NCT00875199

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Mar 2009

Shorter than P25 for phase_2

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

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

November 21, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

March 31, 2009

Last Update Submit

November 17, 2011

Conditions

Keywords

OverweightObesityContingency Management

Outcome Measures

Primary Outcomes (2)

  • absolute and relative weight loss

    pre-treatment, weekly during active phase, post-treatment

  • number of participants achieving clinically significant weight loss (5% or more of baseline weight)

    pre-treatment, weekly during active phase, post-treatment

Secondary Outcomes (3)

  • retention

    during active phase

  • changes on measures of diet quality, physical activity, and self-efficacy

    pre-treatment, post-treatment

  • self-reports, focus groups

    pre-treatment, post-treatment

Study Arms (2)

A

ACTIVE COMPARATOR

Participants assigned to Group A will receive the DPP manual (Wing \& Gillis, 1996), a behavioral weight-loss program with demonstrated efficacy in facilitating weight loss. Participants in Group A 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 DPP 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

Interventions

Prize-based contingency management for weight loss

B

once weekly counseling session with research staff

A

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Danielle M Barry, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 3, 2009

Study Start

March 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

November 21, 2011

Record last verified: 2011-11

Locations