A Test of Nutritional Interventions to Enhance Weight Loss Maintenance
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|ClinicalTrials.gov Identifier: NCT01065974|
Recruitment Status : Completed
First Posted : February 10, 2010
Last Update Posted : October 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Overweight Obesity Weight Loss Maintenance||Behavioral: Behavior Therapy Dietary Supplement: Meal Replacements Behavioral: Nutritrol||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||262 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Test of Nutritional Interventions to Enhance Weight Loss Maintenance|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||April 30, 2016|
|Actual Study Completion Date :||April 30, 2016|
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:
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.
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:
To make widespread nutritional changes to participants personal food environments.
- Change in Body weight over time. [ Time Frame: Baseline, 6 months, 12 months, 18 months, 24 months, 36 months ]Change in body weight measured on electronic scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065974
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19102|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Michael R Lowe, Ph.D.||Drexel University|