Pilot Study of a Home-based Program to Promote Healthy Diet and Activity in Rural-dwelling Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in Fruit and Vegetable Intake (carotenoid concentration) at 7 months
研究概览
简要总结
The study proposes a randomized pilot and feasibility study of a lifestyle modification program to promote healthy diet and activity in rural-dwelling children to reduce Type 2 Diabetes risks.
Intervention participants will receive 6 months of programming to include:
- 16 activity packs;
- 9 health coach sessions;
- unlimited access to a resource toolbox.
Control participants will receive 6 activity packs promoting science, technology, engineering, and math (STEM) learning and 6 check-in calls to support retention.
详细描述
The rising prevalence of obesity and type 2 diabetes (T2D) at increasingly younger ages compels development of new strategies to combat these preventable conditions. Healthy diet and activity are critical to reducing risk, yet these behaviors decline starting in childhood. These trends are most troubling in rural areas, where youth consume more calories and sugar-sweetened beverages but less fruit and whole grains; engage in less physical activity; and are more likely to have overweight or obesity than urban peers. Given unhealthy behaviors are set by adolescence, promoting healthy diet and activity in rural children is crucial to reducing rural-urban disparities in obesity and T2D across the lifecourse.
The investigators have developed a multi-component, family-based intervention to improve diet and activity in children at risk of youth-onset obesity and T2D. The pilot study will gather necessary and sufficient data on feasibility, acceptability, and effect size to finalize the design of a clinical trial.
The investigators will recruit 60 English- or Spanish-speaking children in 2nd to 5th grades from rural communities in Colorado or North Carolina. Participants will be randomized to 6 months of intervention or control programming. Intervention participants will receive approximately 25 hours of programming over 6 months through a) 16 self-contained, parent-guided activity kits, b) 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach, and c) unlimited access to a resource toolbox. Control participants will receive 6 activity kits promoting science, technology, engineering, and math (STEM) learning and will receive 6 check-in calls to support retention.
Standardized measures will be collected at 0 and 7 months. Qualitative interviews will also be conducted at 7 months. Process measures will be tracked by staff throughout the study. With positive results, this innovative pilot study will form the foundation of a clinical trial to evaluate the sustained impact of an at-home, family-based intervention to promote diet and activity in rural children, which can subsequently be disseminated and implemented among the 13 million children living in rural US settings and reduce T2D risks.
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
- Single (Outcomes Assessor)
盲法说明
Data collectors will be blinded to the participant's assigned group.
入排标准
- 年龄范围
- 7 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •7-to-10-years-old
- •Living in rural Colorado or rural North Carolina
- •English- or Spanish-speaking
- •Has 1 parent or primary caregiver willing to actively participate
排除标准
- •Medical diagnosis of diabetes
- •Serious child or parent health concerns that would interfere with participation
- •Plans to move out of the area during the study period
- •Lives with another child who previously participated in the study
研究组 & 干预措施
Intervention Group
Intervention participants will receive approximately 25 hours of programming (over a 6-month period) related to the promotion of physical activity and healthy diet through:
- 16 self-contained, parent-guided activity kits,
- 9 one-on-one health coach/support sessions in-person or virtual by a trained health coach,
- unlimited access to a resource toolbox.
干预措施: Bennett Kids PowerUP Project (Behavioral)
Control Group
Control group programming consists of:
- 6 parent-guided activity kits focused on STEM activities,
- 6 monthly check-in calls to support retention.
The investigators will use Home Science Lab STEM kits designed for English- and Spanish-speaking children aged 6-11 years. The STEM kits do not include any physical health content. Kits will be mailed monthly to the participants' home. To maximize retention in the control group, staff will contact participants each month to confirm the kit was received, encourage completion of the kits, ask about their experience, and answer questions.
结局指标
主要结局
Change in Fruit and Vegetable Intake (carotenoid concentration) at 7 months
时间窗: Month 7
Use the Veggie Meter (Longevity Link, Salt Lake City, UT) to assess carotenoids, a biomarker of fruit and vegetable intake. The device estimates total dermal carotenoid concentration by illuminating the fingertip with a blue wavelength laser light and detecting vibrational/rotational energy levels of molecules, correcting for hemoglobin and melanin levels.
Change in Sugar-Sweetened Beverage Intake (carbon isotope ratio) at 7 months
时间窗: Month 7
Collect red blood cells to measure the carbon isotope ratio, a biomarker of sugar-sweetened beverage intake. Samples will be analyzed via continuous-flow isotope ratio mass spectrometry at the University of Alaska Stable Isotope Facility.
Change in Dietary Intake (MyPyramid Equivalents) at 7 months
时间窗: Month 7
Diet will be assessed with 24-hour dietary recalls using the Automated Self Administered system (ASA24). This system uses the USDA multiple-pass method to query all foods and supplements consumed in the prior 24 hours and produces daily and individual food estimates for macronutrients, micronutrients, and MyPyramid Equivalents (such as servings of vegetables, fruits, whole grains, solid fats, and added sugars).
次要结局
- Change in Screen Time at 7 months(Month 7)
- Change in Physical Activity at 7 months(Month 7)