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

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.

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01698606
Acronym
FOR HEALTH
Enrollment
11
Registered
2012-10-03
Start date
2013-01-31
Completion date
2019-04-15
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Obesity

Keywords

childhood obesity, multidisciplinary, preschool children, community-based, lifestyle intervention, family-centered

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.

Interventions

BEHAVIORALMultidisciplinary, 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.

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
BMI z-scoreBaseline, 3, 6, 9, 12 monthsChange in BMI z-score

Secondary

MeasureTime frameDescription
Change in Quality of Life Scores (PedsQL 4.0)Baseline, 3, 6, 9, 12 monthsInstrument 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 monthsParent-reported daily screen-time, estimated to the nearest 15 minutes.
Change in fruit & vegetable consumption assessed by 3-day food recordsBaseline, 3, 6, 9, 12 months
Change in grain-product consumption assessed by 3-day food recordsBaseline, 3, 6, 9, 12 months
Change in consumption of sugar-sweetened beverages assessed by 3-day food recordsBaseline, 3, 6, 9, 12 months
Change in percent overBMIBaseline, 3, 6, 9, 12 monthsPercent 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
Change in dairy-product consumption assessed by 3-day food recordsBaseline, 3, 6, 9, 12 months

Other

MeasureTime frameDescription
Change in parental BMI (kg/m2)Baseline, 3, 6, 9, 12 monthsAssessment of change in BMI of the caregiver primary attending the intervention with the child.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026