A Behavioral Intervention for Reducing Obesity

This study has been completed.
Sponsor:
Collaborator:
UCHC/Storrs and Regional Campus Incentive Grants
Information provided by (Responsible Party):
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00892788
First received: April 3, 2009
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Overweight
Obesity
Behavioral: contingency management
Behavioral: weight loss manual-guided individual therapy sessions
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Behavioral Intervention for Reducing Obesity

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

Primary Outcome Measures:
  • absolute and relative weight loss [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
  • changes in waist circumference [ Time Frame: Week 1 and Week 12 ] [ Designated as safety issue: No ]
  • proportion of participants achieving clinically significant weight loss (5% or more of baseline weight) [ Time Frame: Week 1 and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • indices of treatment retention [ Time Frame: Weeks 1-12 ] [ Designated as safety issue: No ]
  • changes on measures of diet quality, physical activity, and physiological parameters such as blood pressure, lipoproteins, insulin, and glucose levels [ Time Frame: Week 1 and Week 12 ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: April 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Participants 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.
Behavioral: weight loss manual-guided individual therapy sessions
once weekly counseling sessions with research staff
Experimental: B
Participants 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.
Behavioral: contingency management
Prize-based contingency management for weight loss
Behavioral: weight loss manual-guided individual therapy sessions
once weekly counseling sessions with research staff

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • any serious acute or chronic medical problems that may impact dietary or exercise regimens or impact weight loss
  • psychiatric exclusions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892788

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-3944
Sponsors and Collaborators
University of Connecticut Health Center
UCHC/Storrs and Regional Campus Incentive Grants
Investigators
Principal Investigator: Nancy M Petry, Ph.D. University of Connecticut Health Center
  More Information

No publications provided

Responsible Party: University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00892788     History of Changes
Other Study ID Numbers: 09-128-1, 20090200
Study First Received: April 3, 2009
Last Updated: November 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Connecticut Health Center:
Overweight
Obesity
Contingency Management

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on September 22, 2014