Treating Pre-School Children at Risk for Overweight in the Primary Care Setting

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2013-06-30

Brief Summary

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The goal of this study is to test, in the primary care setting, the efficacy of an innovative intervention program for children aged 2-5 years with a BMI over the 85th percentile and one overweight parent (BMI \>27 kg/m2.

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Detailed Description

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Conditions

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Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Caregivers

Study Groups

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Intervention- Lifestyle family based

Behavioral family based

Group Type EXPERIMENTAL

family based lifestyle and behavioral counseling

Intervention Type BEHAVIORAL

16 group meetings

Information control

Child intervention only

Group Type ACTIVE_COMPARATOR

counseling focused on the child

Intervention Type BEHAVIORAL

16 meetings

Interventions

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family based lifestyle and behavioral counseling

16 group meetings

Intervention Type BEHAVIORAL

counseling focused on the child

16 meetings

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 2-5 year old with a BMI greater than the 85th% for age and sex
* one overweight parent (BMI\>27kg/m2)
* child with normal developmental milestones
* history of adherence to 90% of scheduled primary care visits
* parent must be at 5th grade reading and speaking of English language or the spanish language
* no plans on moving out of the area for the 2 years subsequent to enrollment

Exclusion Criteria

* child with a height 2 SD below the mean for age and sex and/or pathological growth velocity
* SGA
* any chronic disorders influencing energy intake and/or growth
* any orthopedic disorder preventing the child or the parent from ambulation normally and performing the activity prescribed by the program
* any medication known to have the potential of affecting weight changes
* parent or child with psychiatric and/or eating disorder
* participating mother who is pregnant or planning a pregnancy
* parent being acquainted with the parent of a previously randomized study participant

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes