A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
NCT ID: NCT01065974
Last Updated: 2017-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
262 participants
INTERVENTIONAL
2009-10-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Behavior Therapy
Weight loss using CBT and continued CBT during weight loss maintenance.
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.
Meal Replacements
Weight loss using CBT and meal replacements.
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
Nutritrol
To make widespread nutritional changes to participants personal food environments.
Interventions
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Behavior Therapy
Weight loss using CBT and continued CBT during weight loss maintenance.
Meal Replacements
Weight loss using CBT and meal replacements.
Nutritrol
To make widespread nutritional changes to participants personal food environments.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
Drexel University
OTHER
Responsible Party
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Michael Lowe
Professor
Principal Investigators
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Michael R Lowe, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Drexel University
Locations
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Drexel University
Philadelphia, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
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.
Other Identifiers
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5R01DK80909-2
Identifier Type: -
Identifier Source: org_study_id