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

Treating Overweight Youth: A Family Based Approach in Primary Care

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01029834

Enrollment

105

Registered

2009-12-10

Start date

2008-04-30

Completion date

2013-06-30

Last updated

2023-04-28

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

Conditions

Overweight

Keywords

BMI >85%for age and gender

Brief summary

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.

Interventions

BEHAVIORALfamily based lifestyle and behavioral counseling

16 group meetings

BEHAVIORALcounseling focused on the child

16 meetings

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Caregiver)

Eligibility

Sex/Gender

ALL

Age

2 Years to 6 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Percent BMI overweight for child and parent	baseline-6,12,18, 24 months

Secondary

Measure	Time frame
Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity	baseline, 6,12,18,24

Countries

United States

Outcome results

None listed

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