Healthy Children, Strong Families: American Indian Communities Preventing Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 10
- 主要终点
- Change in child adiposity from baseline measured via BMI z-score
研究概览
简要总结
Healthy Children, Strong Families-2 (HCSF-2) is a family focused early childhood intervention which addresses the growing problem of childhood obesity in American Indian communities. The study works with six rural and urban American Indian communities across the US to test the ability of the intervention to increase adoption of healthy lifestyles and to reduce the prevalence of obesity among preschool aged American Indian children and their primary caregivers - creating healthier children, healthier families and healthier communities. Our primary hypothesis is that children and their primary caregivers who receive the HCSF-2 intervention will have better obesity related outcomes than those who do not receive HCSF-2.
详细描述
Intervention
The Healthy Children, Strong Families-2 (HCSF-2) intervention consists of monthly mailed healthy lifestyle lessons (13 lessons) which will be dose enhanced with social networking support (cell-phone coaching with instant text messages and Facebook connections), as well as new intervention elements-stress and sleep. Social networking was chosen due to its widespread and ease of use, adaptability and potential for sustainability in the community.
HCSF-2 is based on our hypothesis that working with children and their primary caregivers/parent to assist them in making healthy lifestyle changes is necessary to prevent excessive weight gain and risk of later lifestyle related chronic disease. Investigators will work with families at a critical time in their young child's physical and emotional development to encourage appropriate healthy lifestyle behaviors.
This study will expand on our previous research to test the HCSF-2 intervention in a larger, more geographically and socially diverse sample of AI communities. The study also enhances the prior methodology through the inclusion of a social networking component. This research will address four key gaps in obesity prevention studies: families with preschool age children, social networking support, stress and sleep. Moreover, to our knowledge, this study will be the first family-based obesity intervention project for both rural and urban AI families. The potential impact of this study is high; if successful, this study will not only provide quantitative evidence of the effectiveness of the intervention but it will also give other investigators validated tools and procedures to collaboratively engage AI communities in health behavior change.
Year 1, families will be randomized to start in the HCSF-2 intervention or an active control (mailed child safety newsletters). Then, in Year 2, intervention change will occur, such that HCSF-2 intervention families will receive the control safety lessons plus continued HCSF-2 social networking, while control families will now receive the full HCSF-2 intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (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
- •Adult caregiver with a 2-5 year old child
- •2-5 year old child with a caregiver
- •Caregiver has a working cell phone and is willing to receive regular text messages as part of study participation
- •Caregiver lives within feasible travel distance of data collection site and willing to come for data collection visits at 0, 6 months, 12 months, 18 months and 24 months
- •Willingness to be randomized to one of two groups with the understanding that all participants will receive all components of the intervention, randomization simply determines the order in which materials are received
- •Valid mailing address where participant can receive mail and packages
- •Basic English fluency and literacy sufficient for understanding the intervention materials and completing questionnaires
排除标准
- •Adults with no children or whose only children are younger than 2 or older than 5
- •Children younger than 2 or older than 5 years of age
- •No cell phone or unwilling to receive regular text messages as part of study participation
- •Lives beyond feasible travel distance of data collection sites AND/OR planning on moving out of the area within a two year period
- •Child has major physical or behavioral disorder (e.g. failure to thrive, severe autism) that would seriously impact study participation
- •No valid mailing address
- •Unwillingness to accept random allocation to study arm
- •Spouse/partner of another caregiver-child pair who is living in same home & who has already enrolled (e.g. only one adult-child pair per household may be enrolled)
研究组 & 干预措施
Healthy Children, Strong Families (first)
Healthy Children, Strong Families intervention (first). This is a series of monthly educational tool kits mailed to primary caregivers for use with the participating child. This arm crosses over to receive the Child Safety in Year 2.
干预措施: Healthy Children, Strong Families (Behavioral)
Healthy Children, Strong Families (first)
Healthy Children, Strong Families intervention (first). This is a series of monthly educational tool kits mailed to primary caregivers for use with the participating child. This arm crosses over to receive the Child Safety in Year 2.
干预措施: Child Safety (Behavioral)
Child Safety (first)
A series of 12 monthly newsletters and providing education on child safety mailed to primary caregivers. This Arm crosses over to receive the Healthy Children, Strong Families intervention in Year 2.
干预措施: Healthy Children, Strong Families (Behavioral)
Child Safety (first)
A series of 12 monthly newsletters and providing education on child safety mailed to primary caregivers. This Arm crosses over to receive the Healthy Children, Strong Families intervention in Year 2.
干预措施: Child Safety (Behavioral)
结局指标
主要结局
Change in child adiposity from baseline measured via BMI z-score
时间窗: Enrollment, 6 months, 12 months, 18 months, 24 months
BMI z-score is obtained by computing the BMI weight (in kg)/height (in m)\*height (in m). BMI is then converted to a z-score based on US national norms for gender and age in months provided
Change in adult adiposity from baseline measured via BMI
时间窗: Enrollment, 12 months, 24 months
Adult BMI is computed from weight (in kg) divided by height (in m) squared
次要结局
- Change in amount of adult physical activity from basline(Enrollment, 12 months, 24 months)
- Change in adult fruit and vegetable consumption from basline(Enrollment, 12 months, 24 months)
- Change in amount of child physical activity from baseline(Enrollment, 12 months, 24 months)
- Change in adult sleep pattern from basline(Enrollment, 12 months, 24 months)
- Change in adult adiposity from baseline measured via waist circumference(Enrollment, 12 months, 24 months)
- Change in amount of adult screen time from basline(Enrollment, 12 month, 24 month)
- Change in home environment from basline(Enrollment, 12 months, 24 months)
- Change in adult SF-12 scores from basline(Enrollment, 12 months, 24 months)
- Change in amount of child screen time from basline(Enrollment, 12 month, 24 month)
- Change in child adiposity from baseline measured via waist circumference(Enrollment, 6 months, 12 months, 18 months, 24 months)
- Change in child fruit and vegetable consumption from baseline(Enrollment, 12 months, 24 months)
- Change in adult Readiness to Change from basline(Enrollment, 6 months, 12 months, 18 months, 24 months)
- Stress questionnaire(Enrollment, 12 months, 24 months)
- Change in child sleep pattern from basline(Enrollment, 12 months, 24 months)