Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 246
- 试验地点
- 2
- 主要终点
- Child BMI change post intervention and at short term 6 month follow-up
研究概览
简要总结
This study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (PMH+N: parenting mindfully for health) vs. Control intervention with nutrition education (CTL+N) on parent stress, parenting, health behaviors and child obesity risk. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.
详细描述
This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition counseling (N) versus contact control intervention (C) + nutrition counseling (N), to examine short-term and long term enduring effects of PMH+N to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
participant and outcomes assessor
入排标准
- 年龄范围
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Family with a child between 2-5 years
- •BMI of parent ≥30kg/m2
- •Parents aged 18 yrs or older
- •High parent stress (PSS mean score ≥25)
- •Low income family as determined by HHS Poverty Guidelines
排除标准
- •Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
- •Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
- •Inadequate English proficiency to complete questionnaires.
结局指标
主要结局
Child BMI change post intervention and at short term 6 month follow-up
时间窗: Change from Pre-intervention to post-intervention (week 12) and at 6 month short term follow up
Child height will be measured with a measuring tape. For children, weight and height will be plotted on the CDC growth chart for the child's age to determine the BMI-for-age percentile scores.
Parenting Behavior Change
时间窗: TWT parenting behavior ratings at Baseline Pre-intervention and at post-intervention (week 12)
Observed parenting behavior ratings for increase in positive parenting behaviors in the Toy Wait Task (TWT)
Parent Stress change from Pre to Post intervention
时间窗: Baseline Pre-intervention to Post intervention at 12 weeks
Parent stress measured by the Perceived Stress Scale scores ranging from 0-56 with higher scores indicating more stress.
Child food intake change
时间窗: Baseline Pre-intervention and at post-intervention (week 12)
Parent report of child food frequency questionnaire assessment of frequency of healthy and unhealthy food intake.
次要结局
- Parent Stress change from Post intervention to follow up period over 24-months(Post intervention at 12 weeks to follow-up timepoints at 6-, 12-, 18- and 24- month timepoints)
- Child BMI change at long term term follow-up(Baseline compared to 12-month, 18-month and 24-month timepoint)
- Child food intake change(Baseline Pre-intervention and at post-intervention (week 12))
- Parenting Stress Inventory (PSI)(PSI scores at Baseline Pre-intervention and at post-intervention (week 12) and at follow-ups months 6-, 12-, 18- and 24 month timepoints)