- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00575731
Behavioral Strategies for Weight Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Stanford, California, United States, 94305
- Stanford University School of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:(a)Web screen: Men or women of any ethnic background; age 18 years or older; body mass index (BMI) 25-39; planning to remain in the area for the next six months; not pregnant or not planning to become pregnant within the next six months; has no history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; not currently under medical care for any of the following conditions: cardiovascular problems (stroke, heart attack, chest pain, bypass surgery, etc.); cancer (except skin cancer); diabetes; respiratory problems (chronic asthma, bronchitis, etc.); or psychiatric condition; not currently taking or stable on medications for vascular problems (such as high blood pressure); able to participate in physical activity; does not meet Diagnostic and Statistical Manual criteria for binge eating; does not have a health condition that requires a special diet; not participating in a weight-loss program; not participating in support groups that focus on weight and eating habits; not taking weight-loss medication; not participating in any other research trial; and willing to be randomly assigned to either intervention.
(b)Pre-randomization: Completes all of the following in a timely and thorough manner: baseline clinic visit, baseline questionnaires on the study website, and obtains medical approval for participation (if applicable). Exclusion Criteria:(a)Web screen: Men or women of any ethnic background; age 18 years or older; body mass index (BMI) 25-39; planning to remain in the area for the next six months; not pregnant or not planning to become pregnant within the next six months; has no history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; not currently under medical care for any of the following conditions: cardiovascular problems (stroke, heart attack, chest pain, bypass surgery, etc.); cancer (except skin cancer); diabetes; respiratory problems (chronic asthma, bronchitis, etc.); or psychiatric condition; not currently taking or stable on medications for vascular problems (such as high blood pressure); able to participate in physical activity; does not meet Diagnostic and Statistical Manual criteria for binge eating; does not have a health condition that requires a special diet; not participating in a weight-loss program; not participating in support groups that focus on weight and eating habits; not taking weight-loss medication; not participating in any other research trial; and willing to be randomly assigned to either intervention.
(b)Pre-randomization: Completes all of the following in a timely and thorough manner: baseline clinic visit, baseline questionnaires on the study website, and obtains medical approval for participation (if applicable).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fine-Tuning
2-month intervention (8 lifestyle counseling classes)
|
|
|
Active Comparator: Record-Keeping
2-month intervention (8 lifestyle counseling classes)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Weighing attitudes and behavior
Time Frame: 6 months
|
6 months
|
|
Weight fluctuations
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Psychological outcomes
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michaela Kiernan, Stanford University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SU-11082007-857
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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