- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02957539
Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance
Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Project Background: Behavioral economics suggests that the chronic inability to make the daily behavioral changes that can help us lose weight may be the result of "present bias," which is a tendency to value small, immediate rewards over large rewards in the distant future. For many of us, the immediate gratification of eating an unhealthy food is a more powerful motivator than is the elusive dissatisfaction of the long-run health consequences of an unhealthy diet. Patient rewards may overcome present bias by moving the rewards for healthy behaviors forward in time. In a patient reward program, patients are given tangible, timely rewards for achieving specific health goals, such as losing one pound per week over 16 weeks. Meta analyses of randomized trials have found that rewards for weight loss are effective during the reward period, but the weight loss was not sustained after the reward was removed. Thus, the key challenge to a reward program is not achieving weight loss, but maintaining it. The proposed study tests the hypothesis that the significant weight regain found in prior reward trials can be attributed to use of financial rewards-e.g., cash or the equivalent of cash-in those trials. Experiments in behavioral economics have found that providing participants with financial rewards for participating in a study invokes behavior defined by reciprocity-the effort the participants gave in the study was proportional to the amount of money that they were given. When participants were given non-financial rewards, they exhibited no reciprocity-the effort was consistently high and did not vary with the quantity of the non-financial reward. By using financial rewards, prior trials may have invoked money-market norms of reciprocity, such that patients' efforts toward weight loss were high when rewards were offered, and reduced when they were discontinued. The investigators hypothesize that non-financial rewards, like tickets to a Seattle Mariners baseball game, will not invoke reciprocity or the consequent weight regain.
Project Objectives: The goal of this study is to test, through a randomized trial, the effectiveness of providing overweight Veterans with financial or non-financial rewards for a one pound weight loss per week over 16 weeks. The primary outcome is weight loss at 32 weeks-16 weeks after the discontinuation of the rewards. Secondary outcomes include weight loss at 16 weeks and 12 months.
Project Methods: The investigators will conduct a three-armed randomized trial of patient rewards for losing one pound per week over 16 weeks. The three treatment groups will receive financial rewards, non-financial rewards, or no rewards. The investigators hypothesize that: 1) patients who receive non-financial rewards for weight loss over 16 weeks will have greater weight loss at 32 weeks than patients who do not receive rewards; 2) patients who receive non-financial rewards for weight loss over 16 weeks will experience weight loss at 16 weeks that is not inferior to the weight loss of patients who receive financial rewards; and 3) weight regain will be greater among patients who received financial rewards compared to patients who received non-financial rewards or no rewards. The investigators will also conduct post-intervention qualitative interviews and perform a cost analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98108-1532
- VA Puget Sound Health Care System Seattle Division, Seattle, WA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Veteran
- BMI>=30 at enrollment
- weigh less than 390lbs
- Active patient in primary care or women's clinic (1+ visit in last year)
- Access to a text capable phone in the Veteran's household or active email address
- live in Seattle area the entire year
- access to the internet
Exclusion Criteria:
- behavioral flag
- serious mental illness or anti-psychotic medication
- eating disorder and/or sexual trauma
- MOVE! participation in past 4 months
- pregnant or planning to become pregnant
- prisoner/employee/student
- inability to independently stand
- inability to read
- insulin dependent
- impaired decision making
- no access to a cell phone or phone that can receive text messages
- inability to remove socks & shoes
- >5% of body weight lost in last 6 months (clinical data and self-report)
- unable to pass cognitive screening
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: No Reward
At enrollment, participants randomized to usual care will be given the MOVE! workbook that serves both as an information resource on diet and exercise, a resource for tools to achieve weight loss goals, and a log of participants' goals, motivations, and outcomes.
Each participant will be given a chart with a personalized target weight for a loss of 1lb.
per week for 16 weeks.
Participants will be given a digital scale or wireless scale and counseled to weigh themselves daily.
Participants will enter their weight weekly into an online portal.
They will also complete the surveys in the portal.
They will receive text message reminders to enter their weight.
|
|
|
Experimental: Financial Reward Arm
Same as usual care, plus financial rewards that are earned in two ways: an assured and random.
For the assured reward, they will receive compensation at the end of each month that they are at or below their target weight on the last day of that period.
For the random portion, each week that a participant is at or below their target weight, the patient is entered in random drawing to win additional compensation.
Over the first eight weeks the patient has a 1-in-8 chance of winning.Over the 17-32 week period, Veterans in this group will receive token rewards for tracking and reporting their weekly weights regardless of whether it was on target.
Each week that the patient enters his/her weight into the portal, he will have a 1-in-8 chance to earn the token reward, such as a t-shirt or movie tickets.
Participants will enter their weight weekly into an online portal.
They will also complete the surveys in the portal.
They will receive text message reminders to enter their weight.
|
Veterans in the financial reward arm receive all of the services of the usual care arm, plus rewards that are earned in two ways: an assured portion, and a random portion.
For the assured reward, they will receive compensation at the end of each month (defined as a four week period) that they are at or below their target weight.
For the random portion, each week that a participant is at or below their target weight, the patient is entered into a drawing to win additional compensation.
Over the first eight weeks the patient has a 1-in-8 chance of winning.
Over the 17-32 week period, Veterans in this group will receive token incentives for tracking and reporting their weekly weights regardless of whether it was on target.
Each week that the patient enters their weight into the portal, s/he will have a 1-in-8 chance to earn the token incentive, such as a t-shirt or movie ticket.
