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

Obesity Clinical Trial

Official title:

Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00558194
• Other study ID #: K23 DK73536-2
• Secondary ID: K23DK073536
• Status: Withdrawn
• Phase: N/A
• First received: November 13, 2007
• Last updated: March 12, 2018
• Start date: August 2009
• Est. completion date: January 2011

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• 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:
• Standard Behavioral Weight Loss Treatment with Affective and Cognitive Skills Training
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment
• Standard Behavioral Weight Loss Treatment
12-month (6-month weekly, 3-month biweekly, 3-month monthly) group treatment

Locations

Country	Name	City	State
United States	The Weight Control and Diabetes Research Center, The Miriam Hospital	Providence	Rhode Island

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight Loss		12 Months
Secondary	Internal disinhibition as measured by the Eating Inventory		12 Months
Secondary	Physical activity as measured by the Paffenbarger		12 months
Secondary	Dietary intake as measured by the Block Food Frequency Questionnaire		12 months