Surveillance of Obesity and Pre-Diabetes/Diabetes in Kiritimati School Children and Lifestyle Modifications to Reduce Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 3
- 主要终点
- Change in mean blood glucose (mg/dL)
研究概览
简要总结
Kiritimati is an isolated coral atoll in the Pacific Ocean, and is one of 32 islands that comprise the Republic of Kiribati. Obesity and type 2 diabetes rates are high in Kiribati, but the causes and rates of childhood obesity/diabetes are unknown. However, it has been hypothesized that high consumption of sugar-sweetened beverages on Kiritimati may be a contributing factor. The investigators therefore conducted a study in Kiritimati in September 2018 with the aim of 1) quantifying obesity and diabetes rates amongst children on Kiritimati and 2) testing the feasibility of a sugar-reduction intervention in Kiritimati schools. The investigators randomized the two high schools on the island to either the control group or the intervention group. The investigators measured height/weight, continuous blood glucose (using flash glucose monitoring), and diet (using 24-hour diet recalls). One week into the study, the intervention school received an intervention, which consisted of installation of a water filter at the school, the provision of water bottles to each student at the school, and a 30-minute educational presentation on the link between sugar consumption and type 2 diabetes. The investigators then measured how blood glucose and diet changed the week following the intervention, and compared this to the control school.
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
- None
入排标准
- 年龄范围
- 10 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in one of the two high schools on Kiritimati
排除标准
- •> 18 years of age
结局指标
主要结局
Change in mean blood glucose (mg/dL)
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Mean blood glucose was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in standard deviation (mg/dL) of continuous glucose monitor data
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (standard deviation) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in J-index of continuous glucose monitor data
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (J-index) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in total sugar consumption (g/day) using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total sugar intake between the control and intervention schools (time x group interaction).
Change in percent calories from total sugars consumption using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from total sugars intake between the control and intervention schools (time x group interaction).
Change in sugary beverage (tang) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (fruit drinks) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in mean amplitude of glycemic variability (MAGE) (mg/dL)
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (mean amplitude of glycemic excursions) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in coefficient of variation (percent) of continuous glucose monitor data
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (coefficient of variation (percent) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in added sugar consumption (g/day) using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in added sugar intake between the control and intervention schools (time x group interaction).
Change in total water consumption (g/day) using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total water intake between the control and intervention schools (time x group interaction).
Change in percent calories from carbohydrate consumption using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from carbohydrate intake between the control and intervention schools (time x group interaction).
Change in sugary beverage (ice block) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in area under the curve of continuous glucose monitor data
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
A continuous glucose monitor was attached to all participants, which collected data for 2 weeks. Glycemic variability (area under the curve) was calculated for each participant using GlyCulator, an online tool for analyzing CGM data.
Change in total carbohydrate (g/day) consumption using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in total carbohydrate intake between the control and intervention schools (time x group interaction).
Change in sugary beverage (juice) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in energy (kcal/day) consumption using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in energy (kcal) intake between the control and intervention schools (time x group interaction).
Change in percent calories from added sugars consumption using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in % calories from added sugars intake between the control and intervention schools (time x group interaction).
Change in sugary beverage (toddy) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (soda) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in unsweetened water consumption (servings/day) using 24-hour dietary recalls
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted 24-hour diet recalls and entered data into the NDSR database for comparison of change in unsweetened water intake between the control and intervention schools (time x group interaction).
Change in sugary beverage (tioka) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
Change in sugary beverage (coffee/tea) consumption using beverage frequency questionnaires
时间窗: 2 weeks (1 week pre- and 1 week post-intervention)
The investigators conducted beverage frequency questionnaires which asked about consumption of popular beverages on Kiritimati (specifically: "how many days per week do you typically drink this drink?" and "how much each day?") then compared change pre-and post-intervention between the two groups (time x group interaction) in servings/day.
次要结局
未报告次要终点
研究者
Elizabeth Beale
Assistant Professor
University of Southern California