Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

Obesity Clinical Trial

Official title:

Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533052
• Other study ID #: K23 DK73536 (completed)
• Secondary ID: K23DK073536
• Status: Completed
• Phase: N/A
• First received: September 20, 2007
• Last updated: March 12, 2018
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: March 2018
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Weight Loss

Intervention

Behavioral:
• Affective and Cognitive Skills Training
24-week, weekly, group behavioral weight loss treatment with affective and cognitive skills training

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	The Miriam Hospital

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body Mass Index		6 months
Secondary	Internal disinhibition as measured by the Eating Inventory	The internal disinhibition subscale of the Eating Inventory ranges from 0 to 8, with high values indicating more disinhibition.	6 months
Secondary	Treatment acceptability based on qualitative feedback		6 months
Secondary	Attendance data		6 months