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Self-Efficacy in Weight Loss Treatment (SELF)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00896194
First received: May 7, 2009
Last updated: July 12, 2011
Last verified: July 2011
History of Changes
  Purpose

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 Intervention
Overweight
Obesity
 Behavioral: Standard Behavioral Treatment
Behavioral: Modified Standard Behavioral Intervention + Self-Efficacy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-Efficacy in Weight Loss Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Weight [ Time Frame: 12 and 18 months post enrollment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health-related quality of life [ Time Frame: 12 and 18 months post enrollment ] [ Designated as safety issue: No ]
  • Adherence to treatment protocol [ Time Frame: 12 and 18 months post enrollment ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: May 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896194

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

No publications provided

Responsible Party: Lora E. Burke, PhD, MPH, FAAN, FAHA, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00896194     History of Changes
Other Study ID Numbers: P01NR010949-PRO08050004
Study First Received: May 7, 2009
Last Updated: July 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Overweight
Obesity
Self-Efficacy
Treatment Adherence

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 23, 2013