Back to resultsA Test of Nutritional Interventions to Enhance Weight Loss Maintenance
Primary Purpose
Overweight, Obesity, Weight Loss Maintenance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavior Therapy
Meal Replacements
Nutritrol
Sponsored by
About this trial
This is an interventional treatment trial for Overweight focused on measuring Nutritional Intake, Psychosocial Outcome
Eligibility Criteria
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
Sites / Locations
- Drexel University
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Behavior Therapy
Behavior Therapy + Meal Replacements
Nutritrol
Arm Description
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
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.
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
Outcomes
Primary Outcome Measures
Change in Body weight over time.
Change in body weight measured on electronic scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT01065974
First Posted
February 8, 2010
Last Updated
October 5, 2017
Sponsor
Drexel University
Collaborators
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT01065974
Brief Title
A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
Official Title
A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
April 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Drexel University
Collaborators
University of Pennsylvania
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity, Weight Loss Maintenance
Keywords
Nutritional Intake, Psychosocial Outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
262 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavior Therapy
Arm Type
Active Comparator
Arm Description
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
Arm Title
Behavior Therapy + Meal Replacements
Arm Type
Experimental
Arm Description
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.
Arm Title
Nutritrol
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Behavior Therapy
Intervention Description
Weight loss using CBT and continued CBT during weight loss maintenance.
Intervention Type
Dietary Supplement
Intervention Name(s)
Meal Replacements
Intervention Description
Weight loss using CBT and meal replacements.
Intervention Type
Behavioral
Intervention Name(s)
Nutritrol
Intervention Description
To make widespread nutritional changes to participants personal food environments.
Primary Outcome Measure Information:
Title
Change in Body weight over time.
Description
Change in body weight measured on electronic scale.
Time Frame
Baseline, 6 months, 12 months, 18 months, 24 months, 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael R Lowe, Ph.D.
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
29381791
Citation
Lowe MR, Butryn ML, Zhang F. Evaluation of meal replacements and a home food environment intervention for long-term weight loss: a randomized controlled trial. Am J Clin Nutr. 2018 Jan 1;107(1):12-19. doi: 10.1093/ajcn/nqx005.
Results Reference
derived
PubMed Identifier
28845608
Citation
Feig EH, Lowe MR. Variability in Weight Change Early in Behavioral Weight Loss Treatment: Theoretical and Clinical Implications. Obesity (Silver Spring). 2017 Sep;25(9):1509-1515. doi: 10.1002/oby.21925.
Results Reference
derived
Learn more about this trial
A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
We'll reach out to this number within 24 hrs