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Sponsored by: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
ClinicalTrials.gov Identifier: | NCT00558194 |
Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.
Condition | Intervention |
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Overweight Obesity |
Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training Behavioral: Standard Behavioral Weight Loss Treatment |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment |
Estimated Enrollment: | 120 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Standard behavioral weight loss treatment with cognitive and affective skills training
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Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
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2: Active Comparator
Standard behavioral weight loss treatment
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Behavioral: Standard Behavioral Weight Loss Treatment
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
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Ages Eligible for Study: | 21 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Heather M. Niemeier, Ph.D. | 401-793-8980 | hniemeier@lifespan.org |
United States, Rhode Island | |
The Weight Control and Diabetes Research Center, The Miriam Hospital | |
Providence, Rhode Island, United States, 02903 |
Principal Investigator: | Heather M. Niemeier, Ph.D. | The Miriam Hospital/The Warren Alpert Medical School of Brown U niversity |
Responsible Party: | The Miriam Hospital ( Heather M. Niemeier, Ph.D. ) |
Study ID Numbers: | DK73536-2, 1 K23 DK073536-01 |
Study First Received: | November 13, 2007 |
Last Updated: | November 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00558194 |
Health Authority: | United States: Federal Government |
Weight loss |
Body Weight Signs and Symptoms Obesity Weight Loss |
Body Weight Changes Nutrition Disorders Overnutrition Overweight |