Fresh Start Weight Loss Study - Full Text View

Sponsors and Collaborators:	Stanford University National Institutes of Health (NIH)
Information provided by:	Stanford University
ClinicalTrials.gov Identifier:	NCT00626457

Purpose

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.

Condition	Intervention
Obesity	Behavioral: Behavioral weight-loss/lifestyle intervention

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study
Official Title:	Fresh Start Weight Loss Study

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Body weight

Estimated Enrollment:	232
Study Start Date:	February 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626457

Locations

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610

Sponsors and Collaborators

Stanford University

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Michaela Kiernan

Stanford University

More Information

Additional Information:

To determine eligibility, visit the Fresh Start Weight Loss Study website http://freshstart.stanford.edu/ This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Stanford University School of Medicine ( Michaela Kiernan, Principal Investigator )
Study ID Numbers:	SU-02142008-1018
Study First Received:	February 21, 2008
Last Updated:	June 19, 2009
ClinicalTrials.gov Identifier:	NCT00626457 History of Changes
Health Authority:	USA:National Institutes of Health

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity
Weight Loss

Body Weight Changes
Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on July 02, 2009