ObesityNCT02957539
Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance
A study testing Financial rewards and Non-Financial rewards in people with Obesity, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Three of every four Veterans are overweight or obese, and weight loss is associated with reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately effective but only reaches a small percentage of overweight Veterans. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Obesity
- What is being tested?
- Financial rewards and Non-Financial rewards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2018to 30 Jul 2021
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, 98108-1532
About this study
Official title: Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance: A Randomized Controlled Trial
Three of every four Veterans are overweight or obese, and weight loss is associated with reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately effective but only reaches a small percentage of overweight Veterans. This proposed study will test whether a patient incentive program that gives Veterans non-financial incentives, such as Seattle Mariners baseball tickets, for losing one pound per week over 16 weeks is effective. An effective patient-incentive program could help more Veterans lose weight without requiring a substantial increase in VA staff.
Read the 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.
- Conditions
- Obesity
- Being tested
- Financial rewards, Non-Financial rewards
- Keywords
- motivation, patient incentives
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial rewardsBehavioural
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.
Non-Financial rewardsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| No Reward | No intervention | 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. |
| Financial Reward Arm | Experimental | 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. Receives: Behavioral: Financial rewards |
| Non-financial Reward Arm | Experimental | 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. Receives: Behavioral: Non-Financial rewards |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Change From Baseline to Week 32
The primary outcome is weight measured in pounds at week 32 minus the weight at baseline.
Measured: 32 weeks
Secondary outcomes (11)
Self Efficacy
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)
Measured: Change form baseline to 16 weeks
Self Efficacy
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).
Measured: Change form baseline to 32 weeks
Self Efficacy
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).
Measured: Change form baseline to 52 weeks
Intrinsic Motivation
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
Measured: Change form baseline to 16 weeks
Intrinsic Motivation
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
Measured: Change form baseline to 32 weeks
Intrinsic Motivation
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
Measured: Change form baseline to 52 weeks
PHQ-8 Depression Score
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.
Measured: Change from baseline to week 16
PHQ-8 Depression Score
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.
Measured: change from baseline to 32 weeks
PHQ-8 Depression Score
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.
Measured: change from baseline to 52 weeks
Weight Change From Baseline
A secondary outcome is weight measured in pounds at week 16 minus the weight at baseline.
Measured: 16 weeks
Weight Change From Baseline
A secondary outcome is weight measured in pounds at week 52 minus the weight at baseline.
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 posted7 Nov 2016 (estimated)
- Study start21 Mar 2018
- Primary completion5 Mar 2021
- Study completion30 Jul 2021
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.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 274 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Paul L. Hebert, PhD BA, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957539
- Sponsor's protocol ID
- IIR 15-459
- Status last verified
- Jul 2023
- First submitted
- 1 Nov 2016
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A corresponding data repository has been created for this project. Participants must consent to both the main project and the data repository to be included in both. Otherwise the participant will only be included in this study.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02957539
- Acronym / sponsor ID
- IIR 15-459
- Conditions
- Obesity
- Keywords
- motivation, patient incentives
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Mar 2018 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 31 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Three of every four Veterans are overweight or obese, and weight loss is associated with reduced morbidity and mortality. The VA MOVE! program for weight loss is moderately effective but only reaches a small percentage of overweight Veterans. This proposed study will test whether a patient incentive program that gives Veterans non-financial incentives, such as Seattle Mariners baseball tickets, for losing one pound per week over 16 weeks is effective. An effective patient-incentive program could help more Veterans lose weight without requiring a substantial increase in VA staff.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No Reward | No intervention | –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. |
| Financial Reward Arm | Experimental | Behavioral: Financial rewardsSame 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. |
| Non-financial Reward Arm | Experimental | Behavioral: Non-Financial rewardsProcedures 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| Financial rewardsVeterans 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. | Behavioural | Financial Reward Arm |
| Non-Financial rewardsProcedures 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. | Behavioural | Non-financial Reward Arm |
Primary outcome
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.
11 secondary outcomes
Self Efficacy
Time frame: Change form baseline to 16 weeks
Self Efficacy
Time frame: Change form baseline to 32 weeks
Self Efficacy
Time frame: Change form baseline to 52 weeks
Intrinsic Motivation
Time frame: Change form baseline to 16 weeks
Intrinsic Motivation
Time frame: Change form baseline to 32 weeks
Intrinsic Motivation
Time frame: Change form baseline to 52 weeks
PHQ-8 Depression Score
Time frame: Change from baseline to week 16
PHQ-8 Depression Score
Time frame: change from baseline to 32 weeks
PHQ-8 Depression Score
Time frame: change from baseline to 52 weeks
Weight Change From Baseline
Time frame: 16 weeks
Weight Change From Baseline
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 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A corresponding data repository has been created for this project. Participants must consent to both the main project and the data repository to be included in both. Otherwise the participant will only be included in this study.
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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.
Paul L. Hebert, PhD BA principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial rewards and Non-Financial rewards in people with Obesity, run by VA Office of Research and Development 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 28 Jul 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2023). 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 Week 32 (time frame: 32 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2023.