Obesity Clinical Trial
Official title:
Financial vs. Non-Financial Rewards for Weight Loss and Weight Maintenance: A Randomized Controlled Trial
NCT number | NCT02957539 |
Other study ID # | IIR 15-459 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 21, 2018 |
Est. completion date | July 30, 2021 |
Verified date | July 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 274 |
Est. completion date | July 30, 2021 |
Est. primary completion date | March 5, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 69 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | VA Puget Sound Health Care System Seattle Division, Seattle, WA | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Total Intervention Costs for All Participants | The investigators will collect data on the cost of the intervention. | through 16 weeks | |
Primary | Weight Change From Baseline to Week 32 | The primary outcome is weight measured in pounds at week 32 minus the weight at baseline. | 32 weeks | |
Secondary | 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) | Change form baseline to 16 weeks | |
Secondary | 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). | Change form baseline to 32 weeks | |
Secondary | 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). | Change form baseline to 52 weeks | |
Secondary | 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 | Change form baseline to 16 weeks | |
Secondary | 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 | Change form baseline to 32 weeks | |
Secondary | 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 | Change form baseline to 52 weeks | |
Secondary | 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. | Change from baseline to week 16 | |
Secondary | 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. | change from baseline to 32 weeks | |
Secondary | 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. | change from baseline to 52 weeks | |
Secondary | Weight Change From Baseline | A secondary outcome is weight measured in pounds at week 16 minus the weight at baseline. | 16 weeks | |
Secondary | Weight Change From Baseline | A secondary outcome is weight measured in pounds at week 52 minus the weight at baseline. | 52 weeks |
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