Healthy Frio: A Rural Community Partnership to Advance Latino Obesity Research

 描述（由申请人提供）：关于全面的健康生活方式干预措施减少肥胖的功效和有效性已经了解了很多，但很少有研究被转化为农村环境或拉丁美洲人。Y Living是一项以证据为基础的以家庭为中心的干预措施（FI），由PI博士Deborah Parra-Medina和她的南德克萨斯州研究团队为城市拉丁裔家庭设计。FI是一项为期12周的行为改变计划，以行为改变的社会认知理论为基础，旨在通过发展体育活动和健康饮食的知识和技能，建立目标设定和自我监控的技能，以及在家中创造支持性环境，使整个家庭参与生活方式的改变。研究人员将参与社区合作伙伴的形成性研究，以适应目前的FI为农村拉丁裔家庭。将开发和测试两种并行的FI交付方法：1）在社区中心（FI-IP）和2）基于家庭的远程技术交付（FI-RT）。虽然两者都将旨在解决农村拉丁裔家庭面临的独特的社会，文化和环境因素，后者利用创新的现代技术和电子学习，以增加方案的可用性，可访问性和方案参与农村环境。我们将进行一项3臂随机对照试验，以比较两种分娩方法在肥胖拉丁美洲父母-子女对与对照组之间对体重减轻（主要结局）和能量平衡行为（次要结局）的有效性。我们将从德克萨斯州南部农村的三个初级保健诊所招募270名肥胖（BMI 30-39.9kg/m2）拉丁美洲成年人（年龄21-65岁）和一名儿童（年龄8-17岁）。这270对父母-孩子将被随机分配到按诊所分层的三个组之一：1）FI-IP （n=90）; 2）FI- RT（n=90）;或3）对照组（n=90）。本研究的主要具体目的是：1）进行社区参与的形成性研究，将现有的以家庭为中心的干预（FI）转变为两种独特的实施方法（FI-IP和FI-RT）用于随后在农村拉丁裔社区进行的随机对照试验; 2）进行随机对照试验，以评估两种平行分娩方式的家庭干预的比较效果（FI-IP和FI-RT），以解决肥胖的农村拉丁美洲成年人与对照组成年参与者在干预后立即（3个月），再次在3个月的维持计划（随机化后6个月）和6个月随访（随机化后12个月）的体重减轻（主要结局）和能量平衡行为（次要结局）。第二个目的是检查FI-IP和FI-RT儿童的体重和能量平衡行为的影响。

 DESCRIPTION (provided by applicant): Much has been learned about the efficacy and effectiveness of comprehensive healthy lifestyle interventions to reduce obesity, but few studies have been translated into rural settings or among Latinos. Y Living is an evidence-based family-focused intervention (FI) designed for urban Latino families by PI Dr. Deborah Parra-Medina and her South Texas-based research team. The FI is a 12-week behavioral modification program grounded in the social cognitive theory of behavior change designed to engage the whole family in lifestyle changes by developing knowledge and skills in physical activity and healthy eating, building skills in goal-setting and self- monitoring, and creating a supportive environment at home. Researchers will engage community partners in formative research to adapt the current FI for rural Latino families. Two parallel delivery methods of the FI will be developed and tested: 1) in-person group setting at a community center (FI-IP) and 2) home-based delivered remotely with technology (FI-RT). While both will be designed to address the unique social, cultural and environmental factors facing rural Latino families, the latter takes advantage of innovative modern technology and e-Learning to increase program availability, accessibility and program participation in rural settings. We will conduct a 3-arm randomized controlled trial to compare the effectiveness of the two delivery approaches on weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese Latino parent-child pairs versus control. We will recruit 270 obese (BMI 30-39.9kg/m2) Latino adults (ages 21-65) with a child (ages 8-17) from three primary care practices in rural South Texas. These 270 parent-child pairs will be randomized to one of three arms stratified by clinic: 1) FI-IP (n=90); 2) FI- RT (n=90); or 3) control group (n=90). The primary specific aims of the study are to: 1) Conduct community-engaged formative studies to transform the existing family-focused intervention (FI) into two unique delivery methods (FI-IP and FI-RT) for use in a subsequent randomized controlled trial in a rural Latino community; and 2) Conduct a randomized controlled trial to evaluate the comparative effectiveness of two parallel delivery methods of family-focused intervention (FI-IP and FI-RT) to address weight loss (primary outcome) and energy balance behaviors (secondary outcomes) among obese rural Latino adults compared with adult participants in control group at immediate post intervention (3 months), again after a 3-month maintenance program (6 months post randomization) and a 6-month follow-up (12 months post randomization). A secondary aim is to examine the impact of FI-IP and FI-RT children's weight and energy balance behaviors.