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: 10552602
• 负责人: Tashara Marie Leak
• 金额: $ 12.51万
• 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 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10552602
• 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; Eligibility Determination; Endocrinology; 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; comparison control; cooking; diabetes prevention program; dietary guidelines; efficacy evaluation; ethnic disparity; evidence base; experience; girls; good diet; group intervention; health care availability; health inequalities; high risk; improved; indexing; innovation; lifestyle intervention; live stream; men; mortality; nutrition; participant enrollment; prevent; preventive intervention; primary outcome; programs; racial disparity; 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.

项目摘要 2型糖尿病（T2 DM）是一种与肥胖相关的慢性疾病，严重影响着人们的生活。 黑人少女，这导致T2 DM发病率和死亡率的种族/民族差异 黑人女性的经历。饮食和体力活动可降低T2 DM风险，但黑人青少年 患有T2 DM的女孩也没有达到推荐的标准。青少年生活方式干预主要是 针对糖尿病前期患者（非T2 DM），是糖尿病预防计划的适应， 适度降低T2 DM风险因素。现有T2 DM相关生活方式干预的局限性包括：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 烹饪成分，4）不是文化定制的，5）评估体重指数的变化，但不评估 血糖测量（例如，糖化血红蛋白，口服葡萄糖耐量试验），这是一个直接预测 T2MD对于拟议的研究，我们将检查我们的12周文化定制的初步疗效， 远程健康生活方式干预称为黑人女孩健康（BGW）。这项研究是由社会 认知理论，它假设个人（例如，自我效能），行为（例如，技能）和环境 (e.g.,社会和身体）因素影响行为（例如，饮食和体力活动）和健康结果 (e.g.,身体组成和血糖测量）。每周参与者将参加3项活动：1）现场 流媒体小组营养课程和报到（60分钟/周），2）在家烹饪体验，准备 健康的民族餐，使用通过亚马逊新鲜（60分钟/周）发送的成分，和3）实时流非洲中心 舞蹈课（60分钟，每周3天）。我们将招募超重或肥胖的黑人少女（12-18岁） 纽约长老会-威尔康奈尔医学儿科内分泌诊所的 （曼哈顿，纽约）参加一项初步随机对照试验（RCT）（n=60; 30-干预，30-对照）。 在终点数据收集后，对照组将参与BGW。建议的研究是创新的 通过使用远程保健提供方法，动手烹饪经验和身体活动， 文化定制和血糖测量接近T2 DM风险。美国糖尿病协会 建议远程保健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少女中进行探索。 我们的中心假设是，干预组将经历饮食质量的显着改善 （主要结局）、体力活动、身体成分和血糖测量，与对照组相比 组长期目标是建立一个以证据为基础的，文化上定制的远程糖尿病预防 干预措施，可以扩大，以解决黑人青春期女孩的需要与糖尿病前期，高风险， 服务不足的人口。