Examining the Preliminary Efficacy of an In-Person Lifestyle Intervention for Black Female Adolescent/Caregiver Dyads at Risk for Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
研究概览
简要总结
The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week in-person lifestyle program.
详细描述
Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: an in-person Wellness Session and an at-home cooking experience using ingredients provided at the Wellness Session.
The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •for adolescent participants:
- •12-18 years of age
- •self-identify as Black or African American
- •have obesity (>=95th percentile BMI)
排除标准
- •for adolescent participants:
- •pregnant or within 3 months postpartum.
- •participated in a formal weight management program within 6 months prior to study.
- •currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function.
- •have previously undergone bariatric surgery.
- •have type 2 diabetes.
- •unable to speak English or have developmental conditions that interfere with ability to communicate.
- •Inclusion Criteria for caregiver participants:
- •18 years or older.
- •proficiency in speaking English.
- •live in the same household as the adolescent who will also be enrolled.
- •prepares the majority (>50%) of meals in the household.
- •Exclusion Criteria for caregiver participants:
- •pregnant or within 3 months postpartum.
- •unable to speak English or have developmental conditions that interfere with ability to communicate.
研究组 & 干预措施
Intervention Adolescent/Caregiver Dyads
Adolescent/Caregiver dyads receive 12-week in-person lifestyle program consisting of a Wellness session, Dance Classes, and an at-home Cooking Experience.
干预措施: Black Girls for Wellness In-Person (Behavioral)
结局指标
主要结局
Change in diet quality of adolescent participants, as measured by the Healthy Eating Index Scores
时间窗: Baseline, 12 weeks [end of study]
Scores are calculated from three 24-hour diet records, range from 0-100. Higher score reflects that higher alignment between one's diet and dietary recommendations from the Dietary Guidelines for Americans.
次要结局
- Change in dermal carotenoids level(Baseline, 12 weeks [end of study])
- Change in percent time sedentary(Baseline, 12 weeks [end of study])
- Change in lipid profile(Baseline, 12 weeks [end of study])
- Change in HbA1c(Baseline, 12 weeks [end of study])
- Change in percent time spent in light activity(Baseline, 12 weeks [end of study])
- Change in percent time spent in moderate to vigorous activity(Baseline, 12 weeks [end of study])
- Change in body mass index(Baseline, 12 weeks [end of study])
- Change in high blood pressure status(Baseline, 12 weeks [end of study])
- Change in body fat percentage(Baseline, 12 weeks [end of study])
- Change in waist circumference(Baseline, 12 weeks [end of study])