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Impact of Group Size in Weight Loss Interventions

Primary Purpose

Obesity, Weight Loss

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
behavioral weight loss program
Sponsored by
Florida State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, weight loss, group size

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Florida State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Small group

Large group

Arm Description

10-member groups

30-member groups

Outcomes

Primary Outcome Measures

change in weight from baseline to month 12

Secondary Outcome Measures

adherence to treatment protocol
number and proportion of treatment sessions attended

Full Information

First Posted
July 16, 2010
Last Updated
March 4, 2015
Sponsor
Florida State University
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1. Study Identification

Unique Protocol Identification Number
NCT01165151
Brief Title
Impact of Group Size in Weight Loss Interventions
Official Title
Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Florida State University

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Weight Loss
Keywords
obesity, weight loss, group size

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Small group
Arm Type
Experimental
Arm Description
10-member groups
Arm Title
Large group
Arm Type
Active Comparator
Arm Description
30-member groups
Intervention Type
Behavioral
Intervention Name(s)
behavioral weight loss program
Intervention Description
weekly, group-based lifestyle weight loss program
Primary Outcome Measure Information:
Title
change in weight from baseline to month 12
Time Frame
12 months
Secondary Outcome Measure Information:
Title
adherence to treatment protocol
Description
number and proportion of treatment sessions attended
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States

12. IPD Sharing Statement

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Impact of Group Size in Weight Loss Interventions

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