- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00606840
Weight Gain Prevention
April 12, 2012 updated by: Jessica LaRose, The Miriam Hospital
Study to Prevent Weight Gain
The specific aim of the proposed project is to test two separate self-regulation interventions to prevent weight gain in young adults, one based on making sustained small changes in behavior to prevent weight gain and the other on making periodic larger behavior changes resulting in weight loss.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
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
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Providence, Rhode Island, United States, 02903
- The Miriam Hospital
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-
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
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18-35
- Body mass index between 23 and 30
- Interested in preventing weight gain
Exclusion Criteria:
- BMI outside of range specified
- Age outside of range specified
- History of or current eating disorder or substance abuse
- Recent weight loss greater than 5% of weight
- Currently in another research study that would interfere
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: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
One arm is a large changes group in which participants will be asked to make periodic large changes in their eating and activity, aimed at producing initial weight loss, in order to prevent weight gain over time.
|
Behavioral self-regulation interventions to prevent weight gain in young adults.
|
Experimental: 2
The second arm is a small changes group in which participants will be asked to make small changes to their eating and activity and maintain these changes forever in order to prevent weight gain.
|
Behavioral self-regulation interventions to prevent weight gain in young adults.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight change
Time Frame: 8 weeks and 16 weeks
|
8 weeks and 16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
frequency of weighing, adherence to intervention, diet, activity
Time Frame: 8 weeks and 16 weeks
|
8 weeks and 16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rena R Wing, Ph.D., The Miriam Hospital
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
January 1, 2008
Primary Completion (Actual)
September 1, 2008
Study Completion (Actual)
September 1, 2008
Study Registration Dates
First Submitted
January 22, 2008
First Submitted That Met QC Criteria
February 4, 2008
First Posted (Estimate)
February 5, 2008
Study Record Updates
Last Update Posted (Estimate)
April 13, 2012
Last Update Submitted That Met QC Criteria
April 12, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- #2018-07
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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