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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Childhood Obesity
• Intervention / Treatment: Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • Children's Hospital, London Health Sciences Centre, University of Western Ontario

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Secondary lifestyle intervention arm; 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; 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.
Experimental: Primary lifestyle intervention arm; First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling	Behavioral: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parental BMI (kg/m2)	Assessment of change in BMI of the caregiver primary attending the intervention with the child.	Baseline, 3, 6, 9, 12 months

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Investigators: Principal Investigator: Dirk E. Bock, M.D., University of Western Ontario, Canada

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: childhood obesity; preschool children; community-based; lifestyle intervention; multidisciplinary; family-centered
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight
• Other Study ID Numbers: 103011