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.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Childhood Obesity
- Sponsor
- Lawson Health Research Institute
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- BMI z-score
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
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.
Investigators
Dirk Bock
Principal Investigator
Lawson Health Research Institute
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
Outcomes
Primary Outcomes
BMI z-score
Time Frame: Baseline, 3, 6, 9, 12 months
Change in BMI z-score
Secondary Outcomes
- Change in Quality of Life Scores (PedsQL 4.0)(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)(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(Baseline, 3, 6, 9, 12 months)