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

Self-Regulation Treatment for Pediatric Obesity

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01442142
Acronym
ROC
Enrollment
236
Registered
2011-09-28
Start date
2008-05-31
Completion date
2010-11-30
Last updated
2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, pediatric, childhood, overweight

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.

Interventions

BEHAVIORALCAAT: 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.

BEHAVIORALCRST: 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.

BEHAVIORALCombined 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.

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Change from baseline in the amount of calories consumed during the Eating in the Absence of Hunger assessment at 3 monthsBaseline and 3 months

Secondary

MeasureTime frame
Change from baseline in BMI-for-age at 3 months.Baseline and 3 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026