Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments standard behavioral weight loss treatment with affective and cognitive skills training, standard behavioral weight loss treatment
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date August 2009
End date January 2011
Trial size 120 participants
Trial identifier NCT00558194, 1 K23 DK073536-01, K23 DK73536-2

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Standard behavioral weight loss treatment with cognitive and affective skills training
standard behavioral weight loss treatment with affective and cognitive skills training
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
(Active Comparator)
Standard behavioral weight loss treatment
standard behavioral weight loss treatment
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment

Primary Outcomes

Measure
Weight Loss
time frame: 12 Months

Secondary Outcomes

Measure
Internal disinhibition as measured by the Eating Inventory
time frame: 12 Months
Physical activity as measured by the Paffenbarger
time frame: 12 months
Dietary intake as measured by the Block Food Frequency Questionnaire
time frame: 12 months

Eligibility Criteria

Male or female participants from 21 years up to 70 years old.

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.

Additional Information

Official title Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment
Principal investigator Heather M. Niemeier, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2011.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).