg) From Baseline to Month 6, Time by Factor Interaction

Time frame: From Baseline to Month 6. Mean (95% Confidence Interval). Unit: Kg

Measure	Coaching Calls n = 562	PCP Reports n = 562	Text Messages n = 562	Meal Replacements n = 562	Buddy Training n = 562
Value	.1244 (-.3026 to .5513)	-.0226 (-.4495 to .4044)	.0840 (-.3429 to .5109)	.1081 (-.3188 to .5350)	-.4353 (-.8622 to -.0084)

Coaching Calls: Estimated Change: 0.1244 (95% CI -.3026 to .5513), p = 0.567, Mixed Models Analysis
PCP Reports: Estimated Change: -0.0226 (95% CI -.4495 to .4044), p = 0.917, Mixed Models Analysis
Text Messages: Estimated Change: 0.084 (95% CI -.3429 to .5109), p = 0.699, Mixed Models Analysis

Population analysed: ITT population: all randomized participants with at least one weight value.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected from randomization to 6-month follow-up. All 562 participants in the study were enrolled between 2013 and 2017.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Condition 1	0 of 18 (0%)	6 of 18 (33.3%)	0 of 18
Condition 2	0 of 18 (0%)	8 of 18 (44.4%)	0 of 18
Condition 3	0 of 18 (0%)	7 of 18 (38.9%)	0 of 18
Condition 4	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
Condition 5	1 of 18 (5.6%)	4 of 18 (22.2%)	0 of 18
Condition 6	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
Condition 7	0 of 18 (0%)	5 of 18 (27.8%)	0 of 18
Condition 8	0 of 18 (0%)	8 of 18 (44.4%)	0 of 18
Condition 9	0 of 19 (0%)	8 of 18 (44.4%)	0 of 19
Condition 10	0 of 18 (0%)	8 of 18 (44.4%)	0 of 18
Condition 11	0 of 18 (0%)	4 of 18 (22.2%)	0 of 18
Condition 12	0 of 18 (0%)	9 of 18 (50%)	0 of 18
Condition 13	0 of 18 (0%)	7 of 18 (38.9%)	0 of 18
Condition 14	0 of 18 (0%)	8 of 18 (44.4%)	0 of 18
Condition 15	0 of 18 (0%)	8 of 18 (44.4%)	0 of 18
Condition 16	1 of 18 (5.6%)	8 of 18 (44.4%)	0 of 18
Condition 17	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17
Condition 18	0 of 18 (0%)	2 of 18 (11.1%)	0 of 18
Condition 19	0 of 17 (0%)	1 of 17 (5.9%)	0 of 17
Condition 20	0 of 16 (0%)	2 of 16 (12.5%)	0 of 16

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 17466815Collins LM, Murphy SA, Strecher V. The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. Am J Prev Med. 2007 May;32(5 Suppl):S112-8. doi: 10.1016/j.amepre.2007.01.022.
Background: PubMed 27663578Nahum-Shani I, Smith SN, Spring BJ, Collins LM, Witkiewitz K, Tewari A, Murphy SA. Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health: Key Components and Design Principles for Ongoing Health Behavior Support. Ann Behav Med. 2018 May 18;52(6):446-462. doi: 10.1007/s12160-016-9830-8.
Background: PubMed 28577591Baker TB, Smith SS, Bolt DM, Loh WY, Mermelstein R, Fiore MC, Piper ME, Collins LM. Implementing Clinical Research Using Factorial Designs: A Primer. Behav Ther. 2017 Jul;48(4):567-580. doi: 10.1016/j.beth.2016.12.005. Epub 2017 Jan 7.
Background: PubMed 31129369Pfammatter AF, Nahum-Shani I, DeZelar M, Scanlan L, McFadden HG, Siddique J, Hedeker D, Spring B. SMART: Study protocol for a sequential multiple assignment randomized controlled trial to optimize weight loss management. Contemp Clin Trials. 2019 Jul;82:36-45. doi: 10.1016/j.cct.2019.05.007. Epub 2019 May 23.
Background: PubMed 28383950Nahum-Shani I, Dziak JJ, Collins LM. Multilevel factorial designs with experiment-induced clustering. Psychol Methods. 2018 Sep;23(3):458-479. doi: 10.1037/met0000128. Epub 2017 Apr 6.
Background: PubMed 27670659Terry PE, Brown N, Arnett DK, Cushman M, Spring B, Halpern SD, Burke LE, Grossmeier J, Goetzel R, Lang J, Calitz C, Terry PE, Sanchez E. The Art of Health Promotion ideas for improving health outcomes. Am J Health Promot. 2016 Sep;30(7):563-82. doi: 10.1177/0890117116668866. No abstract available.
Background: PubMed 29325663Pellegrini CA, Conroy DE, Phillips SM, Pfammatter AF, McFadden HG, Spring B. Daily and Seasonal Influences on Dietary Self-monitoring Using a Smartphone Application. J Nutr Educ Behav. 2018 Jan;50(1):56-61.e1. doi: 10.1016/j.jneb.2016.12.004.
Background: PubMed 29551330Welch WA, Spring B, Phillips SM, Siddique J. Moderating Effects of Weather-Related Factors on a Physical Activity Intervention. Am J Prev Med. 2018 May;54(5):e83-e89. doi: 10.1016/j.amepre.2018.01.025. Epub 2018 Mar 15.
Background: PubMed 26271892Burke LE, Ma J, Azar KM, Bennett GG, Peterson ED, Zheng Y, Riley W, Stephens J, Shah SH, Suffoletto B, Turan TN, Spring B, Steinberger J, Quinn CC; American Heart Association Publications Committee of the Council on Epidemiology and Prevention, Behavior Change Committee of the Council on Cardiometabolic Health, Council on Cardiovascular and Stroke Nursing, Council on Functional Genomics and Translational Biology, Council on Quality of Care and Outcomes Research, and Stroke Council. Current Science on Consumer Use of Mobile Health for Cardiovascular Disease Prevention: A Scientific Statement From the American Heart Association. Circulation. 2015 Sep 22;132(12):1157-213. doi: 10.1161/CIR.0000000000000232. Epub 2015 Aug 13. No abstract available.
Background: PubMed 30212849Piper ME, Cook JW, Schlam TR, Jorenby DE, Smith SS, Collins LM, Mermelstein R, Fraser D, Fiore MC, Baker TB. A Randomized Controlled Trial of an Optimized Smoking Treatment Delivered in Primary Care. Ann Behav Med. 2018 Sep 13;52(10):854-864. doi: 10.1093/abm/kax059.
Background: PubMed 30777156Booth JN 3rd, Allen NB, Calhoun D, Carson AP, Deng L, Goff DC Jr, Redden DT, Reis JP, Shimbo D, Shikany JM, Sidney S, Spring B, Lewis CE, Muntner P. Racial Differences in Maintaining Optimal Health Behaviors Into Middle Age. Am J Prev Med. 2019 Mar;56(3):368-375. doi: 10.1016/j.amepre.2018.10.020.
Background: PubMed 27973672Spring B, Pfammatter A, Alshurafa N. First Steps Into the Brave New Transdiscipline of Mobile Health. JAMA Cardiol. 2017 Jan 1;2(1):76-78. doi: 10.1001/jamacardio.2016.4440. No abstract available.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bonnie Spring, PhD principal investigator

Northwestern University

Linda Collins, PhD principal investigator

Penn State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Change (kg) From Baseline to Month 6, Main Effect of Time (time frame: From Baseline to Month 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01814072, which also lists 33 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.