The participant will receive reminder text messages.
|
|
Experimental: Non-financial Reward Arm
Procedures for the non-financial rewards arm is identical to procedures for the financial reward arm, except that the Veteran will earn points rather than cash.
Each week a random drawing will be for 20 points, each monthly weigh in is worth 5 points.
Veterans will be given non-financial rewards associated with the number of points they earn.
|
Procedures for the non-financial rewards arm are identical to procedures for the financial reward arm, except that the Veteran will earn points rather than cash.
Each weekly random drawing will be for 20 points.
Veterans will choose non-financial rewards associated with the number of points they earn.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Weight Change From Baseline to Week 32
Time Frame: 32 weeks
|
The primary outcome is weight measured in pounds at week 32 minus the weight at baseline.
|
32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self Efficacy
Time Frame: Change form baseline to 16 weeks
|
Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident).
Higher scores mean better outcomes.
Missing values at follow-up were imputed using multiple imputation by chained equations (MICE)
|
Change form baseline to 16 weeks
|
|
Self Efficacy
Time Frame: Change form baseline to 32 weeks
|
Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident).
|
Change form baseline to 32 weeks
|
|
Self Efficacy
Time Frame: Change form baseline to 52 weeks
|
Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF).Scale goes from 0 (not at all confident) to 10 (very confident).
|
Change form baseline to 52 weeks
|
|
Intrinsic Motivation
Time Frame: Change form baseline to 16 weeks
|
Measured by patient survey responses to the Regulation of Eating Behavior Scale.
Scale from 1 (does not agree at all) to 7 (agrees exactly).
Higher values represent greater intrinsic motivation
|
Change form baseline to 16 weeks
|
|
Intrinsic Motivation
Time Frame: Change form baseline to 32 weeks
|
Measured by patient survey responses to the Regulation of Eating Behavior Scale.
Scale from 1 (does not agree at all) to 7 (agrees exactly).
Higher values represent greater intrinsic motivation
|
Change form baseline to 32 weeks
|
|
Intrinsic Motivation
Time Frame: Change form baseline to 52 weeks
|
Measured by patient survey responses to the Regulation of Eating Behavior Scale.
Scale from 1 (does not agree at all) to 7 (agrees exactly).
Higher values represent greater intrinsic motivation
|
Change form baseline to 52 weeks
|
|
PHQ-8 Depression Score
Time Frame: Change from baseline to week 16
|
Measured by patient survey responses to the Personal Health Questionnaire Depression Scale (PHQ-8).
The scale ranges from 0 to 24.
Higher scores mean more severe depression.
|
Change from baseline to week 16
|
|
PHQ-8 Depression Score
Time Frame: change from baseline to 32 weeks
|
Measured by patient survey responses to the Personal Health Questionnaire Depression Scale (PHQ-8).
The scale has the following options: not at all, several days, more than half the days, nearly every day.
Scores range from 0 to 24.
Higher scores represent more severe depression.
|
change from baseline to 32 weeks
|
|
PHQ-8 Depression Score
Time Frame: change from baseline to 52 weeks
|
Measured by patient survey responses to the Personal Health Questionnaire Depression Scale (PHQ-8).
Measured by patient survey responses to the Personal Health Questionnaire Depression Scale (PHQ-8).
The scale ranges from 0 to 24.
Higher scores mean more severe depression.
|
change from baseline to 52 weeks
|
|
Weight Change From Baseline
Time Frame: 16 weeks
|
A secondary outcome is weight measured in pounds at week 16 minus the weight at baseline.
|
16 weeks
|
|
Weight Change From Baseline
Time Frame: 52 weeks
|
A secondary outcome is weight measured in pounds at week 52 minus the weight at baseline.
|
52 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Intervention Costs for All Participants
Time Frame: through 16 weeks
|
The investigators will collect data on the cost of the intervention.
|
through 16 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Paul L. Hebert, PhD BA, VA Puget Sound Health Care System Seattle Division, Seattle, WA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 15-459
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | Obesity and Obesity-related Medical ConditionsUnited States
-
Central Hospital, Nancy, FranceNot yet recruiting
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Dr. Christopher McGowanRecruitingObesity Prevention | Obesity Recidivism | Obesity and Overweight | GLP-1 | Obesity and Obesity-related Medical Conditions | Ablation TechniquesUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
Clinical Trials on Financial rewards
-
Mayo ClinicNational Institute on Drug Abuse (NIDA); Alaska Native Tribal Health ConsortiumRecruitingSmoking CessationUnited States
-
University of California, DavisEunice Kennedy Shriver National Institute of Child Health and Human Development...RecruitingPerformance vs. Effort RewardsUnited States
-
University of Alabama at BirminghamCompletedDisability Physical | Chronic Conditions, Multiple | Chronic ConditionUnited States
-
University of PennsylvaniaDiscovery VitalityWithdrawnPhysical ActivityUnited States
-
University of PennsylvaniaNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedTobacco Use DisorderUnited States
-
University of MichiganCompletedPhysical ActivityUnited States
-
Albert Einstein Healthcare NetworkRobert Wood Johnson FoundationCompletedFocus of the Study is on the Use of Incentives to Promote | Healthier Eating in Low-income CommunitiesUnited States
-
Duke-NUS Graduate Medical SchoolSingapore General Hospital; Changi General Hospital; National Medical Research... and other collaboratorsCompleted
-
University of South CarolinaNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
Christina StudtsUniversity of VermontCompletedParenting | Disruptive Behavior DisorderUnited States