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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 21, 2008 | ||||
| Last Updated Date | June 19, 2009 | ||||
| Start Date ICMJE | February 2008 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Body weight | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00626457 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Fresh Start Weight Loss Study | ||||
| Official Title ICMJE | Fresh Start Weight Loss Study | ||||
| Brief Summary | Losing weight has many health benefits for women such as reducing the risk of heart attacks, high blood pressure, diabetes, and cancer. However, women often struggle with maintaining the weight they have lost. This may be because they need to learn skills for maintaining weight, not just losing weight. When is the optimal time is to learn these maintenance skills? It may be better to lose weight first and then learn maintenance skills since people may feel good about the weight they have lost and be motivated to maintain. Alternatively, it may be better to learn maintenance skills first and then lose weight since they may experience how easy it is to use these maintenance skills and become confident they can maintain a weight loss in the future. Therefore, this study will examine whether learning these maintenance skills--before or after losing weight--helps women succeed at maintaining weight loss. |
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| Detailed Description | |||||
| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study | ||||
| Condition ICMJE | Obesity | ||||
| Intervention ICMJE | Behavioral: Behavioral weight-loss/lifestyle intervention | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 232 | ||||
| Estimated Completion Date | May 2011 | ||||
| Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:These criteria include: women of any ethnic background; age 21 years or older; BMI 27-40; non diabetic; not pregnant or not planning to become pregnant within the next year and a half; planning to remain in the area for the next year and a half; not following a special diet; not participating in any other research trial, not participating in another weight-loss program or weight or eating habits support group; able to participate in physical activity; free of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; stable blood pressure, cholesterol, thyroid and/or hormone medications for at least 3 months; not taking weight-loss medications, and successful and timely completion of the eligibility process. Exclusion Criteria:These criteria include: all men; women younger than 21 years of age; BMI outside of range 27-40; diabetic; pregnant or planning to become pregnant within the next year and a half; not planning to remain in the area for the next year and a half; following a special diet; participating in another research trial; participating in another weight-loss program or weight or eating habits support group; not able to participate in physical activity; has a history of heart disease, including stroke, heart attack, coronary artery bypass surgery, or balloon angioplasty; taking blood pressure, cholesterol, thyroid, and/or hormone medications for less than 3 months; taking weight-loss medications, or unsuccessful and/or untimely completion of the eligibility process. |
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| Gender | Female | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00626457 | ||||
| Responsible Party | Michaela Kiernan, Principal Investigator, Stanford University School of Medicine | ||||
| Study ID Numbers ICMJE | SU-02142008-1018 | ||||
| Study Sponsor ICMJE | Stanford University | ||||
| Collaborators ICMJE | National Institutes of Health (NIH) | ||||
| Investigators ICMJE |
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| Information Provided By | Stanford University | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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