This trial is active, not recruiting.

Conditions overweight, obesity
Treatment standard behavioral weight loss treatment plus affective and cognitive skills training
Sponsor National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2007
End date May 2008
Trial size 21 participants
Trial identifier NCT00533052, 1 K23 DK073536-01, K23 DK73536 (completed)


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 is an uncontrolled pilot study in 20 participants to initially assess acceptability and efficacy of the innovative treatment. 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

Intervention model single group assignment
Masking open label
Primary purpose treatment
Standard Behavioral Weight Loss Treatment Plus Affective and Cognitive Skills Training
standard behavioral weight loss treatment plus affective and cognitive skills training
24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training

Primary Outcomes

Body Mass Index
time frame: 6 months

Secondary Outcomes

Internal disinhibition as measured by the Eating Inventory
time frame: 6 months
Treatment acceptability based on qualitative feedback
time frame: 6 months
Attendance data
time frame: 6 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 January 2011.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).