Self-Efficacy in Weight Loss Treatment

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2013-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1: Standard Behavioral Treatment (SBT)

This group receives standard behavioral treatment for weight loss as described below.

Group Type ACTIVE_COMPARATOR

Standard Behavioral Treatment

Intervention Type BEHAVIORAL

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).

2: Modified SBT + Self-Efficacy

This group receives modified SBT with an additional self-efficacy component as described below.

Group Type EXPERIMENTAL

Modified Standard Behavioral Intervention + Self-Efficacy

Intervention Type BEHAVIORAL

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.

Interventions

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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).

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes