This trial is active, not recruiting.

Conditions overweight, obesity, weight loss maintenance
Treatments behavior therapy, meal replacements, nutritrol
Sponsor Drexel University
Collaborator University of Pennsylvania
Start date October 2009
End date December 2016
Trial size 295 participants
Trial identifier NCT01065974, 5R01DK80909-2


The purpose of this study is to compare standard Behavior Therapy (BT), BT plus Meal Replacements (MR) and a condition focusing on the nutritional control of body weight (Nutritrol) 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
(Active Comparator)
Behavioral treatment strategies will be utilized to facilitate adherence to the treatment goals in all three treatments. Participants in the BT condition will receive only the BT intervention. Strategies that will be emphasized are listed below: Self monitoring Stimulus control Changing eating behaviors Goal setting Problem solving Social support Cognitive restructuring Relapse prevention
behavior therapy
Weight loss using CBT and continued CBT during weight loss maintenance.
The BT +MR condition will implement behavioral treatment strategies in a way that is nearly identical to that of the BT condition. However, participants in this condition also will use MRs during weight loss and weight loss maintenance.
meal replacements
Weight loss using CBT and meal replacements.
Participants in this condition will be informed about the evidence indicating that the availability, structure and composition of foods they encounter or seek out in their daily lives will play a major role in determining their ability to maintain the weight they lose. We will present the treatment as an opportunity to make numerous changes to their "personal food environment" involving the variety, energy density, nutritional composition, and portion size of the foods they encounter in every day life. The Nutritrol condition is comprised of several components: Food structure Energy density Reduce variety of foods high in energy density and increase variety of foods low in energy density Protein intake Controlling the personal food environment Individualized weight loss maintenance prescriptions
To make widespread nutritional changes to participants personal food environments.

Primary Outcomes

Body weight
time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Nutritional intake
time frame: Baseline, 6 months, 12 months, 18 months, 24 months
Psychosocial measures
time frame: Baseline, 6 months, 12 months, 18 months, 24 months

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Have a BMI between 27 and 45 kg/m2 - Have the ability to engage in physical activity (i.e., can walk at least 2 blocks without stopping for rest) - Successfully complete all steps in the enrollment process, including completion of a 7-day food diary and attendance at all pre-randomization clinic visits Exclusion Criteria: - Have a medical condition (e.g., cancer) or psychiatric condition (e.g., psychotic disorder, substance dependence, bulimia nervosa) that may limit their ability to comply with the behavioral recommendations of the program or pose a risk to the participant during weight loss - Are pregnant or plan to become pregnant in next 2 years - Report recently beginning a course of or changing the dosage of prescription medications that can cause significant weight loss or weight gain - Are participating in or plan to participate in another weight loss program in the next 2 years

Additional Information

Official title A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
Principal investigator Michael R Lowe, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Drexel University.