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

Not Applicable

Terminated

• Conditions: Childhood Obesity
• Interventions: Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling

• Registration Number: NCT01698606
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-03
• Study Start: 2013-01
• Primary Completion: 2019-04-15
• Study Completion: 2019-04-15
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Secondary lifestyle intervention arm	Multidisciplinary, family-centered lifestyle intervention with behavioral counseling	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.
Primary lifestyle intervention arm	Multidisciplinary, family-centered lifestyle intervention with behavioral counseling	First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling

Primary Outcome Measures

Name	Time	Method
BMI z-score	Baseline, 3, 6, 9, 12 months	Change in BMI z-score

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life Scores (PedsQL 4.0)	Baseline, 3, 6, 9, 12 months	Instrument used: PedsQL 4.0 Generic Core Scales, parent report, for toddlers (age 2-4), or for young children (age 5-6).
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)	Baseline, 3, 6, 9, 12 months	Parent-reported daily screen-time, estimated to the nearest 15 minutes.
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	Baseline, 3, 6, 9, 12 months	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

Trial Locations

Locations (1)

Children's Hospital, London Health Sciences Centre, University of Western Ontario; 🇨🇦 London, Ontario, Canada