Self-Efficacy in Weight Loss Treatment

Study Overview
=================
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.

Official Title
-----------------
Self-Efficacy in Weight Loss Treatment

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Behavioral: Standard Behavioral Treatment
* Behavioral: Modified Standard Behavioral Intervention + Self-Efficacy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1: Standard Behavioral Treatment (SBT)<br>This group receives standard behavioral treatment for weight loss as described below. | Behavioral: Standard Behavioral Treatment<br>* 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).<br>|
| Experimental: 2: Modified SBT + Self-Efficacy<br>This group receives modified SBT with an additional self-efficacy component as described below. | Behavioral: Modified Standard Behavioral Intervention + Self-Efficacy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | 12 and 18 months post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | 12 and 18 months post enrollment | 
| Adherence to treatment protocol |  | 12 and 18 months post enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Overweight, Obesity, Self-Efficacy, Treatment Adherence