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

 描述(由申请者提供)：关于综合健康生活方式干预措施减少肥胖的有效性和有效性，人们已经了解了很多，但很少有研究被转化到农村环境或拉丁美洲人中。Y Living是一项基于证据的家庭干预(FI)，由PI博士Deborah Parra-Medina和她位于南得克萨斯州的研究团队为城市拉丁裔家庭设计。FI是一个为期12周的行为矫正计划，基于行为改变的社会认知理论，旨在通过发展体育活动和健康饮食方面的知识和技能，培养设定目标和自我监控的技能，以及在家里创造支持性环境，让整个家庭参与到生活方式的改变中来。研究人员将让社区合作伙伴参与形成性研究，以使目前的FI适应农村拉丁裔家庭。FI的两种平行交付方法将被开发和测试：1)在社区中心面对面的小组设置(FI-IP)和2)基于家庭的技术远程交付(FI-RT)。虽然两者都将旨在解决农村拉美裔家庭面临的独特社会、文化和环境因素，但后者利用创新的现代技术和电子学习来增加农村地区的方案可获得性、可及性和方案参与度。我们将进行一项三臂随机对照试验，以比较两种分娩方式对肥胖拉丁裔亲子对的体重减轻(主要结果)和能量平衡行为(次要结果)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 30-39.9公斤/平方米)拉丁裔成年人(21-65岁)和一个孩子(8-17岁)。这270对亲子将被随机分配到按临床分层的三组中的一组：1)FI-IP 对照组(n=90)，对照组(n=90)。该研究的主要具体目的是：1)开展社区参与的形成性研究，将现有的以家庭为中心的干预(FI)转变为两种独特的交付方法(FI-IP和FI-RT)，用于随后在农村拉美裔社区进行的随机对照试验；2)进行一项随机对照试验，评估两种平行的以家庭为中心的干预方法(FI-IP和FI-RT)在干预后立即(3个月)、维持计划3个月(随机后6个月)和随访6个月(随机后12个月)后，与对照组成年参与者相比，对肥胖农村拉美裔成年人的体重减轻(主要结果)和能量平衡行为(次要结果)的比较效果。第二个目的是检查FI-IP和FI-RT对儿童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.