Self-Efficacy in Weight Loss Treatment

Obesity Clinical Trial

— SELF  

Official title:

Self-Efficacy in Weight Loss Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00896194
• Other study ID #: P01NR010949-PRO08050004
• Status: Completed
• Phase: N/A
• First received: May 7, 2009
• Last updated: July 2, 2015
• Start date: May 2009
• Est. completion date: April 2013

Study information

• Verified date: July 2015
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh School of Nursing	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Lora Burke

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight		12 and 18 months post enrollment	No
Secondary	Health-related quality of life		12 and 18 months post enrollment	No
Secondary	Adherence to treatment protocol		12 and 18 months post enrollment	No