NCT01080885

Brief Summary

The goals of this study are to evaluate the feasibility, acceptability, and potential efficacy of an innovative obesity prevention intervention integrating pediatrician counseling and a home-based program to prevent unhealthy weight gain among 2-4 year old children at risk for obesity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2010

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 23, 2012

Status Verified

April 1, 2012

Enrollment Period

1 year

First QC Date

March 3, 2010

Last Update Submit

April 20, 2012

Conditions

Obesity

Keywords

PreventionPrevention of unhealthy weight gain

Outcome Measures

Primary Outcomes (4)

  • Parent and pediatrician participation and satisfaction

    Parents of at risk preschool children and pediatricians will show high participation rates in and report high levels of satisfaction with the interventions.

    6 months

  • Healthy Eating

    Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of sweetened beverage and higher levels of lower fat/calorie snack and meal consumption compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. The Nutrition Data System for Research will be used to measure this change.

    6 months

  • Levels of TV watching

    Healthy Eating/Physical Activity Home-based Intervention participants will show lower levels of TV watching compared to Safety/Injury Prevention Home-based Contact Control Intervention participants;

    6 months

  • Physical activity levels

    Healthy Eating/Physical Activity Home-based Intervention participants will show higher levels of physical activity compared to Safety/Injury Prevention Home-based Contact Control Intervention participants. Physical activity level will be measured by accelerometry.

    6 months

Secondary Outcomes (2)

  • Hypothesized mediators of BMI change

    6 months

  • Body mass index (BMI) percentile

    6 months

Study Arms (2)

Busy Bodies/Better Bites

EXPERIMENTAL

Healthy Eating/Physical Activity Intervention

Behavioral: Busy Bodies/Better Bites

Healthy Spots/Safe Tots

ACTIVE COMPARATOR

Injury Prevention and Safety Intervention

Behavioral: Healthy Spots/Safe Tots

Interventions

Busy Bodies/Better BitesBEHAVIORAL

This intervention will include brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the healthy eating and physical activity home environmental strategies.

Busy Bodies/Better Bites
Healthy Spots/Safe TotsBEHAVIORAL

This intervention will include the same brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.

Healthy Spots/Safe Tots

Eligibility Criteria

Age2 Years - 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • BMI between the 85th and 95th percentile for age and gender or
  • BMI between the 50th and 85th percentile and at least one overweight parent (BMI ≥ 25 kg/m2)
  • Receives care at a HealthPartners Clinic in the Twin Cities Metropolitan Area

You may not qualify if:

  • Children with the following chronic conditions: kidney disease, Type 1 diabetes, lupus, a thyroid condition, cancer or a chromosomal abnormality such as Down's syndrome or Turner's syndrome.
  • Children who within the last six months or who those who are currently taking the following medications and took them or will be taking them for more than a month: Prednisone, Prednisolone and Decadron.
  • Families who have limited English skills.
  • Families who plan to move out of the metropolitan area within the next six months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthPartners Research Foundation

Bloomington, Minnesota, 55425, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Nancy E Sherwood, PhD

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2010

First Posted

March 4, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 23, 2012

Record last verified: 2012-04

Locations

US(1)