Clinical trial NCT01698606: FOR HEALTH: A Family-oriented Healthy Eating, Activity and Lifestyle Intervention for Overweight Preschool Children
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Childhood Obesity
Keywords: childhood obesity
multidisciplinary
preschool children
community-based
lifestyle intervention
family-centered
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-10-03
Enrollment: 11
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: BMI z-score
timeFrame: Baseline, 3, 6, 9, 12 months
Secondary outcomes:
measure: Change in Quality of Life Scores (PedsQL 4.0)
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Change in physical activity score (Netherlands Physical Activity Questionnaire for Young Children, NPAQ)
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Change in parent-reported daily screen-time (TV, computer)
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Change in fruit & vegetable consumption assessed by 3-day food records
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Change in dairy-product consumption assessed by 3-day food records
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Change in grain-product consumption assessed by 3-day food records
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Change in consumption of sugar-sweetened beverages assessed by 3-day food records
timeFrame: Baseline, 3, 6, 9, 12 months
measure: Change in percent overBMI
timeFrame: Baseline, 3, 6, 9, 12 months
Other outcomes:
measure: Change in parental BMI (kg/m2)
timeFrame: Baseline, 3, 6, 9, 12 months
Locations:
city: London
country: Canada
facility: Children's Hospital, London Health Sciences Centre, University of Western Ontario
state: Ontario
Study officials:
affiliation: University of Western Ontario, Canada
name: Dirk E. Bock, M.D.
role: PRINCIPAL_INVESTIGATOR
References: