NCT01029834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

5.2 years

First QC Date

December 9, 2009

Last Update Submit

April 26, 2023

Conditions

Overweight

Keywords

BMI >85%for age and gender

Outcome Measures

Primary Outcomes (1)

  • Percent BMI overweight for child and parent

    baseline-6,12,18, 24 months

Secondary Outcomes (1)

  • Reduction in number of sugared drinks, high energy food and sedentary activities. Increase in fruit, vegetable and physical activity

    baseline, 6,12,18,24

Study Arms (2)

Intervention- Lifestyle family based

EXPERIMENTAL

Behavioral family based

Behavioral: family based lifestyle and behavioral counseling

Information control

ACTIVE COMPARATOR

Child intervention only

Behavioral: counseling focused on the child

Interventions

family based lifestyle and behavioral counselingBEHAVIORAL

16 group meetings

Intervention- Lifestyle family based
counseling focused on the childBEHAVIORAL

16 meetings

Information control

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

WNY urban practices

Buffalo, New York, United States

Location

WNY suburban practices

Williamsville, New York, United States

Location

Related Publications (2)

  • Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Treatment outcomes of overweight children and parents in the medical home. Pediatrics. 2014 Aug;134(2):290-7. doi: 10.1542/peds.2013-4084.

    PMID: 25049340DERIVED

  • Quattrin T, Roemmich JN, Paluch R, Yu J, Epstein LH, Ecker MA. Efficacy of family-based weight control program for preschool children in primary care. Pediatrics. 2012 Oct;130(4):660-6. doi: 10.1542/peds.2012-0701. Epub 2012 Sep 17.

    PMID: 22987879DERIVED

MeSH Terms

Conditions

OverweightCoitus

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSexual BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Teresa Quattrin, MD

    University at Buffalo/Women and Children's Hospital of Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Diabetes/Endocrinology

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

April 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations

US(2)