- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00716027
Applying Social Comparison Theory to Behavioral Weight Loss: Does Modifying Group Membership Improve Outcome?
September 28, 2010 updated by: The Miriam Hospital
The purpose of this study is to determine whether a modified behavioral treatment for weight loss that includes one-on-one treatment for individuals struggling to lose weight is associated with more weight loss than a standard behavioral treatment.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
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
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- The Miriam Hospital
-
-
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 to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- BMI between 27 and 45 kg/m2
Exclusion Criteria:
- participating in a weight loss program or taking a weight loss medication
- currently pregnant, lactating, or less than 6-months post-partum or plan to become pregnant during the time of the intervention.
- report a heart condition, chest pain during periods of activity or rest, or loss of consciousness
- report conditions that would render the participant unlikely to follow the study protocol (e.g., terminal illness, relocation, substance abuse, sever psychiatric condition, dementia).
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 |
---|---|
Active Comparator: 1
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
|
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
|
Experimental: 2
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.
|
A 24-week intervention in which individuals will meet weekly to be instructed on behavioral change associated with weight loss, including modifying dietary intake, self-monitoring weight and eating behaviors, and increasing physical activity.
In this intervention, individuals not meeting weight loss goals will be given one-on-one treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight
Time Frame: weekly for 24-weeks
|
weekly for 24-weeks
|
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, 2008
Primary Completion (Actual)
December 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
July 15, 2008
First Submitted That Met QC Criteria
July 15, 2008
First Posted (Estimate)
July 16, 2008
Study Record Updates
Last Update Posted (Estimate)
September 29, 2010
Last Update Submitted That Met QC Criteria
September 28, 2010
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2034-08
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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