Promoting Healthy Weight With 'Stability Skills First'

NCT ID: NCT00626457

Last Updated: 2015-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2011-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Maintenance First

Group Type EXPERIMENTAL

Behavioral weight-loss/lifestyle interventions

Intervention Type BEHAVIORAL

6-month intervention (28 weekly classes)

Weight Loss First

Group Type ACTIVE_COMPARATOR

Behavioral weight-loss/lifestyle interventions

Intervention Type BEHAVIORAL

6-month intervention (28 weekly classes)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral weight-loss/lifestyle interventions

6-month intervention (28 weekly classes)

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michaela Kiernan

Senior Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michaela Kiernan

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Stanford University School of Medicine

Stanford, California, United States

Site Status

University of Florida

Gainesville, Florida, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 21996661 (View on PubMed)

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.

Reference Type RESULT
PMID: 22449836 (View on PubMed)

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.

Reference Type RESULT
PMID: 23106759 (View on PubMed)

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.

Reference Type RESULT
PMID: 23588625 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01CA112594

Identifier Type: NIH

Identifier Source: secondary_id

View Link

SU-02142008-1018

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Weight Gain Prevention
NCT00606840 COMPLETED NA
Motivations for Weight Loss
NCT00011115 COMPLETED NA
Physical Activity Choices Everyday
NCT03824769 COMPLETED NA
Prevention of Weight Gain
NCT00011102 COMPLETED NA