The Healthy Weigh Study

NCT02878343 | Completed Results DMC

• 1 other identifier: 821428
• Study Type: interventional
• Target: 344
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Mean Weight Change

  Change in mean weight (lbs.) from baseline to 18 months

  Baseline to 18 months

Study Arms (4)

Incentives

ACTIVE COMPARATOR

Daily lottery type incentives tied to achievement of weight loss goals

Behavioral: Incentives

Environmental strategies

ACTIVE COMPARATOR

Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform

Behavioral: Environmental strategies

Incentive and environmental strategies

ACTIVE COMPARATOR

A combination of incentives and environmental strategies

Behavioral: Incentives; Behavioral: Environmental strategies

Usual care

NO INTERVENTION

Standard employee wellness benefits

Interventions

Incentives BEHAVIORAL

Daily lottery type incentives tied to achievement of weight loss goals

Incentive and environmental strategies; Incentives

Environmental strategies BEHAVIORAL

Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform

Environmental strategies; Incentive and environmental strategies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Centers for Disease Control and Prevention: collaborator

Related Publications (2)

• Glanz K, Kather C, Chung A, Choi JR, Volpp KG, Clapp J. Qualitative study of perceptions of factors contributing to success or failure among participants in a US weight loss trial of financial incentives and environmental change strategies. BMJ Open. 2024 Mar 29;14(3):e078111. doi: 10.1136/bmjopen-2023-078111.

  PMID: 38553057 DERIVED

• Glanz K, Shaw PA, Kwong PL, Choi JR, Chung A, Zhu J, Huang QE, Hoffer K, Volpp KG. Effect of Financial Incentives and Environmental Strategies on Weight Loss in the Healthy Weigh Study: A Randomized Clinical Trial. JAMA Netw Open. 2021 Sep 1;4(9):e2124132. doi: 10.1001/jamanetworkopen.2021.24132.

  PMID: 34491350 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Fertility

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Results Point of Contact

• Title: Dr. Karen Glanz
• Organization: UPenn

kglanz@pennmedicine.upenn.edu

Study Officials

• Kevin Volpp, MD, PhD

  The University of Pennsylvania

  PRINCIPAL INVESTIGATOR

• Karen Glanz, PhD, MPH

  The University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2016
• First Posted: August 25, 2016
• Study Start: April 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: May 1, 2018
• Last Updated: October 23, 2024
• Results First Posted: October 23, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share