Self-Efficacy in Weight Loss Treatment (SELF)
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|ClinicalTrials.gov Identifier: NCT00896194|
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : July 7, 2015
This randomized clinical trial of weight loss treatment will examine if adding personalized, one-on-one treatment session to standard behavioral group treatment will result in greater weight loss, less weight regain after weight loss, and better adherence to the treatment protocol.
Everyone who enrolls in the study will receive information on healthy eating, how to increase their physical activity and develop healthy exercise habits and ways to change their eating so that they will lose weight. This information will be provided at evening group sessions. There will be a total of 20 group meetings over an 18-month period that will be held:
- every week during the first month of the study,
- every other week for the second month
- once a month for months 3-12
- every 6 weeks for months 13-18
Participants in the self-efficacy group will also be asked to participate in one-on-one lifestyle counseling sessions with a study interventionist throughout the study.
Everyone will be asked to complete questionnaires, two 24-hour dietary recalls over the phone, and have blood tests done every six months (at the beginning of the study, at 6, 12, and 18 months) a total of 4 times for the study.
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity||Behavioral: Standard Behavioral Treatment Behavioral: Modified Standard Behavioral Intervention + Self-Efficacy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Self-Efficacy in Weight Loss Treatment|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
Active Comparator: 1: Standard Behavioral Treatment (SBT)
This group receives standard behavioral treatment for weight loss as described below.
Behavioral: Standard Behavioral Treatment
SBT consists of group counseling sessions where participants learn about healthy eating and physical activity. Participants are also given standard calorie goals, fat gram goals, and physical activity goals (minutes).
Experimental: 2: Modified SBT + Self-Efficacy
This group receives modified SBT with an additional self-efficacy component as described below.
Behavioral: Modified Standard Behavioral Intervention + Self-Efficacy
This group receives identical group intervention sessions. The goals (calories, fat grams, and physical activity minutes) are tailored to the individual's progress. Participants meet regularly with an interventionist for one-on-one lifestyle counseling.
- Weight [ Time Frame: 12 and 18 months post enrollment ]
- Health-related quality of life [ Time Frame: 12 and 18 months post enrollment ]
- Adherence to treatment protocol [ Time Frame: 12 and 18 months post enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896194
|United States, Pennsylvania|
|University of Pittsburgh School of Nursing|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Lora E. Burke, PhD, MPH||University of Pittsburgh|