ObesityNCT03337139
FitLink: Improving Weight Loss Maintenance by Using Digital Data to Provide Support and Accountability
A study testing Gold Standard Behavior Therapy for Weight Loss, Standard Remote Behavior Therapy for Weight Loss and Digital Data Sharing Behavior Therapy for Weight Loss in people with Obesity and Overweight, run by Drexel University at 1 site in United States.
Trial summary
Most adults in the U.S. are overweight or obese and find maintenance of weight loss difficult. This study is designed to aid in the development of a lifestyle modification program that can facilitate weight loss maintenance, without requiring long-term visits to a clinic for maintenance treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity, Overweight, Overweight and Obesity
- What is being tested?
- Gold Standard Behavior Therapy for Weight Loss, Standard Remote Behavior Therapy for Weight Loss and Digital Data Sharing Behavior Therapy for Weight Loss
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2017to 31 May 2019
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-70 years with a BMI of 25-45 kg/m2 and weight <160 kg
- Access to a smartphone
- Satisfactory completion of all enrollment procedures
- Ability to engage in physical activity (i.e. can walk at least 2 blocks without stopping for rest)
Who cannot join
- Medical condition (i.e. acute coronary syndrome, type 1 diabetes, renal failure) or psychiatric condition (i.e. active substance abuse, eating disorder) that may:
- Pose a risk to the participant during the intervention
- Cause a change in weight
- Limit ability to comply with the behavioral recommendations of the program
- Pregnant or planning pregnancy in the next 1 year
- Planned move out of the Philadelphia area during the data collection period
Show all 10Show fewer
- Use of a pacemaker (incompatible with wireless scale technology)
- Recently began or changed the dosage of a medication that can cause significant change in weight
- History of bariatric surgery
- Weight loss of > 10% in the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Weight Loss Maintenance by Using Digital Data Sharing to Provide Responsive Support and Accountability
Most adults in the U.S. are overweight or obese and find maintenance of weight loss difficult. This study is designed to aid in the development of a lifestyle modification program that can facilitate weight loss maintenance, without requiring long-term visits to a clinic for maintenance treatment.
Read the detailed description
In a lifestyle modification program, contact with an interventionist (e.g., weight loss coach) creates a sense of supportive accountability that can facilitate behavior change and weight loss. Sustaining a strong sense of supportive accountability after face-to-face intervention contact ends has the potential to improve outcomes during the notoriously difficult weight loss maintenance period. One innovative way of facilitating supportive accountability is providing participants with digital tools that objectively measure weight and physical activity and track food intake in real-time, making the data from those tools automatically and continuously available to coaches, and designing the timing and content of intervention contacts such that they are responsive to the shared data. Although tools that allow for data sharing from sensors and Internet-based applications are readily available, the ways in which they are integrated into intervention contacts in a lifestyle modification program are not yet optimized, and research has not systematically evaluated the effect of data sharing on behavior. Overweight and obese participants (n = 90) will be recruited from the community for a small randomized controlled trial in order to test the feasibility, acceptability, efficacy, and mechanisms of action of a lifestyle modification intervention enhanced with data sharing. In weeks 1-12 of the program (i.e., Phase I), all participants will attend 12 weekly, face-to-face, group-based behavioral treatment sessions to induce weight loss. Participants will be provided with a wireless body weight scale, physical activity sensor, and digital food record app and instructed to use them daily use for self-monitoring purposes. In Phase II (weeks 13-52), participants will be randomly assigned to the standard (LM) or enhanced version of remote lifestyle modification (LM+SHARE). Neither condition will have face-to-face intervention contact during Phase II; remote intervention contact will consist of brief phone calls and text messages provided by the participant's coach. Participants in both conditions will be prescribed continued daily use of the three self-monitoring devices. In the standard LM condition, no digital data from these devices will be directly shared with coaches; intervention encounters will be informed only by the infrequent, delayed self-report of participants (which is the current standard of long-term obesity care), and timing of text messages will be fixed. In LM+SHARE, the digital tools will automatically and continuously transmit body weight, physical activity, and food record data to the coach. In LM+SHARE, supportive accountability will be enhanced in three ways: 1) participants will receive automated alerts after coaches view their data, 2) timing of personalized text messages from coaches will be responsive to clinically notable change in weight, physical activity, calorie intake, or use of scale, physical activity sensor, or food record tool, and 3) content of the text messages and phone calls will be informed by the digital data the coach has viewed, as well as the expectation that the coach will continue viewing data in order to provide ongoing support. Assessments will be completed at 0, 12, 26, and 52 weeks.
- Conditions
- Obesity, Overweight, Overweight and Obesity, Weight Loss
- Being tested
- Gold Standard Behavior Therapy for Weight Loss, Standard Remote Behavior Therapy for Weight Loss, Digital Data Sharing Behavior Therapy for Weight Loss
- Keywords
- Weight Loss, Obesity, Overweight, Behavioral Weight Loss
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gold Standard Behavior Therapy for Weight LossBehavioural
Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.
Standard Remote Behavior Therapy for Weight LossBehavioural
Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.
Digital Data Sharing Behavior Therapy for Weight LossBehavioural
Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Modification | Active comparator | Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. Receives: Behavioral: Gold Standard Behavior Therapy for Weight Loss; Behavioral: Standard Remote Behavior Therapy for Weight Loss |
| Lifestyle Modification + Share | Experimental | Three months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. Receives: Behavioral: Gold Standard Behavior Therapy for Weight Loss; Behavioral: Digital Data Sharing Behavior Therapy for Weight Loss |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Body Weight
Objectively measured in the research clinic at each time point on a scale. Reported as weight change in kg, where negative numbers reflect weight loss and positive numbers reflect weight gain.
Measured: 0, 13, 26, 52 weeks
Change in Physical Activity
Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
Measured: 13, 52 weeks
Number of Participants Retained
Feasibility and acceptability metric of retention.
Measured: 26, 52 weeks
Number of Completed Treatment Contacts
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
Measured: 52 weeks
Treatment Acceptability Questionnaire (TAQ)
Feasibility and acceptability metric of scores on the TAQ. Items on the TAQ consisted of 11 questions on a 7 point Likert scale asking about helpfulness and acceptability of treatment components. Items are summed to yield a total score that can range from 11-77 with higher numbers indicated higher acceptability.
Measured: 52 weeks
Secondary outcomes (2)
Self-monitoring Engagement
Use of digital devices; percent of days during which weight, food, and steps were counted in Phase II. Percent calculated for each group (LM vs. LM+Share) and not for individual participants. We determined percent to be the metric that would be most easily interpreted and it accounted for any possible variability in total number of days of observations.
Measured: 13-52 weeks
Perceived Accountability
Change in "Perceptions of Accountability" subscale of the Supportive Accountability Scale. The measure used was a 10-item scale on which participants rated the extent to which they agreed with statements on a 7-point likert scale. A total score was generated by summing scores from individual items. Total scores ranged from 10-70 with higher scorings indicating higher perceived accountability. The outcome measure reported here is the change in total score on this measure (decrease) across Phase II where a negative score reflects a decrease in perceived accountability.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2017
- Study start17 Nov 2017
- Primary completion31 May 2019
- Study completion31 May 2019
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 (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Behavioral and Social Sciences Research (OBSSR)
- Responsible party
- Principal investigator, Meghan Butryn, Drexel University
- Investigators
- Meghan L Butryn, Ph.D., Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03337139
- Sponsor's protocol ID
- 1611004954
- Other IDs
- R21DK112741
- Status last verified
- Dec 2020
- First submitted
- 7 Nov 2017
- Last updated
- 5 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Butryn ML, Martinelli MK, Crane NT, Godfrey K, Roberts SR, Zhang F, Forman EM. Counselor Surveillance of Digital Self-Monitoring Data: A Pilot Randomized Controlled Trial. Obesity (Silver Spring). 2020 Dec;28(12):2339-2346. doi: 10.1002/oby.23015. Epub 2020 Oct 23.
PubMed 33098278Schumacher LM, Martinelli MK, Convertino AD, Forman EM, Butryn ML. Weight-Related Information Avoidance Prospectively Predicts Poorer Self-Monitoring and Engagement in a Behavioral Weight Loss Intervention. Ann Behav Med. 2021 Mar 16;55(2):103-111. doi: 10.1093/abm/kaaa034.
PubMed 32491152
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Weight Loss Maintenance by Using Digital Data Sharing to Provide Responsive Support and Accountability
- ClinicalTrials.gov ID
- NCT03337139
- Acronym / sponsor ID
- 1611004954
- Conditions
- Obesity, Overweight, Overweight and Obesity, Weight Loss
- Keywords
- Weight Loss, Obesity, Overweight, Behavioral Weight Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Office of Behavioral and Social Sciences Research (OBSSR)
- Study start
- 17 Nov 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 8 Nov 2017 (actual)
- 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.
Most adults in the U.S. are overweight or obese and find maintenance of weight loss difficult. This study is designed to aid in the development of a lifestyle modification program that can facilitate weight loss maintenance, without requiring long-term visits to a clinic for maintenance treatment.
Detailed description
In a lifestyle modification program, contact with an interventionist (e.g., weight loss coach) creates a sense of supportive accountability that can facilitate behavior change and weight loss. Sustaining a strong sense of supportive accountability after face-to-face intervention contact ends has the potential to improve outcomes during the notoriously difficult weight loss maintenance period. One innovative way of facilitating supportive accountability is providing participants with digital tools that objectively measure weight and physical activity and track food intake in real-time, making the data from those tools automatically and continuously available to coaches, and designing the timing and content of intervention contacts such that they are responsive to the shared data. Although tools that allow for data sharing from sensors and Internet-based applications are readily available, the ways in which they are integrated into intervention contacts in a lifestyle modification program are not yet optimized, and research has not systematically evaluated the effect of data sharing on behavior. Overweight and obese participants (n = 90) will be recruited from the community for a small randomized controlled trial in order to test the feasibility, acceptability, efficacy, and mechanisms of action of a lifestyle modification intervention enhanced with data sharing. In weeks 1-12 of the program (i.e., Phase I), all participants will attend 12 weekly, face-to-face, group-based behavioral treatment sessions to induce weight loss. Participants will be provided with a wireless body weight scale, physical activity sensor, and digital food record app and instructed to use them daily use for self-monitoring purposes. In Phase II (weeks 13-52), participants will be randomly assigned to the standard (LM) or enhanced version of remote lifestyle modification (LM+SHARE). Neither condition will have face-to-face intervention contact during Phase II; remote intervention contact will consist of brief phone calls and text messages provided by the participant's coach. Participants in both conditions will be prescribed continued daily use of the three self-monitoring devices. In the standard LM condition, no digital data from these devices will be directly shared with coaches; intervention encounters will be informed only by the infrequent, delayed self-report of participants (which is the current standard of long-term obesity care), and timing of text messages will be fixed. In LM+SHARE, the digital tools will automatically and continuously transmit body weight, physical activity, and food record data to the coach. In LM+SHARE, supportive accountability will be enhanced in three ways: 1) participants will receive automated alerts after coaches view their data, 2) timing of personalized text messages from coaches will be responsive to clinically notable change in weight, physical activity, calorie intake, or use of scale, physical activity sensor, or food record tool, and 3) content of the text messages and phone calls will be informed by the digital data the coach has viewed, as well as the expectation that the coach will continue viewing data in order to provide ongoing support. Assessments will be completed at 0, 12, 26, and 52 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Modification | Active comparator | Behavioral: Gold Standard Behavior Therapy for Weight Loss, Behavioral: Standard Remote Behavior Therapy for Weight LossThree months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on self-report. |
