A Behavioral Intervention for Reducing Obesity
2 other identifiers
interventional
56
1 country
1
Brief Summary
This study will examine a contingency management (CM) intervention designed to provide incentives for losing weight versus participating in a manual-guided behavioral weight loss intervention alone. Participants in the CM condition will earn the opportunity to win prizes by losing weight and completing activities that contribute to weight loss, such as keeping daily food and physical activity diaries, choosing healthy foods, exercising, and using other weight loss strategies. The investigators will determine if the CM improves weight loss relative to the usual care manual-guided intervention alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 3, 2009
CompletedFirst Posted
Study publicly available on registry
May 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2010
CompletedApril 9, 2019
April 1, 2019
1.2 years
April 3, 2009
April 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
absolute and relative weight loss
Weeks 1-12
changes in waist circumference
Week 1 and Week 12
proportion of participants achieving clinically significant weight loss (5% or more of baseline weight)
Week 1 and Week 12
Secondary Outcomes (2)
indices of treatment retention
Weeks 1-12
changes on measures of diet quality, physical activity, and physiological parameters such as blood pressure, lipoproteins, insulin, and glucose levels
Week 1 and Week 12
Study Arms (2)
A
ACTIVE COMPARATORParticipants assigned to Group A will receive the LEARN (Lifestyle, Exercise, Attitudes, Relationships, Nutrition) Program weight loss manual and will be instructed to read a section of the manual each week and complete suggested activities. They will also meet with the research staff once a week for weigh-in and supportive counseling.
B
EXPERIMENTALParticipants assigned to Group B will receive the LEARN manual and will meet with research staff each week for weigh-in and supportive counseling. They will also receive contingency management or the opportunity to earn draws with the chance of winning prizes for losing weight and completing healthy activities.
Interventions
once weekly counseling sessions with research staff
Eligibility Criteria
You may qualify if:
- age between 18 and 65 years
- body mass index in kg/m2 (BMI) between 30.0 and 39.9
- seated blood pressure of 100/60-140/90 mmHg
- ability to speak English and read at the 6th grade level
- willingness to be randomly assigned to one of two groups
You may not qualify if:
- any serious acute or chronic medical problems that may impact dietary or exercise regimens or impact weight loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- UConn Healthlead
- UCHC/Storrs and Regional Campus Incentive Grantscollaborator
Study Sites (1)
University of Connecticut Health Center
Farmington, Connecticut, 06030-3944, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy M Petry, Ph.D.
UConn Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2009
First Posted
May 5, 2009
Study Start
April 1, 2009
Primary Completion
July 1, 2010
Study Completion
July 1, 2010
Last Updated
April 9, 2019
Record last verified: 2019-04