A Test of Nutritional Interventions to Enhance Weight Loss Maintenance

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
University of Pennsylvania
Information provided by (Responsible Party):
Michael Lowe, Drexel University
ClinicalTrials.gov Identifier:
NCT01065974
First received: February 8, 2010
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Overweight
Obesity
Weight Loss Maintenance
Behavioral: Behavior Therapy
Dietary Supplement: Meal Replacements
Behavioral: Nutritrol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Test of Nutritional Interventions to Enhance Weight Loss Maintenance

Resource links provided by NLM:


Further study details as provided by Drexel University:

Primary Outcome Measures:
  • Body weight [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
  • Nutritional intake [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
  • Psychosocial measures [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 295
Study Start Date: October 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Behavior Therapy

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
Behavioral: Behavior Therapy
Weight loss using CBT and continued CBT during weight loss maintenance.
Experimental: Behavior Therapy + Meal Replacements
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.
Dietary Supplement: Meal Replacements
Weight loss using CBT and meal replacements.
Experimental: Nutritrol

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
Behavioral: Nutritrol
To make widespread nutritional changes to participants personal food environments.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01065974

Locations
United States, Pennsylvania
Drexel University
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Drexel University
University of Pennsylvania
Investigators
Principal Investigator: Michael R Lowe, Ph.D. Drexel University
  More Information

No publications provided

Responsible Party: Michael Lowe, Professor, Drexel University
ClinicalTrials.gov Identifier: NCT01065974     History of Changes
Other Study ID Numbers: 5R01DK80909-2
Study First Received: February 8, 2010
Last Updated: March 26, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Drexel University:
Nutritional Intake
Psychosocial Outcome

Additional relevant MeSH terms:
Obesity
Weight Loss
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on August 26, 2014