FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children

Study Overview
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Brief Summary
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In this 3-phase study, following an initial small-scale (phase 1) feasibility trial, the aim of phase 2 of the project is to investigate whether a community-based, 12-month intervention for overweight and obese preschool children 2-6 years of age and their families will be effective in reducing the participants' degree of overweight (BMI z-score) and in improving quality of life. In the final phase (phase 3), participating children will be randomized to either receiving a multidisciplinary lifestyle intervention during the first 6 months (treatment arm), or 6 months later (control or wait list arm), in order to generate more robust effectiveness data. Participants will receive an additional free 6-month YMCA membership while participating in the study.

Official Title
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FOR HEALTH: A Family-ORiented Healthy Eating, Activity and Lifestyle Training With Hands-on Experience for Overweight and Obese Preschool Children and Their Families - a Pilot Trial.

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 2-6 on study entry with primary overweight or obesity, BMI => 85th percentile for age and sex on 2010 WHO Growth Charts for Canada Family meets Readiness for change criteria, contemplation or higher stage, according to Prochaskas Transtheoretical Model. At least one parent/caregiver committed to attend all the program sessions with the child Parent/caregiver is agreeing to complete the study questionnaires at the required time points Exclusion Criteria: Chronic medical conditions potentially impacting program participation or associated with a potentially increased risk in participation (e.g. type 1 diabetes mellitus, heart-, gastrointestinal-, or kidney diseases, uncontrolled asthma, other physical, developmental or psychological disabilities that could limit extent of study participation Regular use of medications that could limit extent of study participation Other concurrent or recently (last 12 months)received obesity treatment Inability to read, speak, and/or verbally understand English Living outside of the greater London, Ontario, area

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Secondary lifestyle intervention arm<br>6-month wait list group. Second arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling, following of completion of main 6-month intervention for arm 1. | Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling<br>* Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.<br>|
| Experimental: Primary lifestyle intervention arm<br>First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling | Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling<br>* Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score | Change in BMI z-score | Baseline, 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Scores (PedsQL 4.0) | Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6). | Baseline, 3, 6, 9, 12 months | 
| Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ) |  | Baseline, 3, 6, 9, 12 months | 
| Change in parent-reported daily screen-time (TV, computer) | Parent-reported daily screen-time, estimated to the nearest 15 minutes. | Baseline, 3, 6, 9, 12 months | 
| Change in fruit & vegetable consumption assessed by 3-day food records |  | Baseline, 3, 6, 9, 12 months | 
| Change in dairy-product consumption assessed by 3-day food records |  | Baseline, 3, 6, 9, 12 months | 
| Change in grain-product consumption assessed by 3-day food records |  | Baseline, 3, 6, 9, 12 months | 
| Change in consumption of sugar-sweetened beverages assessed by 3-day food records |  | Baseline, 3, 6, 9, 12 months | 
| Change in percent overBMI | Percent overBMI is the percentage above the 50th percentile of BMI for the respective age and gender [(BMI-BMI at 50th percentile)]/BMI at 50th percentile]*100 | Baseline, 3, 6, 9, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood obesity, multidisciplinary, preschool children, community-based, lifestyle intervention, family-centered