Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)

Not Applicable

Withdrawn

• Conditions: Obesity; Overweight
• Interventions: Behavioral: Standard Behavioral Weight Loss Treatment; Behavioral: Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training

• Registration Number: NCT00558194
• Lead Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-13
• Study First Submitted QC: 2007-11-13
• Study First Posted: 2007-11-14
• Study Start: 2009-08
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-12
• Last Update Posted: 2018-03-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age between 21 and 70 years
• Body mass index between 27 and 40
• Score 5 or above on the internal disinhibition scale of the Eating Inventory

Exclusion Criteria

• Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
• Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
• Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Standard Behavioral Weight Loss Treatment	Standard behavioral weight loss treatment
1	Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training	Standard behavioral weight loss treatment with cognitive and affective skills training

Primary Outcome Measures

Name	Time	Method
Weight Loss	12 Months

Secondary Outcome Measures

Name	Time	Method
Internal disinhibition as measured by the Eating Inventory	12 Months
Physical activity as measured by the Paffenbarger	12 months
Dietary intake as measured by the Block Food Frequency Questionnaire	12 months

Trial Locations

Locations (1)

The Weight Control and Diabetes Research Center, The Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States