Clinical trial NCT02957539: Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance
Official title: Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: motivation
patient incentives
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-11-06
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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

Primary outcomes:
measure: Weight Change From Baseline to Week 32
timeFrame: 32 weeks
Secondary outcomes:
measure: Self Efficacy
timeFrame: Change form baseline to 16 weeks
measure: Self Efficacy
timeFrame: Change form baseline to 32 weeks
measure: Self Efficacy
timeFrame: Change form baseline to 52 weeks
measure: Intrinsic Motivation
timeFrame: Change form baseline to 16 weeks
measure: Intrinsic Motivation
timeFrame: Change form baseline to 32 weeks
measure: Intrinsic Motivation
timeFrame: Change form baseline to 52 weeks
measure: PHQ-8 Depression Score
timeFrame: Change from baseline to week 16
measure: PHQ-8 Depression Score
timeFrame: change from baseline to 32 weeks
measure: PHQ-8 Depression Score
timeFrame: change from baseline to 52 weeks
measure: Weight Change From Baseline
timeFrame: 16 weeks
measure: Weight Change From Baseline
timeFrame: 52 weeks
Other outcomes:
measure: Total Intervention Costs for All Participants
timeFrame: through 16 weeks
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Paul L. Hebert, PhD BA
role: PRINCIPAL_INVESTIGATOR
References: