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Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02957539
Recruitment Status : Enrolling by invitation
First Posted : November 6, 2016
Last Update Posted : November 14, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obesity Behavioral: Financial rewards Behavioral: Non-Financial rewards Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance: A Randomized Controlled Trial
Actual Study Start Date : March 21, 2018
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 29, 2021

Resource links provided by the National Library of Medicine


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.
Behavioral: Financial rewards
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.
Behavioral: Non-Financial rewards
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.




Primary Outcome Measures :
  1. Weight change from baseline [ Time Frame: 32 weeks ]
    The primary outcome is weight measured in pounds at week 32 minus the weight at baseline.


Secondary Outcome Measures :
  1. Food insecurity [ Time Frame: 16 weeks, 32 weeks, and 12 months ]
    Measured by patient survey responses to the food security questions used in the National Health Interview Survey

  2. Self efficacy [ Time Frame: 16 weeks, 32 weeks, and 12 months ]
    Measured by survey responses to the Weight Efficacy Lifestyle Questionnaire Short Form (WEL-SF)

  3. weight loss behaviors [ Time Frame: 16 weeks, 32 weeks, and 12 months ]
    Measured by patient survey responses to the weight loss strategies questions in the National Health And Nutrition Examination Survey

  4. Eating behaviors [ Time Frame: 16 weeks, 32 weeks, and 12 months ]
    Measured by patient survey responses to the Three Factor Eating Questionnaire

  5. Physical activity [ Time Frame: 16 weeks, 32 weeks, and 12 months ]
    Measured by patient survey responses to the International Physical Activity questionnaire

  6. Intrinsic/extrinsic motivation [ Time Frame: 16 weeks, 32 weeks, and 12 months ]
    Measured by patient survey responses to the Regulation of Eating Behavior Scale

  7. Mental health [ Time Frame: 16 weeks, 32 weeks, and 12 months ]
    Measured by patient survey responses to the Personal Health Questionnaire Depression Scale (PHQ-8)


Other Outcome Measures:
  1. Intervention costs [ Time Frame: through 32 weeks ]
    The investigators will collect data on the cost of the intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957539


Locations
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United States, Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington, United States, 98108
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Paul L. Hebert, PhD BA VA Puget Sound Health Care System Seattle Division, Seattle, WA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02957539    
Other Study ID Numbers: IIR 15-459
First Posted: November 6, 2016    Key Record Dates
Last Update Posted: November 14, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
motivation
patient incentives
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight
Signs and Symptoms