Reducing Sugared Fruit Drinks in Alaska Native Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 334
- 试验地点
- 2
- 主要终点
- Change in Added Sugar Intake Among Children
研究概览
简要总结
This study in Alaska will test whether providing sugar-free alternatives to sugared fruit drinks and introducing education and social support will help families and children to reduce the amount of sugared fruit drinks consumed (measured through the primary outcome of added sugar intake).
详细描述
Alaska Native children consume an average of 50 teaspoons of sugar per day and most of this added sugar is from fruit drinks like Tang and Kool-Aid. The goal of this community-based behavioral trial is to reduce added sugar intake in Alaska Native children. In Communities A and B, a total of 136 children ages 1-11 years will be recruited for a 6-month culturally-adapted, 5-session intervention consisting of video-based health education and self-efficacy coaching delivered in person by an indigenous Community Health Worker. There will be 4 brief "check-ins" to provide social support. Local stores have been recruited to carry sugar-free fruit drinks. In Community C, 56 children will be recruited to a no treatment control group. Outcomes will be measured at baseline, 1, 3, 6, and 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
All raw data provided to the statistician will include a participant-level variable indicating the community in which the participant lives.
入排标准
- 年龄范围
- 1 Year 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child must be older than age 1 year but less than age 12 years at time of enrollment. Multiple children from the same family are eligible;
- •Child must live in one of the study communities at baseline;
- •Child's parent or primary caregiver must of Yup'ik descent, be age 18 years or older, and willing to provide written consent to study procedures;
- •Child participant(s) ages 8 to 11 years must be willing to provide written assent to study procedures;
- •Willing to comply with all study procedures and be available for the duration of the study.
排除标准
- •Severe medical condition that would prevent the child from completing the study procedures;
- •Allergy to sucralose or acesulfame potassium (sweeteners in the sugar-free water enhancers) as defined by parent report of any known allergies;
- •Sulfa drug allergy (potential hypersensitivity to acesulfame potassium);
- •Member of the same household as the Community Health Worker who will be delivering the intervention.
结局指标
主要结局
Change in Added Sugar Intake Among Children
时间窗: Baseline to 6 months
Added sugar intake among children will be measured with a validated hair biomarker, generated from stable carbon and nitrogen isotope ratios of hair using coefficients for added sugar determined specifically for the Yup'ik population. The investigators will measure added sugar in grams of added sugar per day.
次要结局
- Change in Added Sugar Intake Among Caregivers(Baseline to 6 months)
研究者
Donald Chi
Professor, Oral Health Sciences
University of Washington