Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)

Study Overview
=================
Brief Summary
-----------------
Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.

Official Title
-----------------
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

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

Intervention / Treatment
-----------------
* Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training
* Behavioral: Standard Behavioral Weight Loss Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 21 and 70 years Body mass index between 27 and 40 Score 5 or above on the internal disinhibition scale of the Eating Inventory Exclusion Criteria: Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Standard behavioral weight loss treatment with cognitive and affective skills training | Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training<br>* 12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment<br>|
| Active Comparator: 2<br>Standard behavioral weight loss treatment | Behavioral: Standard Behavioral Weight Loss Treatment<br>* 12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss |  | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Internal disinhibition as measured by the Eating Inventory |  | 12 Months | 
| Physical activity as measured by the Paffenbarger |  | 12 months | 
| Dietary intake as measured by the Block Food Frequency Questionnaire |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weight loss