ObesityNCT02691260
Incentivizing Behavior Change Skills to Promote Weight Loss
A study testing incentives for dietary self-monitoring, incentives for interim weight loss and incentives for both in people with Obesity, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- incentives for dietary self-monitoring, incentives for interim weight loss and incentives for both
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- desire to lose weight;
- agree to attend visits per protocol;
- access to telephone and transportation;
- English speaking;
- able to complete study measures;
- smart phone with data and texting plan;
- body mass index 30 kg/m2 or greater
Who cannot join
- pregnancy, breastfeeding, or lack of birth control if premenopausal
- dementia, excessive alcohol use, or psychiatric illness
- weight loss >4.5 kg in month prior to screening
- weight > 380 lb (due to limit of cellular scale)
- enrollment in other weight loss program
- residing in nursing home or receiving home health care
Show all 14Show fewer
- unable to attend weight loss group at scheduled times
- impaired hearing
- medication other than metformin, incretin mimetics and incretin enhances for type 2 diabetes
- unstable heart disease in 3 months prior to screening
- furosemide 40 mg or higher (or equivalent)
- chronic kidney disease
- 2 or more errors on cognitive screener
- blood pressure ≥160/100 mmHg
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.
Read the detailed description
In this study, community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. An innovative information technology (IT) solution will collate dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. Participants will be notified of earning rewards via text messaging.
- Conditions
- Obesity
- Being tested
- incentives for dietary self-monitoring, incentives for interim weight loss, incentives for both
- Keywords
- obesity, behavioral intervention, diet
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
incentives for dietary self-monitoringBehavioural
Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.
incentives for interim weight lossBehavioural
Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.
incentives for bothBehavioural
Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly.
| Study group | Role | What they receive |
|---|---|---|
| no incentives | No intervention | Participants do not receive financial incentives. |
| incentives for dietary self-monitoring | Active comparator | Participants receive financial incentives for dietary self-monitoring. Receives: Behavioral: incentives for dietary self-monitoring |
| incentives for interim weight loss | Active comparator | Participants receive financial incentives for interim weight loss. Receives: Behavioral: incentives for interim weight loss |
| incentives for both | Experimental | Participants receive incentives for dietary self-monitoring and interim weight loss. Receives: Behavioral: incentives for both |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change From Baseline to 24 Weeks
Measured in pounds
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2018
- Study completionMay 2018
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 (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Duke 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Ryan J Shaw, PhD, RN, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02691260
- Sponsor's protocol ID
- Pro00056410
- Other IDs
- 1R34HL125669-01A1
- Status last verified
- Aug 2019
- First submitted
- 22 Feb 2016
- Last updated
- 5 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Voils CI, Levine E, Gierisch JM, Pendergast J, Hale SL, McVay MA, Reed SD, Yancy WS Jr, Bennett G, Strawbridge EM, White AC, Shaw RJ. Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity. Contemp Clin Trials. 2018 Feb;65:116-122. doi: 10.1016/j.cct.2017.12.007. Epub 2017 Dec 28.
PubMed 29289702Gavin KL, Almeida EJ, Voils CI, Crane MM, Shaw R, Yancy WS Jr, Pendergast J, Olsen MK. Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method. Obes Sci Pract. 2023 Jan 12;9(4):337-345. doi: 10.1002/osp4.656. eCollection 2023 Aug.
PubMed 37546286Voils CI, Pendergast J, Hale SL, Gierisch JM, Strawbridge EM, Levine E, McVay MA, Reed SD, Yancy WS, Shaw RJ. A randomized feasibility pilot trial of a financial incentives intervention for dietary self-monitoring and weight loss in adults with obesity. Transl Behav Med. 2021 Apr 26;11(4):954-969. doi: 10.1093/tbm/ibaa102.
PubMed 33245118Shaw R, Levine E, Streicher M, Strawbridge E, Gierisch J, Pendergast J, Hale S, Reed S, McVay M, Simmons D, Yancy W, Bennett G, Voils C. Log2Lose: Development and Lessons Learned From a Mobile Technology Weight Loss Intervention. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11972. doi: 10.2196/11972.
