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.

项目摘要 2型糖尿病（T2DM）是一种与肥胖相关的慢性疾病，对 黑人青春期女孩，这导致T2DM发病率和死亡率的种族/种族差异 由黑人妇女体验。饮食和体育锻炼显示可降低T2DM风险，但黑色青少年 具有T2DM的女孩都不满足任何建议。青少年的生活方式干预主要是 针对糖尿病前（而不是T2DM）的人，是预防糖尿病计划的适应 适度减少T2DM风险因素。现有T2DM相关生活方式干预措施的限制包括：1） 计划参与的障碍，2）进行和维持行为改变的障碍，3）不包括 烹饪成分，4）不适合文化量身定制，5）评估体重指数的变化，但不能 血糖措施（例如，糖化血红蛋白，口服葡萄糖耐量测试），这是直接预测因子 T2MD。在拟议的研究中，我们将研究我们12周的文化量身定制的初步功效， 远程医疗生活方式干预称为黑人女孩（BGW）。该研究由社会告知 认知理论提出了个人（例如自我效能），行为（例如技能）和环境 （例如，社会和身体）因素影响行为（例如饮食和体育锻炼）和健康结果 （例如，身体成分和血糖措施）。每周参与者将参加3个活动：1）现场直播 溪流集团营养课和办理登机手续（60分钟/周），2）在家准备的烹饪体验 使用亚马逊新鲜（60分钟/周）和3）现场溪流以非洲为中心的成分的健康餐食 舞蹈课（60分钟3天/周）。我们将以超重或肥胖症招募黑人青春期女孩（12-18岁） 和纽约长老会康奈尔医学小儿内分泌诊所的糖尿病 （纽约州曼哈顿）参加一项飞行员随机对照试验（RCT）（n = 60; 30个干预，30-Control）。 终点数据收集后，对照组将参加BGW。拟议的研究是创新的 通过使用远程医疗交付方法，动手烹饪体验和体育锻炼 具有文化量身定制和邻近T2DM风险的血糖措施。美国糖尿病协会 建议远程医疗和文化量身定制的生活方式干预措施，以解决系统水平不平等 医疗保健的访问，但是这些方法尚未与糖尿病前期的黑人青春期女孩进行探索。 我们的核心假设是干预组将在饮食质量方面取得重大改善 （主要结果），体育活动，身体成分和血糖措施与对照相比 团体。长期目标是建立一个基于循证的，具有文化量身定制的远程医疗糖尿病的预防 可以缩放的干预措施，以满足黑人青春期女孩的需求，高风险和高风险和 服务不足的人口。