Impact of Group Size in Weight Loss Interventions

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Florida State University
ClinicalTrials.gov Identifier:
NCT01165151
First received: July 16, 2010
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Obesity
Weight Loss
Behavioral: behavioral weight loss program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment

Resource links provided by NLM:


Further study details as provided by Florida State University:

Primary Outcome Measures:
  • change in weight from baseline to month 12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adherence to treatment protocol [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    number and proportion of treatment sessions attended


Estimated Enrollment: 70
Study Start Date: July 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
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: NCT01165151

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

No publications provided

Responsible Party: Florida State University
ClinicalTrials.gov Identifier: NCT01165151     History of Changes
Other Study ID Numbers: DK081607-01A1
Study First Received: July 16, 2010
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Florida State University:
obesity
weight loss
group size

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

ClinicalTrials.gov processed this record on July 24, 2014