- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00488228
Behavioral Self-Regulation
April 12, 2012 updated by: The Miriam Hospital
Behavioral Self-Regulation for Weight Loss in Young Adults
The purpose of this pilot study is to determine whether incorporating self-regulation training using daily weighing is efficacious within a behavioral weight loss program specifically targeting young adults.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
41
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
- Weight Control and Diabetes Research Center
-
-
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:
- body mass index between 27 and 40
- age between 21 and 35
Exclusion Criteria:
- report a history of eating disorder or a current eating disorder
- report a heart condition or other medical condition that would limit ability to participate in an exercise program without direct supervision from physician
- report major psychiatric diseases or organic brain syndromes
- currently participating in another weight loss program, are taking a weight loss medication, or have lost more than 5% of body weight curing last 6 months
- pregnant, lactating, or less than 6 months post-partum
- intend to move out of city within the time frame of the investigation or will miss multiple meetings during the study time frame
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: 1
Participants in the behavioral self-regulation intervention will receive a modified standard treatment that incorporates daily weighing and training in self-regulation methods for weight loss.
All treatment modules are adapted for a young adult age group.
|
The current study involves a behavioral weight loss intervention tailored specifically to young adults.
All participants receive calorie and activity prescriptions as well as training in behavior modification.
In addition, one group receives training in self-regulation techniques using daily weighing.
|
|
Experimental: 2
Participants in the Standard group will receive a brief version of standard behavioral weight loss treatment with treatment modules tailored to better meet the needs of young adults.
|
The current study involves a behavioral weight loss intervention tailored specifically to young adults.
All participants receive calorie and activity prescriptions as well as training in behavior modification.
In addition, one group receives training in self-regulation techniques using daily weighing.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
weight change
Time Frame: 10 weeks and 20 weeks
|
10 weeks and 20 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
eating disorder symptoms, physical activity, body image, mood symptoms, and self-efficacy about eating behavior
Time Frame: 10 weeks and 20 weeks
|
10 weeks and 20 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jessica G LaRose, Ph.D., The Miriam Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
April 1, 2007
Primary Completion (Actual)
November 1, 2007
Study Completion (Actual)
November 1, 2007
Study Registration Dates
First Submitted
June 18, 2007
First Submitted That Met QC Criteria
June 18, 2007
First Posted (Estimate)
June 20, 2007
Study Record Updates
Last Update Posted (Estimate)
April 13, 2012
Last Update Submitted That Met QC Criteria
April 12, 2012
Last Verified
January 1, 2008
More Information
Terms related to this study
Other Study ID Numbers
- CMTT# 2096-07
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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