Clinical trial NCT01442142: A Study to Determine the Effectiveness of a Self-regulation Program to Treat Pediatric Obesity
Official title: Self-Regulation Treatment for Pediatric Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obesity
pediatric
childhood
overweight
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2011-09-28
Enrollment: 236
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Change from baseline in BMI-for-age at 3 months.
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota, now Univ of CA, San Diego
name: Kerri Boutelle, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Lisa J Harnack, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Minnesota
name: Carol Peterson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boutelle KN, Zucker N, Peterson CB, Rydell S, Carlson J, Harnack LJ. An intervention based on Schachter's externality theory for overweight children: the regulation of cues pilot. J Pediatr Psychol. 2014 May;39(4):405-17. doi: 10.1093/jpepsy/jst142. Epub 2014 Jan 23.