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临床试验/NCT06080425
NCT06080425已完成不适用

Addressing Intergenerational Obesity and Promoting Healthy Eating and Physical Activity Among Individuals [PIHRK'D] Living With Diabetes in Rural Kentucky

The University of Texas Medical Branch, Galveston1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2023年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
hemoglobin A1c values measured at the five post-baseline follow-up points

研究概览

简要总结

The goal of this feasibility study is to use family units as support to promote nutrition and physical activity of individuals with type 2 diabetes. The main question it aims to answer is:

• How does the family structure impact the health of its members living with type 2 diabetes?

Participants will be asked to;

  • Tell us about their access to food sources and places in the community to engage in physical activity.
  • A nutrition and physical activity plan will be developed for participants and their families to use for 6 months.

详细描述

The proposed project is informed by the National Framework for Health Equity and Well Being, which was recently developed by the Cooperative Extension Service. This framework explicitly acknowledges the multiple levels of influence on health outcomes and the role of Cooperative Extension Service as a mitigator of community-level health inequities. The framework acknowledges factors that contribute to health inequities at various societal levels, including root causes of structural inequity; norms, policies, and practices; and social determinants of health. As individuals flow through multiple sectors of the environment, each is known to have a direct influence individually and collectively. For the proposed grant, the study will focus on how county-level Extension agents (federally funded program) can be used to mitigate health disparities that contribute to intergenerational obesity and T2DM management in rural Kentucky. Community-level factors also impact health outcomes, such as lack of access to healthy, affordable food, as well as availability of health-related resources. Community assets will be gathered using subjective and objective community audits and assessed at the participant level using social network analysis. Societal-level factors include social norms and cultural health beliefs that impact health decision-making within the community, particularly families/households.

Participants will be recruited on a staggered basis from 2 rural counties in Kentucky. Recruitment will be conducted via Extension Offices, word-of-mouth, social media, UK Healthcare outpatient clinics (e.g., internal medicine, family medicine, endocrinology), as well as UK's Barnstable Brown Diabetes and Obesity Center. Once enrolled, participants will be screened by the RD to confirm obesity/overweight, T2DM diagnosis, and identify each participant's placement within the Transtheoretical Model (Six Stages of Change): pre-contemplation, contemplation, preparation, action, maintenance, or relapse. The enrollment stage of change will be used to develop appropriate goals for each participant. Beyond the primary enrolled participant in the study, members of the household will be invited to attend meetings with the RD and Dining with Diabetes program sessions.

Aim 1: Use social network analysis to describe (a) community assets (e.g., access to healthy eating and ways to participate in physical activity) and (b) intergenerational links to obesity and diabetes (e.g., parent, sibling, child).

Social network analysis will be used to map food sources and food assistance (e.g., supermarket, convenience store, fast food, food pantries), including the types of food offered and frequency of engagement with food sources. Similar methods will be used to identify areas/places within the community that could be used to engage in physical activities (e.g., gym, community center, green space, walking trails). A network map will be developed per household to be used to develop a tailored program that that is feasible and accessible to overweight/obese individuals living with diabetes and members of their household.

Participants will be asked to provide the following information on up to 5 immediate family members: age; sex; education level; relationship (e.g., spouse, child, sibling, parent); whether that individual is overweight/obese; and current T2DM diagnosis status (e.g., no diagnosis, diagnosed by a healthcare provider, told by a healthcare provider to be prediabetic). Additional information will be gathered regarding the interconnectedness (e.g., person 1 and person 3 are siblings) of the known relationships between family members.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •must be diagnosed with type 2 diabetes
  • •must be from rural Kentucky
  • •must be living in rural Kentucky for at least 1 year

排除标准

  • •potential participants without consent

研究组 & 干预措施

Medical Nutrition Therapy

Other

Medical Nutrition therapy is an intervention that will be administered to the participants for 6 months.

干预措施: Medical Nutrition Therapy (Behavioral)

结局指标

主要结局

hemoglobin A1c values measured at the five post-baseline follow-up points

时间窗: baseline, 3 months, 6 months, 9 months and 12 months

This is a test that measures average blood sugar levels over the past 3 months

body weight measured at the five post-baseline follow-up points

时间窗: baseline, 3 months, 6 months, 9 months and 12 months

This is an indices used in the estimation of BMI

次要结局

  • Diabetes Knowledge(baseline, 3 months, 6 months, 9 months and 12 months)
  • Diabetes self-management(baseline, 3 months, 6 months, 9 months and 12 months)
  • Dietary Intake(baseline, 3 months, 6 months, 9 months and 12 months)
  • Diabetes Distress(baseline, 3 months, 6 months, 9 months and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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