Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

NCT ID: NCT00533052

Last Updated: 2018-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2008-07-31

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 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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Affective and Cognitive Skills Training

Standard Behavioral Weight Loss Treatment Plus Affective and Cognitive Skills Training

Group Type: EXPERIMENTAL

Affective and Cognitive Skills Training

Intervention Type: BEHAVIORAL

24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training

Interventions

Affective and Cognitive Skills Training

24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Miriam Hospital

OTHER

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather M. Niemeier, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Miriam Hospital/The Warren Alpert Medical School of Brown University

Locations

The Miriam Hospital

Providence, Rhode Island, United States

Countries

United States

References

Niemeier HM, Leahey T, Palm Reed K, Brown RA, Wing RR. An acceptance-based behavioral intervention for weight loss: a pilot study. Behav Ther. 2012 Jun;43(2):427-35. doi: 10.1016/j.beth.2011.10.005. Epub 2011 Dec 1.

Reference Type: RESULT

PMID: 22440077 (View on PubMed)

Other Identifiers

K23DK073536

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23 DK73536 (completed)

Identifier Type: -

Identifier Source: org_study_id