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

This study has been completed.
Sponsor:
Collaborator:
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT01442142
First received: August 2, 2011
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Obesity
Behavioral: CAAT: Appetite Awareness
Behavioral: CRST: Volcravo
Behavioral: Combined CAAT and CRST program
Behavioral: Control group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Self-Regulation Treatment for Pediatric Obesity

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 months [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in BMI-for-age at 3 months. [ Time Frame: Baseline and 3 months ] [ Designated as safety issue: No ]

Enrollment: 236
Study Start Date: May 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Appetitie Awareness
Parents and kids assigned to this group with learn about appetite awareness and to appropriately respond to their "hunger meter."
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.
Experimental: Cue Reactivity and Sensitivity Training
Parents and kids in this group learn about how external cues can lead to overeating and how to better respond to these cues.
Behavioral: 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.
Experimental: Combined CAAT/CRST
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.
Behavioral: 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.
No Intervention: Control
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.
Behavioral: Control group
Control group for the combined Children's Appetite Awareness Training (CAAT)/Cue Reactivity and Sensitivity Training (CRST)14-week program.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01442142

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Kerri Boutelle, PhD University of Minnesota, now Univ of CA, San Diego
Principal Investigator: Lisa J Harnack, DrPH University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Carol Peterson, PhD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT01442142     History of Changes
Other Study ID Numbers: AHC FRD 06-32
Study First Received: August 2, 2011
Last Updated: September 26, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
obesity
pediatric
childhood
overweight

Additional relevant MeSH terms:
Obesity
Pediatric Obesity
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014