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.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- BMI z-score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Secondary lifestyle intervention arm
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.
干预措施: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling (Behavioral)
Primary lifestyle intervention arm
First arm to receive multidisciplinary, family-centered lifestyle intervention with behavioral counseling
干预措施: Multidisciplinary, family-centered lifestyle intervention with behavioral counseling (Behavioral)
结局指标
主要结局
BMI z-score
时间窗: Baseline, 3, 6, 9, 12 months
Change in BMI z-score
次要结局
- 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)
研究者
Dirk Bock
Principal Investigator
Lawson Health Research Institute