PubMed 30758297
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incentivizing Behavior Change Skills to Promote Weight Loss
- ClinicalTrials.gov ID
- NCT02691260
- Acronym / sponsor ID
- Pro00056410
- Conditions
- Obesity
- Keywords
- obesity, behavioral intervention, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Apr 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 25 Feb 2016 (estimated)
- Results
- Posted 5 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the feasibility of providing incentives to people enrolled in a weight-loss program for dietary self-monitoring and/or interim weight loss.
Detailed description
In this study, community outpatients will participate in an effective, 24-week, low-carbohydrate weight loss program delivered via biweekly group classes. An innovative information technology (IT) solution will collate dietary self-monitoring data (input by patients via a mobile phone dietary application) and weight loss data (input by patients via remote scale). An algorithm will classify participants as achieving adequate or inadequate dietary self-monitoring and weight loss to earn intermittent rewards of varying value in real-time. Participants will be notified of earning rewards via text messaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| no incentives | No intervention | –Participants do not receive financial incentives. |
| incentives for dietary self-monitoring | Active comparator | Behavioral: incentives for dietary self-monitoringParticipants receive financial incentives for dietary self-monitoring. |
| incentives for interim weight loss | Active comparator | Behavioral: incentives for interim weight lossParticipants receive financial incentives for interim weight loss. |
| incentives for both | Experimental | Behavioral: incentives for bothParticipants receive incentives for dietary self-monitoring and interim weight loss. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- desire to lose weight;
- agree to attend visits per protocol;
- access to telephone and transportation;
- English speaking;
- able to complete study measures;
Key exclusion criteria (14 listed)
- pregnancy, breastfeeding, or lack of birth control if premenopausal
- dementia, excessive alcohol use, or psychiatric illness
- weight loss >4.5 kg in month prior to screening
- weight > 380 lb (due to limit of cellular scale)
- enrollment in other weight loss program
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 |
|---|---|---|
| incentives for dietary self-monitoringParticipants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application. | Behavioural | incentives for dietary self-monitoring |
| incentives for interim weight lossParticipants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly. | Behavioural | incentives for interim weight loss |
| incentives for bothParticipants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly. | Behavioural | incentives for both |
Primary outcome
Weight Change From Baseline to 24 Weeks
Time frame: 24 weeks
Measured in pounds
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29289702Voils CI, Levine E, Gierisch JM, Pendergast J, Hale SL, McVay MA, Reed SD, Yancy WS Jr, Bennett G, Strawbridge EM, White AC, Shaw RJ. Study protocol for Log2Lose: A feasibility randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity. Contemp Clin Trials. 2018 Feb;65:116-122. doi: 10.1016/j.cct.2017.12.007. Epub 2017 Dec 28.
- Derived from this study: PubMed 37546286Gavin KL, Almeida EJ, Voils CI, Crane MM, Shaw R, Yancy WS Jr, Pendergast J, Olsen MK. Comparison of weight captured via electronic health record and cellular scales to the gold-standard clinical method. Obes Sci Pract. 2023 Jan 12;9(4):337-345. doi: 10.1002/osp4.656. eCollection 2023 Aug.
- Derived from this study: PubMed 33245118Voils CI, Pendergast J, Hale SL, Gierisch JM, Strawbridge EM, Levine E, McVay MA, Reed SD, Yancy WS, Shaw RJ. A randomized feasibility pilot trial of a financial incentives intervention for dietary self-monitoring and weight loss in adults with obesity. Transl Behav Med. 2021 Apr 26;11(4):954-969. doi: 10.1093/tbm/ibaa102.
- Derived from this study: PubMed 30758297Shaw R, Levine E, Streicher M, Strawbridge E, Gierisch J, Pendergast J, Hale S, Reed S, McVay M, Simmons D, Yancy W, Bennett G, Voils C. Log2Lose: Development and Lessons Learned From a Mobile Technology Weight Loss Intervention. JMIR Mhealth Uhealth. 2019 Feb 13;7(2):e11972. doi: 10.2196/11972.
- Individual participant dataSharing planned: No
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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.
Ryan J Shaw, PhD, RN principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing incentives for dietary self-monitoring, incentives for interim weight loss and incentives for both 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 7 inclusion and 14 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 Aug 2019. 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 Aug 2019). 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 From Baseline to 24 Weeks (time frame: 24 weeks). 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 NCT02691260, which also lists 4 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 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.