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

Childhood Obesity Clinical Trial

— FOR HEALTH  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01698606
• Other study ID #: 103011
• Status: Terminated
• Phase: N/A
• Start date: January 2013
• Est. completion date: April 15, 2019

Study information

• Verified date: May 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Childhood Obesity
• Overweight
• Pediatric Obesity

Intervention

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.

Locations

Country	Name	City	State
Canada	Children's Hospital, London Health Sciences Centre, University of Western Ontario	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	BMI z-score	Change in BMI z-score	Baseline, 3, 6, 9, 12 months
Secondary	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
Secondary	Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)		Baseline, 3, 6, 9, 12 months
Secondary	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
Secondary	Change in fruit & vegetable consumption assessed by 3-day food records		Baseline, 3, 6, 9, 12 months
Secondary	Change in dairy-product consumption assessed by 3-day food records		Baseline, 3, 6, 9, 12 months
Secondary	Change in grain-product consumption assessed by 3-day food records		Baseline, 3, 6, 9, 12 months
Secondary	Change in consumption of sugar-sweetened beverages assessed by 3-day food records		Baseline, 3, 6, 9, 12 months
Secondary	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