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ObesityNCT01827800

New Media Obesity Treatment in Community Health Centers

A study testing eHealth weight loss intervention in people with Obesity, run by Duke 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

This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a… Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Obesity
What is being tested?
eHealth weight loss intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
351 participants
Where
1 siteUnited States
Study dates
Jun 2013to 31 Jul 2018
Phase
Interventional
Are there results?
None posted in the registry

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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 1 visit in the previous 12 months to an adult medicine, internal medicine, or family practice provider at a participating community health center
  • BMI between 30.0-45.0 kg/m2 and weight ≤ 320 pounds
  • Diagnosis of hypertension or diabetes

Who cannot join

  • Current pregnancy
  • Pregnancy in previous 12 months
  • Heart attack/stroke in previous 2 years
  • Active cancer diagnosis
  • Current participation in another weight loss study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Duke University

    Durham, North Carolina, 27705

Other trials in United States

About this study

This purpose of this trial is to determine whether a 12-month eHealth behavioral intervention that includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls, and primary care physician (PCP) counseling will produce greater weight change at 12 months than a standard primary care control.

Read the detailed description

This is a patient randomized trial in which patients will be randomized into one of two treatment arms: 1) standard primary care; or 2) primary care plus a 12-month eHealth behavioral intervention (iOTA), which includes interactive self-monitoring and feedback, tailored skills training materials, 18 telephone counseling calls, and primary care provider counseling. The primary outcome is weight change at 12 months. Participants will be 351 adult male and female patients from local community health centers with obesity and a related comorbidity.

Conditions
Obesity
Being tested
eHealth weight loss intervention
Keywords
weight loss, primary care, eHealth
Medical subject headings
Obesity, Weight Loss

What participants receive

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

  • eHealth weight loss interventionBehavioural

    This trial involves a multi-level, systems-change weight loss intervention. At the provider level, we make it easier for PCPs to deliver weight loss counseling by embedding patient progress data and counseling recommendations in the electronic health record. At the patient level, we provide engaging self-monitoring interfaces, immediate tailored feedback, skills training, and evidence-based lifestyle counseling from trusted care providers.

Study groups in NCT01827800
Study groupRoleWhat they receive
eHealth weight loss interventionExperimentalThe 12-month eHealth behavioral intervention includes interactive self-monitoring and feedback, tailored skills training materials, telephone counseling calls from a study coach, and primary care provider counseling.
Receives: Behavioral: eHealth weight loss intervention
Usual careNo interventionParticipants in the usual care arm will receive the usual primary care services offered by their community health center primary care providers.

What is being measured

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

  1. Weight change

    Weight will be measured at baseline and 12 months using a SECA 876 scale.

    Measured: Baseline - 12 months

Secondary outcomes (6)

  1. The achievement and maintenance of > 5% weight loss

    Weight will be measured at baseline and 12 months using a SECA 876 scale.

    Measured: Baseline - 12 months

  2. Diet

    Dietary assessments will be performed at baseline and 12 months using the ASA24, a self-administered dietary recall measure developed by the National Cancer Institute.

    Measured: Baseline - 12 months

  3. Cardiometabolic risk markers

    Risk markers include waist circumference, systolic and diastolic blood pressure, lipid panel and A1c levels

    Measured: Baseline - 12 months

  4. Global Framingham risk score

    The Framingham Risk Score is a validated scoring system used to determine an individual's chances of developing cardiovascular disease. We will calculate this score at baseline and 12 months.

    Measured: Baseline - 12 months

  5. An evaluation of the intervention's impact and dissemination potential using the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework

    RE-AIM was originally developed as a framework for consistent reporting of research results and later used to organize reviews of the existing literature on health promotion and disease management in different settings. The acronym stands for Reach, Effectiveness, Adoption, Implementation, and Maintenance which together determine public health impact. More recently, RE-AIM has been used to translate research into practice and to help plan programs and improve their chances of working in "real-world" settings. The framework has also been used to understand the relative strengths and weaknesses of different approaches to health promotion and chronic disease self-management-such as in-person counseling, group education classes, telephone counseling, and internet resources.

    Measured: 12 and 24 months

  6. Physical activity

    Physical activity will be measured at baseline and 12 months using the GPAQ (the Global Physical Activity Questionnaire developed by the World Health Organization).

    Measured: Baseline -12 months

Timeline

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

  1. First posted10 Apr 2013 (estimated)
  2. Study startJun 2013
  3. Primary completionSep 2015
  4. Study completion31 Jul 2018

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01827800
Sponsor's protocol ID
B0033
Status last verified
Aug 2018
First submitted
3 Apr 2013
Last updated
13 Aug 2018
Results posted
No
Data monitoring committee
Yes

Publications

  • Gallis JA, Kusibab K, Egger JR, Olsen MK, Askew S, Steinberg DM, Bennett G. Can Electronic Health Records Validly Estimate the Effects of Health System Interventions Aimed at Controlling Body Weight? Obesity (Silver Spring). 2020 Nov;28(11):2107-2115. doi: 10.1002/oby.22958. Epub 2020 Sep 27.

    PubMed 32985131

  • Steinberg D, Kay M, Burroughs J, Svetkey LP, Bennett GG. The Effect of a Digital Behavioral Weight Loss Intervention on Adherence to the Dietary Approaches to Stop Hypertension (DASH) Dietary Pattern in Medically Vulnerable Primary Care Patients: Results from a Randomized Controlled Trial. J Acad Nutr Diet. 2019 Apr;119(4):574-584. doi: 10.1016/j.jand.2018.12.011.

    PubMed 30905430

  • McVay M, Steinberg D, Askew S, Bennett GG. Provider Counseling and Weight Loss Outcomes in a Primary Care-Based Digital Obesity Treatment. J Gen Intern Med. 2019 Jun;34(6):992-998. doi: 10.1007/s11606-019-04944-5. Epub 2019 Mar 19.

    PubMed 30891688

  • Bennett GG, Steinberg D, Askew S, Levine E, Foley P, Batch BC, Svetkey LP, Bosworth HB, Puleo EM, Brewer A, DeVries A, Miranda H. Effectiveness of an App and Provider Counseling for Obesity Treatment in Primary Care. Am J Prev Med. 2018 Dec;55(6):777-786. doi: 10.1016/j.amepre.2018.07.005. Epub 2018 Oct 22.

    PubMed 30361140

  • Foley P, Steinberg D, Levine E, Askew S, Batch BC, Puleo EM, Svetkey LP, Bosworth HB, DeVries A, Miranda H, Bennett GG. Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients. Contemp Clin Trials. 2016 May;48:12-20. doi: 10.1016/j.cct.2016.03.006. Epub 2016 Mar 17.

    PubMed 26995281

Questions about this trial

What is this clinical trial studying?

A study testing eHealth weight loss intervention in people with Obesity, run by Duke University at 1 site in United States.

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 3 inclusion and 5 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 13 Aug 2018. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (time frame: Baseline - 12 months). 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 NCT01827800, which also lists 5 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 13 Aug 2018.

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