Healthy Homes/Healthy Kids Preschool

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Healthy Homes/Healthy Kids_5-9

NCT01084590

Obesity Injury

COMPLETED NA

Environmental Influences on Early Childhood Obesity

NCT02703688

Childhood Obesity

COMPLETED NA

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

NCT01029834

Overweight

COMPLETED NA

Healthy Bodies Project to Prevent Childhood Obesity

NCT04552678

Obesity, Childhood

COMPLETED NA

The Healthy Families Project

NCT01193374

Childhood Obesity

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The pediatric primary care setting is a relatively untapped resource for addressing obesity prevention. The goals of this developmental study are to develop and evaluate the feasibility and acceptability of a primary care-based, preschool obesity prevention intervention integrating pediatrician counseling and a home-based program for parents of 2-4 year old children at risk for obesity. We propose to recruit 60 parent-child dyads from families of 2-4 year old at risk children (e.g., BMI between the 85th and 95th percentile for age and gender or a BMI between the 50th and 85th percentile and at least one overweight parent) and randomize each dyad to one of the following groups: (a) Healthy Eating/Physical Activity Intervention including brief pediatrician counseling regarding the child's current BMI%ile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction recommendations paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the obesity prevention home environmental strategies, or (b) General Health/Safety/Injury Prevention Contact Control Intervention: Families will receive the same brief counseling from their pediatrician paired with a 6 month home-based program delivered via phone by a health behavior specialist to promote implementation of the general health, safety and injury prevention home environmental strategies.

* Healthy Eating/Physical Activity Home-based Intervention: The "Busy Bodies/Better Bites" intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.
* Safety/Injury Prevention Home-based Contact Control Intervention: The "Healthy Tots/Safe Spots" intervention arm 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Busy Bodies/Better Bites

Healthy Eating/Physical Activity Intervention

Group Type EXPERIMENTAL

Busy Bodies/Better Bites

Intervention Type BEHAVIORAL

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.

Healthy Spots/Safe Tots

Injury Prevention and Safety Intervention

Group Type ACTIVE_COMPARATOR

Healthy Spots/Safe Tots

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Busy Bodies/Better Bites

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.

Intervention Type BEHAVIORAL

Healthy Spots/Safe Tots

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

1. 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.
2. 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.
3. Families who have limited English skills.
4. Families who plan to move out of the metropolitan area within the next six months.

Minimum Eligible Age

2 Years

Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No