- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01165151
Impact of Group Size in Weight Loss Interventions
March 4, 2015 updated by: Florida State University
Improving Weight Loss Maintenance Through Alternatives Schedules of Treatment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
70
Phase
- Phase 4
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
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- 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
Genders Eligible for Study
All
Description
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 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
10-member groups
|
weekly, group-based lifestyle weight loss program
|
Active Comparator: Large group
30-member groups
|
weekly, group-based lifestyle weight loss program
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
change in weight from baseline to month 12
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adherence to treatment protocol
Time Frame: 12 months
|
number and proportion of treatment sessions attended
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2010
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
July 16, 2010
First Submitted That Met QC Criteria
July 16, 2010
First Posted (Estimate)
July 19, 2010
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
March 4, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DK081607-01A1
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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