Food, Activity and Behavior Trial

Study Overview
=================
Brief Summary
-----------------
This study will provide data on the response over 24 months to two commercial weight loss programs (center-based and telephone-based) compared to control conditions.

Detailed Description
-----------------
The first study aim is to test, in a randomized controlled trial, whether participation in the multifaceted traditional center-based commercial weight loss intervention program and/or the telephone-delivered commerical program is associated with a greater degree of weight loss at six, 12, and 18 months and whether weight loss is maintained over a 24-month period in overweight or obese women, compared to usual care or control conditions. This study utilizes a randomized study design with subjects assigned to the center-based weight loss program, telephone-delivered program, or a usual care control group. The second study aim is to describe the effect of participation in the weight loss programs (versus control conditions) on circulating lipids (fasting total plasma cholesterol and triglycerides, low-density lipoprotein [LDL] cholesterol, and high-density lipoprotein [HDL] cholesterol), carotenoids (a biomarker of vegetable and fruit intake), insulin, glucose, leptin, C-reactive protein, and vitamin D, and cardiopulmonary fitness. The center-based intervention involves in-person counseling and obtaining food items from the center, whereas the telephone-delivered program involves telephone counseling with food delivered to the home every two weeks. Secondary aims of this study involve describing the characteristics associated with greater weight loss and maintenance in each of the two intervention arms. The hypothesis to be tested is that selected participant characteristics, such as older or younger age, might be differentially associated with greater success across the two types of programs and approaches. Notably, the results of this study would contribute valuable data to the scientific knowledge base regarding the various modalities of communication for behavioral interventions (in-person versus telephone counseling). This is an important issue currently being considered and debated among clinical and community-based behavioral and nutritional scientists whose intervention efforts focus on promoting behavior change and positive effects on health-related outcomes such as weight reduction.

Official Title
-----------------
A Multi-Site Randomized Trial of a Commercial Weight Loss Program

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

Intervention / Treatment
-----------------
* Behavioral: Usual care
* Behavioral: Commercial weight loss program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and older Initial BMI >25.0 kg/m2 and <40 kg/m2 A minimum of 15 kg over ideal weight as defined by the 1983 Metropolitan Life Insurance tables Willing and able to participate in clinic visits and JC facility interactions at specified intervals and to maintain contact with the investigators for 24 months Willing to allow blood collections Capable of performing a simple test for assessing cardiopulmonary fitness Exclusion Criteria: Inability to participate in physical activity because of severe disability (e.g., severe arthritic conditions) A history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated Self-reported pregnancy or breastfeeding or planning a pregnancy within the next two years Currently actively involved in another diet intervention study or organized weight loss program Having a history or presence of a significant psychiatric disorder or any other condition that, in the investigator's judgment, would interfere with participation in the trial

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

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Commercial program at center<br> | Behavioral: Commercial weight loss program<br>* Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.<br>|
| Experimental: Commercial program over the telephone<br> | Behavioral: Commercial weight loss program<br>* Active weekly participation until weight loss goals are reached, and monthly participation to maintain the weight loss.<br>|
| Other: Usual care<br>Weight loss counseling | Behavioral: Usual care<br>* Two individualized weight loss counseling sessions with a dietetics professional, and monthly contacts to maintain communications.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss |  | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
overweight, obesity, weight loss, commercial weight loss program