Comparison of Weight Management Programs Delivered in Large Versus Small Groups

January 10, 2024 updated by: Gareth R. Dutton PhD, University of Alabama at Birmingham
The purpose of this study is to compare the 6- and 12-month weight changes associated with lifestyle interventions delivered in a large group or small groups of participants. It is hypothesized that participants receiving treatment in a small group will have greater weight loss than those assigned to a larger group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • University of Alabama at Birmingham
    • Florida
      • Tallahassee, Florida, United States, 32309
        • Florida State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • at least 21 years-old
  • body mass index (BMI) between 30-45

Exclusion Criteria:

  • have lost >4.5 kg in past six months
  • have medical condition(s) likely to affect ability to participate in physical activity
  • planning to relocate from the area in next 12 months
  • unable or unwilling to attend weekly group sessions
  • unwilling to accept random assignment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: small group treatment
lifestyle intervention for obesity delivered to small groups of approximately 12 participants/group
Behavioral: lifestyle intervention for obesity
Active Comparator: large group treatment
lifestyle intervention for obesity delivered to a large group of approximately 30 participants
Behavioral: lifestyle intervention for obesity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in body weight from baseline to months 6 and 12
Time Frame: baseline, month 6, month 12
Weight will be measured to the nearest 0.1 kg using calibrated digital scales at baseline, month 6, and month 12.
baseline, month 6, month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment attendance
Time Frame: 12 months
Participants attendance at each treatment group session was recorded.
12 months
treatment adherence
Time Frame: 12 months
Participants' self-monitoring of food intake was collected to determine adherence to this component of treatment.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alabama at Birmingham

Investigators

  • Principal Investigator: Gareth Dutton, PhD, University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimated)

March 17, 2014

Study Record Updates

Last Update Posted (Estimated)

January 11, 2024

Last Update Submitted That Met QC Criteria

January 10, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DK081607-pilot
  • K23DK081607 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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