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Impact of Group Size in Weight Loss Interventions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01165151
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The present study will assess whether the size of treatment groups (groups of 10 vs. 30 participants) affects short- and long-term weight loss. It is hypothesized that participants assigned to a small group will exhibit similar short-term and long-term weight losses (i.e., weight loss at months 6 and 12) as compared to those assigned to a large group.

Condition or disease Intervention/treatment Phase
Obesity Weight Loss Behavioral: behavioral weight loss program Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment
Study Start Date : July 2010
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Small group
10-member groups
Behavioral: behavioral weight loss program
weekly, group-based lifestyle weight loss program
Active Comparator: Large group
30-member groups
Behavioral: behavioral weight loss program
weekly, group-based lifestyle weight loss program

Outcome Measures

Primary Outcome Measures :
  1. change in weight from baseline to month 12 [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. adherence to treatment protocol [ Time Frame: 12 months ]
    number and proportion of treatment sessions attended

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Adults (at least 21 years-old)
  • Health insurance coverage with Capital Health Plan (CHP)
  • Body mass index BMI between 30-45 kg/m2

Exclusion Criteria:

  • BMI is less than 30 kg/m2 or greater than 45 kg/m2
  • Weight loss > 10 pounds in past 6 months
  • Acute or chronic illnesses for which weight loss is contraindicated
  • Unwilling or unable to give informed consent
  • Unwilling to accept random assignment
  • Unwilling or unable to travel to CHP clinic for assessments and groups
  • Likely to relocate out of the area in the next 12 months
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01165151

United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
Sponsors and Collaborators
Florida State University
More Information

Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT01165151     History of Changes
Other Study ID Numbers: DK081607-01A1
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Keywords provided by Florida State University:
weight loss
group size

Additional relevant MeSH terms:
Body Weight
Weight Loss
Signs and Symptoms
Body Weight Changes