| Lifestyle Modification + Share | Experimental | Behavioral: Gold Standard Behavior Therapy for Weight Loss, Behavioral: Digital Data Sharing Behavior Therapy for Weight LossThree months of standard, group-based behavioral treatment for weight loss and nine months of remote individual behavioral treatment based on digital data shared with clinicians. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18-70 years with a BMI of 25-45 kg/m2 and weight <160 kg
- Access to a smartphone
- Satisfactory completion of all enrollment procedures
- Ability to engage in physical activity (i.e. can walk at least 2 blocks without stopping for rest)
Key exclusion criteria (10 listed)
- Medical condition (i.e. acute coronary syndrome, type 1 diabetes, renal failure) or psychiatric condition (i.e. active substance abuse, eating disorder) that may:
- Pregnant or planning pregnancy in the next 1 year
- Planned move out of the Philadelphia area during the data collection period
- Use of a pacemaker (incompatible with wireless scale technology)
- Recently began or changed the dosage of a medication that can cause significant change in weight
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 |
|---|---|---|
| Gold Standard Behavior Therapy for Weight LossGroup-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. | Behavioural | Lifestyle Modification, Lifestyle Modification + Share |
| Standard Remote Behavior Therapy for Weight LossIndividual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices. | Behavioural | Lifestyle Modification |
| Digital Data Sharing Behavior Therapy for Weight LossIndividual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices. | Behavioural | Lifestyle Modification + Share |
Primary outcome
Change in Body Weight
Time frame: 0, 13, 26, 52 weeks
Objectively measured in the research clinic at each time point on a scale. Reported as weight change in kg, where negative numbers reflect weight loss and positive numbers reflect weight gain.
Change in Physical Activity
Time frame: 13, 52 weeks
Objectively measured using wGT3X-BT accelerometers from Actigraph. Minutes/week of moderate-to-vigorous physical activity (MVPA).
Number of Participants Retained
Time frame: 26, 52 weeks
Feasibility and acceptability metric of retention.
Number of Completed Treatment Contacts
Time frame: 52 weeks
Feasibility and acceptability metric of completed treatment contacts (phone calls and text messages).
Treatment Acceptability Questionnaire (TAQ)
Time frame: 52 weeks
Feasibility and acceptability metric of scores on the TAQ. Items on the TAQ consisted of 11 questions on a 7 point Likert scale asking about helpfulness and acceptability of treatment components. Items are summed to yield a total score that can range from 11-77 with higher numbers indicated higher acceptability.
2 secondary outcomes
Self-monitoring Engagement
Time frame: 13-52 weeks
Perceived Accountability
Time frame: 52 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33098278Butryn ML, Martinelli MK, Crane NT, Godfrey K, Roberts SR, Zhang F, Forman EM. Counselor Surveillance of Digital Self-Monitoring Data: A Pilot Randomized Controlled Trial. Obesity (Silver Spring). 2020 Dec;28(12):2339-2346. doi: 10.1002/oby.23015. Epub 2020 Oct 23.
- Derived from this study: PubMed 32491152Schumacher LM, Martinelli MK, Convertino AD, Forman EM, Butryn ML. Weight-Related Information Avoidance Prospectively Predicts Poorer Self-Monitoring and Engagement in a Behavioral Weight Loss Intervention. Ann Behav Med. 2021 Mar 16;55(2):103-111. doi: 10.1093/abm/kaaa034.
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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.
Meghan L Butryn, Ph.D. principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gold Standard Behavior Therapy for Weight Loss, Standard Remote Behavior Therapy for Weight Loss and Digital Data Sharing Behavior Therapy for Weight Loss in people with Obesity and Overweight, run by Drexel 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 4 inclusion and 10 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 5 Jan 2021. 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?
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?
Change in Body Weight (time frame: 0, 13, 26, 52 weeks). The study lists 5 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 NCT03337139, which also lists 2 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 5 Jan 2021.