Promoting Healthy Weight With 'Stability Skills First' (Fresh Start Weight Loss Study)
21 Years
N/A
Female
Obesity
Trial Information
Promoting Healthy Weight With 'Stability Skills First' (Fresh Start Weight Loss Study)
This randomized trial will test whether learning a novel set of 'stability skills' before
losing weight improves long-term weight management (i.e., during a subsequent follow-up
period once classes and staff contact have ended). Overweight/obese participants will be
randomly assigned to one of two conditions (Maintenance First or Weight Loss First). In the
Maintenance First condition, participants will learn stability skills during a novel 8-week
maintenance program before participating in a standard 20-week behavioral weight-loss
program. In the Weight Loss First condition (usual care/active comparator condition),
participants will participate in a standard 20-week behavioral weight-loss program followed
by a standard 8-week problem-solving skills maintenance program. Participants in both
conditions will participate in identical standard 20-week behavioral weight-loss programs
and be offered the same number of 90-minute weekly classes over the 6-month intervention
period, (thus matching for time and attention from study-led health educators). Participants
will be assessed at baseline and 6 months during the 6-month intervention period and at 12
and 18 months during the subsequent 12-month follow-up period (i.e., after classes and staff
contact have ended). There will be no intervention staff contact during the 12-month
follow-up, only 6, 12 and 18-month assessments. The primary aim will test whether
participants in the Maintenance First condition gain less weight during the 12-month
follow-up period (i.e., 6-18 months) than those in the Weight Loss First (active comparator)
condition. Secondary questions of interest include examining psychometrics of lifestyle
behavior questions (e.g., physical activity).
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Change in body weight
Outcome Description:
Body weight will be measured at baseline, 6, 12, and 18 months on a California state-certified standard beam balance scale at the research center with participants in light clothing and without shoes.
Outcome Time Frame:
12-month follow-up period (6-18 months)
Safety Issue:
No
Principal Investigator
Michaela Kiernan
Investigator Role:
Principal Investigator
Investigator Affiliation:
Stanford University
Authority:
United States: Federal Government
Study ID:
SU-02142008-1018
NCT ID:
NCT00626457
Start Date:
February 2008
Completion Date:
May 2011
Related Keywords:
- Obesity
- Obesity
Name | Location |
|---|---|
| Stanford University School of Medicine | Stanford, California 94305-5317 |
| University of Florida | Gainesville, Florida 32610-0277 |
