Self-Efficacy in Weight Loss Treatment (SELF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00896194
Recruitment Status : Completed
First Posted : May 11, 2009
Last Update Posted : July 7, 2015
Information provided by (Responsible Party):
Lora Burke, University of Pittsburgh

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Weight [ Time Frame: 12 and 18 months post enrollment ]

Secondary Outcome Measures :
  1. Health-related quality of life [ Time Frame: 12 and 18 months post enrollment ]
  2. Adherence to treatment protocol [ Time Frame: 12 and 18 months post enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • age 18 years or older
  • BMI > 27 and < 43
  • willing to be randomized to one of the two treatment conditions
  • successful completion of screening requiring 5-day recording of food intake in a paper diary
  • have at least two risk factors for coronary heart disease, e.g., overweight or obese, hypertension, dyslipidemia, positive family history (first degree relative)

NOTE: Although residing in Western Pennsylvania is not an explicit eligibility criterion, participants are asked to travel to the University of Pittsburgh frequently (weekly for the first month)

Exclusion Criteria:

  • presence of a current serious illness or unstable condition requiring physician-supervised diet and exercise (e.g., diabetes, recent acute myocardial infarction) for which physician supervision of diet and physical activity prescription is needed
  • physical limitations precluding ability to engage in physical activity at moderate intensity
  • pregnancy or intention to become pregnant in the next 18 months
  • current treatment for a psychological disorder
  • reported alcohol intake > 4 drinks/day
  • previous participation in a formal weight loss program within the past 5 years, e.g., Weight Watchers or a research program, or current use of weight loss medication
  • planned extended vacations, absences, or relocation within the next 18 months

Information from the National Library of Medicine

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 identifier (NCT number): NCT00896194

United States, Pennsylvania
University of Pittsburgh School of Nursing
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Lora Burke
Principal Investigator: Lora E. Burke, PhD, MPH University of Pittsburgh

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lora Burke, Professor of Nursing and Epidemiology, University of Pittsburgh Identifier: NCT00896194     History of Changes
Other Study ID Numbers: P01NR010949-PRO08050004
P01NR010949 ( U.S. NIH Grant/Contract )
First Posted: May 11, 2009    Key Record Dates
Last Update Posted: July 7, 2015
Last Verified: July 2015

Keywords provided by Lora Burke, University of Pittsburgh:
Treatment Adherence

Additional relevant MeSH terms:
Weight Loss
Body Weight
Signs and Symptoms
Body Weight Changes