Not provided
Not provided
Not provided
Not provided
Phase 1 (Feasibility) completed. Currently no funding to launch Phase 2 (RCT).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secondary lifestyle intervention arm | Active Comparator | 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. |
|
| Primary lifestyle intervention arm | Experimental | First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multidisciplinary, family-centered lifestyle intervention with behavioral counseling | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| BMI z-score | Change in BMI z-score | Baseline, 3, 6, 9, 12 months |
| 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) |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Dirk E. Bock, M.D. | University of Western Ontario, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, London Health Sciences Centre, University of Western Ontario | London | Ontario | N6A 5W9 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided