N/A
N=344
The Healthy Weigh Study
Obesity
Bottom Line
View on ClinicalTrials.gov: NCT02878343 ↗Enrolled (actual)
344
Serious AEs
1.5%
Results posted
Oct 2024
Primary outcome: Primary: Mean Weight Change — -6.86; -6.86; -2.82; -0.66 pounds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Incentives (Behavioral); Environmental strategies (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Weight Change |
-6.86; -6.86; -2.82; -0.66 | — |
Summary
This study will evaluate the comparative effectiveness of behavioral economic financial incentives and environmental strategies, separately and together, in achieving initial weight loss and maintenance of weight loss, in obese employee populations. Our study contributes to the Centers for Disease Control and Prevention's efforts to combat obesity but in particular to the Centers for Disease Control's winnable battles (physical activity and obesity); the National Center for Chronic Disease Prevention and Health Promotion's strategic priorities around well-being, health equity, and evaluation and dissemination of environmental and systems-wide solutions to address public health problems; and the National Center for Chronic Disease Prevention and Health Promotion's domain around healthier work-site initiatives, the Centers for Disease Control and Prevention's efforts to improve nutrition and physical activity to prevent obesity, and reduction of cardiovascular disease risk. This study is a 4-arm randomized controlled trial in which 344 employees of the City of Philadelphia, Independence Blue Cross, and South Eastern Pennsylvania Transportation Authority with initial Body Mass Index of 30 will be randomized to receive one of the following: 1) Daily lottery type incentives tied to achievement of weight loss goals (incentive arm); 2) individually tailored environmental strategies around food intake and physical activity (environmental arm); 3) a combination of incentives and environmental strategies (combined arm); or 4) standard employee wellness benefits and weigh-ins every 6 months (control arm). Phase I of the study (first 6 months) will focus on weight loss; Phase II (months 7-18) will focus on continued weight loss or maintenance for those who choose to maintain weight loss as opposed to continuing to try to lose weight; Phase III (months 19-24) will provide a period of post-intervention follow-up to measure sustainability of effects.
Eligibility Criteria
Inclusion Criteria
- Men and women > 18 yrs. of age
- Full-time or part-time employees at Southeastern Pennsylvania Transportation Authority , Independence Blue Cross, or the City of Philadelphia
- BMI of 30 to 55 kg/m2
- Participants must receive their health benefits from Independence Blue Cross; one of our partners in the study
Exclusion Criteria
- Unstable heart disease, uncontrolled hypertension, kidney disease, and other serious chronic illness (e.g., transplant recipient, terminal illness)
- Substance abuse; bulimia nervosa or related behaviors; or diabetes medication other than metformin
- Pregnancy or breast feeding
- Contraindications to counseling about diet, physical activity, or weight reduction
- Unstable mental illness
- Individuals unable to read consent forms or fill out surveys in English will be excluded.
Data sourced from ClinicalTrials.gov (NCT02878343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.