The preliminary efficacy of a culturally tailored, telehealth lifestyle intervention for Black adolescent girls with prediabetes: a pilot randomized controlled trial

针对患有糖尿病前期的黑人青春期女孩进行文化定制的远程健康生活方式干预的初步效果：一项随机对照试验

• 批准号: 10354327
• 负责人: Tashara Marie Leak
• 金额: $ 32.19万
• 依托单位: CORNELL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-19 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10354327
• 关键词: Accelerometer; Address; Adherence; Adolescent; American; Area; Behavioral; Black race; Body Composition; Body mass index; Childhood; Chronic Disease; Clinic; Community Health; Control Groups; Dancing; Data; Data Collection; Diabetes Mellitus; Diabetes prevention; Diet; Diet Records; Dose; Educational Curriculum; Endocrinology; Enrollment; Ethnic Origin; Female Adolescents; Glycosylated Hemoglobin; Goals; Health; Health Food; Health Sciences; Healthy Eating; Hispanic; Home; Incidence; Intervention; Interview; Measures; Medicine; Methods; National Institute on Minority Health and Health Disparities; New York; Non-Insulin-Dependent Diabetes Mellitus; Not Hispanic or Latino; OGTT; Obesity; Outcome; Outcome Measure; Overweight; Participant; Perception; Physical activity; Population Sciences; Prediabetes syndrome; Presbyterian Church; Prevalence; Program Acceptability; Race; Randomized; Randomized Controlled Trials; Recommendation; Research Priority; Risk; Risk Factors; Sampling; Self Efficacy; System; Underserved Population; Woman; Youth; acceptability and feasibility; behavior change; behavior influence; black women; boys; cooking; diabetes prevention program; dietary guidelines; efficacy evaluation; evidence base; experience; girls; good diet; group intervention; health care availability; high risk; improved; indexing; innovation; lifestyle intervention; live stream; men; mortality; nutrition; prevent; preventive intervention; primary outcome; programs; racial and ethnic disparities; recruit; response; service delivery; skills; social; social cognitive theory; telehealth; theories; treatment as usual; virtual delivery

PROJECT SUMMARY Type 2 diabetes mellitus (T2DM), an obesity-related chronic disease, disproportionally impacts the lives of Black adolescent girls, which contributes to racial/ethnic disparities in T2DM incidence and mortality rates experienced by Black women. Diet and physical activity are shown to reduce T2DM risk, but Black adolescent girls with T2DM are not meeting recommendations for either. Lifestyle interventions for adolescents primarily target those with prediabetes (not T2DM), are adaptations of the Diabetes Prevention Program, and only modestly reduce T2DM-risk factors. Limitation of existing T2DM-related lifestyle interventions include: 1) barriers to program participation, 2) barriers to making and sustaining behavior changes, 3) do not include a cooking component, 4) are not culturally tailored, and 5) evaluate changes in body mass index but not in glycemic measures (e.g., glycated hemoglobin, oral glucose tolerance test), which is a direct predictor of T2MD. For the proposed study, we will examine the preliminary efficacy of our 12-week culturally tailored, telehealth lifestyle intervention called Black Girls for Wellness (BGW). The study is informed by the Social Cognitive Theory, which posits that personal (e.g., self-efficacy), behavioral (e.g., skills), and environmental (e.g., social and physical) factors influence behaviors (e.g., diet and physical activity) and health outcomes (e.g., body composition and glycemic measures). Each week participants will engage in 3 activities: 1) a live stream group nutrition lesson and check-in (60 min/week), 2) a cooking experience at home preparing a healthy ethnic meal using ingredients sent via Amazon Fresh (60 min/week), and 3) live stream Afrocentric dance classes (60 min 3 days/week). We will recruit Black adolescent girls (12-18 y) with overweight or obesity and prediabetes from the New York Presbyterian-Weill Cornell Medicine Pediatric Endocrinology Clinic (Manhattan, NY) to participate in a pilot randomized controlled trial (RCT) (n=60; 30-intervention, 30-control). After end-point data collection, the control group will participate in the BGW. The proposed study is innovative through the use of telehealth delivery methods, hands on cooking experiences and physical activity that are culturally tailored, and glycemic measures that are proximal to T2DM risk. The American Diabetes Association recommends telehealth and culturally tailored lifestyle interventions to address systems level inequities in healthcare access, yet these methods have yet to be explored with Black adolescent girls with prediabetes. Our central hypothesis is that the intervention group will experience significant improvements in diet quality (primary outcome), physical activity, body composition, and glycemic measures, as compared to the control group. The long-term goal is to establish an evidence-based, culturally tailored, telehealth diabetes prevention intervention that can be scaled to address the needs of Black adolescent girls with prediabetes, a high risk and underserved population.

项目总结 2型糖尿病(T2 DM)是一种与肥胖相关的慢性疾病，它不成比例地影响着 黑人少女，这导致了2型糖尿病发病率和死亡率的种族/族裔差异 黑人女性所经历的。饮食和体力活动被证明可以降低患2型糖尿病的风险，但黑人青少年 患有T2 DM的女孩没有达到这两个标准的推荐标准。主要针对青少年的生活方式干预 以糖尿病前期患者(非T2 DM)为目标，是糖尿病预防计划的改编，并且仅 适度降低2型糖尿病的危险因素。现有与T2 DM相关的生活方式干预措施的局限性包括：1) 参与计划的障碍，2)进行和维持行为改变的障碍，3)不包括 烹饪部分，4)没有文化上的量身定制，5)评估体重指数的变化，而不是 血糖测量(例如，糖化血红蛋白、口服葡萄糖耐量试验)，这是一种直接预测 T2MD。对于拟议的研究，我们将检查我们12周的文化定制的初步效果， 远程健康生活方式干预被称为黑人女孩健康(BGW)。这项研究由社会福利机构提供信息 认知理论，它假设个人(例如自我效能)、行为(例如技能)和环境 (如社会和身体)因素影响行为(如饮食和体力活动)和健康结果 (例如，身体成分和血糖测量)。每周参与者将参与3项活动：1)现场直播 Stream Group营养课和签到(每周60分钟)，2)在家准备烹饪体验 使用通过Amazon Fresh(每周60分钟)发送的食材的健康民族餐，以及3)Afrom Centrate直播流 舞蹈课(每周3天，每次60分钟)。我们将招募超重或肥胖的黑人少女(12-18岁) 和来自纽约长老会-威尔·康奈尔医学院儿科内分泌学诊所的糖尿病前期 (纽约曼哈顿)参加试点随机对照试验(RCT)(n=60；30-干预，30-对照)。 终点数据采集完成后，对照组参加BGW。建议的研究具有创新性。 通过使用远程保健交付方法，亲身体验烹饪体验和身体活动 文化上量身定做的，以及接近T2 DM风险的升糖措施。美国糖尿病协会 建议远程医疗和文化定制的生活方式干预措施，以解决系统层面的不平等 然而，这些方法尚未在患有糖尿病前期的黑人青春期女孩中探索。 我们的中心假设是，干预组的饮食质量将有显著改善 (主要结果)、体力活动、身体成分和血糖测量，与对照组相比 一群人。长期目标是建立以证据为基础的、文化上量身定做的远程保健糖尿病预防 可扩大规模的干预措施，以满足患有糖尿病前期、高风险和 服务不足的人口。