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

University of Minnesota (UMN)

Status: Completed

Conditions: Obesity

Treatments: Behavioral: CAAT: Appetite Awareness; Behavioral: Combined CAAT and CRST program; Behavioral: CRST: Volcravo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01442142

AHC FRD 06-32 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 236 patients

Sex: All

Ages: 8 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 4 patient groups

Appetitie Awareness

Experimental group

Description:

Parents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter."

Treatment:

Behavioral: CAAT: Appetite Awareness

Cue Reactivity and Sensitivity Training

Experimental group

Description:

Parents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues.

Treatment:

Behavioral: CRST: Volcravo

Combined CAAT/CRST

Experimental group

Description:

In this 14 week intervention combining Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST), parents and kids learn about both internal hunger cues and external cues that can cause one to overeat. Skills to learn the internal hunger cues and better responses to external cues are taught.

Treatment:

Behavioral: Combined CAAT and CRST program

Control

No Intervention group

Description:

Between baseline and the post-intervention data collection point, no intervention is given. Participants are given a take home binder of intervention materials at that second data collection point; they have the option of reviewing the material prior to the final follow-up data collection point.