NCT00892788

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2009

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

April 9, 2019

Status Verified

April 1, 2019

Enrollment Period

1.2 years

First QC Date

April 3, 2009

Last Update Submit

April 5, 2019

Conditions

Keywords

OverweightObesityContingency Management

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 COMPARATOR

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

B

EXPERIMENTAL

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 managementBehavioral: weight loss manual-guided individual therapy sessions

Interventions

Prize-based contingency management for weight loss

B

once weekly counseling sessions with research staff

AB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030-3944, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nancy M Petry, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

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

Locations