Testing Strategies to Encourage Weight Loss in an Employer Setting

Weight Loss Clinical Trial

Official title:

Testing Strategies to Encourage Weight Loss in an Employer Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01208350
• Other study ID #: 812193
• Secondary ID: RC2AG036592
• Status: Completed
• Phase: N/A
• First received: September 22, 2010
• Last updated: September 4, 2014
• Start date: March 2011
• Est. completion date: August 2014

Study information

• Verified date: September 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is a 3-arm pilot randomized controlled trial to evaluate the effectiveness of two novel ways of structuring financial incentives to motivate and sustain long-term weight loss. The study will recruit eligible employees at Children's Hospital of Philadelphia (CHOP) to participate in a 6-month weight loss program and an additional 3-month follow-up period. The primary outcome measure in this randomized control trial will be pounds of weight lost between baseline and 6 months. The goal of this study is to evaluate whether a novel financial incentive program delivered through a workplace can effectively encourage sustained weight loss among obese employees.

The study hypotheses are 1) mean weight loss will be greater in all the intervention groups compared to the control group by the end of the 24-week intervention period; and 2) individuals in the intervention groups will have a lower mean weight at the end of the 12-week follow-up period than individuals in the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 2014
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 18 to 70 (inclusive)

• BMI between 30 and 40 (inclusive)

Exclusion Criteria:

• Inability to consent

• Illiteracy and/or inability to speak, read, and write English

• Participation in another research study

• Current treatment for drug or alcohol use

• Consumption of = 5 alcoholic drinks per day

• Myocardial infarction or stroke within the past 6 months

• Current addiction to prescription medicines or street drugs

• Serious psychiatric diagnoses (e.g., severe major depressive disorder, bipolar disorder, schizophrenia)

• Pregnant or currently breastfeeding

• Diabetic and using any medicine besides metformin to control blood glucose

• Metastatic cancer

• Unstable medical conditions that would likely prevent the subject from completing the study

• Previous diagnosis of an eating disorder

• History of unsafe weight loss behaviors such as binging or the use of laxatives

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Weight Loss

Intervention

Behavioral:
• No intervention
Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months
• Group-based payout
Monthly weigh-ins for 6 months where five sequential participants, randomized to this condition, will be joined into virtual groups where individual rewards for weight loss are dependent on the weight loss of others in the group, with follow-up weigh in at 9 months
• Individual payout
Monthly weigh-ins for 6 months and if monthly goals are met, participants receive payout at the end of the month, with follow-up weigh-in at 9 months

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (5)

Lead Sponsor	Collaborator
University of Pennsylvania	Children's Hospital of Philadelphia, incentaHEALTH, National Institute on Aging (NIA), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight between baseline and six months		24 weeks	No
Secondary	usability of a newly developed web portal and its feasibility for future randomized clinical trials aimed at changing health-related behaviors		end of study	No