Promoting Healthy Weight With 'Stability Skills First'

NCT00626457 | Completed DMC

• 2 other identifiers: SU-02142008-1018R01CA112594
• Study Type: interventional
• Target: 267
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  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.

  12-month follow-up period (6-18 months)

Secondary Outcomes (2)

• Change in physical activity

  6 months

• Pedometer steps

  6 months

Study Arms (2)

Maintenance First

EXPERIMENTAL

Behavioral: Behavioral weight-loss/lifestyle interventions

Weight Loss First

ACTIVE COMPARATOR

Behavioral: Behavioral weight-loss/lifestyle interventions

Interventions

Behavioral weight-loss/lifestyle interventions BEHAVIORAL

6-month intervention (28 weekly classes)

Maintenance First; Weight Loss First

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (4)

• Kiernan M, Moore SD, Schoffman DE, Lee K, King AC, Taylor CB, Kiernan NE, Perri MG. Social support for healthy behaviors: scale psychometrics and prediction of weight loss among women in a behavioral program. Obesity (Silver Spring). 2012 Apr;20(4):756-64. doi: 10.1038/oby.2011.293. Epub 2011 Oct 13.

  PMID: 21996661 RESULT

• Brown SD, Lee K, Schoffman DE, King AC, Crawley LM, Kiernan M. Minority recruitment into clinical trials: experimental findings and practical implications. Contemp Clin Trials. 2012 Jul;33(4):620-3. doi: 10.1016/j.cct.2012.03.003. Epub 2012 Mar 16.

  PMID: 22449836 RESULT

• Kiernan M, Brown SD, Schoffman DE, Lee K, King AC, Taylor CB, Schleicher NC, Perri MG. Promoting healthy weight with "stability skills first": a randomized trial. J Consult Clin Psychol. 2013 Apr;81(2):336-46. doi: 10.1037/a0030544. Epub 2012 Oct 29.

  PMID: 23106759 RESULT

• Kiernan M, Schoffman DE, Lee K, Brown SD, Fair JM, Perri MG, Haskell WL. The Stanford Leisure-Time Activity Categorical Item (L-Cat): a single categorical item sensitive to physical activity changes in overweight/obese women. Int J Obes (Lond). 2013 Dec;37(12):1597-602. doi: 10.1038/ijo.2013.36. Epub 2013 Apr 16.

  PMID: 23588625 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michaela Kiernan

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: February 21, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

US (2)