Impact of Group Size in Weight Loss Interventions

Obesity Clinical Trial

Official title:

Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165151
• Other study ID #: DK081607-01A1
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2010
• Last updated: March 4, 2015
• Start date: July 2010
• Est. completion date: December 2014

Study information

• Verified date: March 2015
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Behavioral:
• behavioral weight loss program
weekly, group-based lifestyle weight loss program

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in weight from baseline to month 12		12 months	No
Secondary	adherence to treatment protocol	number and proportion of treatment sessions attended	12 months	No