A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity

Obesity Clinical Trial

— ROC  

Official title:

Self-Regulation Treatment for Pediatric Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01442142
• Other study ID #: AHC FRD 06-32
• Secondary ID: AHC FRD 06-32
• Status: Completed
• Phase: N/A
• First received: August 2, 2011
• Last updated: September 5, 2017
• Start date: May 2008
• Est. completion date: November 2010

Study information

• Verified date: September 2017
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to pilot test, evaluate and compare the effects of Cue Reactivity and Sensitivity Training (CRST) and Children's Appetite Awareness Training (CAAT) in 48 children aged 8-12 years old. The central hypothesis is that CRST and CAAT will reduce eating in the absence of hunger in overweight children immediately following treatment and 6-months post treatment.

The primary aim of this proposed study is to evaluate the efficacy and compare the effectiveness of Cue Responsivity and Sensitivity Training (CRST) or Children's Appetite Awareness Training (CAAT) in decreasing eating in the absence of hunger (EAH) in overweight children. Following this first intervention, a second intervention to determine the efficacy of a combination program (combined CAAT & CRST) will be implemented.

The secondary aim of this study is to evaluate change in the following related measures for both children and adults who participated in CRST, CAAT, and the combination program: BMI for age, food intake, perceptions of control over eating, and self-efficacy in managing high-risk food situations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) greater than the 85%-ile

• child consumes 10%+ of daily caloric need during Eating in the absence of hunger (EAH) assessment

• child between the age of 8-12 at the time of the first data collection visit

Exclusion Criteria:

• non-English speaking

• history of eating disorder

• food allergies

• unavailable on days of intervention meetings

• current participation in a weight loss or maintenance program

• presence of any medical condition affecting weight or growth

• presence of any physical, emotional, or behavioral disability that would prevent participant from taking part in the weekly study visits or the three data collection visits.

Related Conditions & MeSH terms

• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• CAAT: Appetite Awareness
Participants in this Children's Appetite Awareness Training (CAAT) group learn to get in touch with the internal cues of hunger - aka the "hunger meter" - and practice skills to get back in touch with these internal cues of true hunger and fullness. Sessions occur once a week for 8 weeks.
• CRST: Volcravo
Participants in this Cue Reactivity and Sensitivity Training (CRST) group learn about how external cues can affect when and how much we eat (aka "volcravo - the craving volcano"). Over 8 weekly sessions, they practice skills to ride out the cravings external cues can cause.
• Combined CAAT and CRST program
Participants meet weekly for 14 weeks to learn about both Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST) - i.e. appetite awareness and external cues that affect food intake.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	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	Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months		Baseline and 3 months
Secondary	Change from baseline in BMI-for-age at 3 months.		Baseline and 3 months