Contingency Management to Promote Weight Loss in Low Income Adults

Overweight Clinical Trial

Official title:

Contingency Management to Promote Weight Loss in Low Income Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00875199
• Other study ID #: 09-108-2
• Secondary ID: 20090009
• Status: Completed
• Phase: Phase 2
• First received: March 31, 2009
• Last updated: November 17, 2011
• Start date: March 2009
• Est. completion date: March 2010

Study information

• Verified date: November 2011
• Source: University of Connecticut Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study is designed to evaluate the feasibility and provide preliminary evidence for efficacy of a 12-week contingency management intervention to promote weight loss in overweight and obese low income adults in a community-based clinic. The study has three primary goals: (a) to determine if the contingency management treatment can be effectively applied to a new application, weight loss; (b) to obtain preliminary evidence for contingency management's efficacy in promoting weight loss and improving treatment retention, diet quality, physical activity levels, and self efficacy; and (c) to identify barriers and challenges to implementing contingency management for weight loss among low income patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• age between 18 and 55 years

• body mass index in kg/m2 (BMI) between 25 and 39.9

• resting blood pressure between 90/60 and 140/90

• ability to speak English and read at the 6th grade level

• willingness to be randomly assigned to one of two groups

Exclusion Criteria:

• any serious acute or chronic medical problems that may impact dietary or exercise regimens

• psychiatric conditions

Study Design

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

Related Conditions & MeSH terms

• Overweight

Intervention

Behavioral:
• contingency management
Prize-based contingency management for weight loss
• weight loss manual-guided individual therapy sessions
once weekly counseling session with research staff

Locations

Country	Name	City	State
United States	University of Connecticut Health Center	Farmington	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
University of Connecticut Health Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absolute and relative weight loss		pre-treatment, weekly during active phase, post-treatment	No
Primary	number of participants achieving clinically significant weight loss (5% or more of baseline weight)		pre-treatment, weekly during active phase, post-treatment	No
Secondary	retention		during active phase	No
Secondary	changes on measures of diet quality, physical activity, and self-efficacy		pre-treatment, post-treatment	No
Secondary	self-reports, focus groups		pre-treatment, post-treatment	No