Overweight, Obesity, Weight Loss Maintenance
Conditions
Keywords
Nutritional Intake, Psychosocial Outcome
Brief summary
The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional changes to the home food environment (HFE) on weight loss, weight loss maintenance, nutritional composition of the diet and psychosocial outcomes. A second aim is to determine the degree to which the specific targets of the experimental interventions do in fact change in the anticipated direction during the intervention and to evaluate whether such changes might account for improvements in weight loss maintenance. This study is important because it could provide the first evidence that the current standard of care for obesity lifestyle treatment could be improved by the addition of MRs or a program of comprehensive nutritional change.
Interventions
BEHAVIORALBehavior Therapy
Weight loss using CBT and continued CBT during weight loss maintenance.
DIETARY_SUPPLEMENTMeal Replacements
Weight loss using CBT and meal replacements.
BEHAVIORALNutritrol
To make widespread nutritional changes to participants personal food environments.
Sponsors
University of Pennsylvania
Drexel University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants between the ages of 18 and 65 * body mass index (BMI; kg/m2) between 27-45 * able to travel regularly to the study location * interested in participating in a weight loss program.
Exclusion criteria
* currently enrolled in another organized weight loss program * lactose intolerance * taking medications that affect appetite (unless dosage had been stable for at least the previous six months) * history of gastric bypass or other surgical weight loss procedures * medical conditions (e.g., cancer, substance abuse, psychotic disorders) that could limit their ability to comply with the behavioral recommendations or pose a risk to the participant during weight loss * pregnancy or planning to become pregnant during the next two years - * breastfeeding * consuming an amount of alcohol that could interfere with study completion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body weight over time. | Baseline, 6 months, 12 months, 18 months, 24 months, 36 months | Change in body weight measured on electronic scale. |
Countries
United States
Outcome results
None listed