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临床试验/NCT06690788
NCT06690788招募中不适用

PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes

University of Utah1 个研究点 分布在 1 个国家目标入组 324 人开始时间: 2025年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
324
试验地点
1
主要终点
Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA)

研究概览

简要总结

Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. The overall goal of this community-engaged research is to examine the efficacy of an innovative couple-based lifestyle intervention to prevent type 2 diabetes that is applicable to a broad range of partnered adults in the United States. By simultaneously targeting lifestyle and perceived support from romantic partners, there is a high likelihood of creating lasting changes in both

详细描述

Nearly half of U.S. adults have or are at risk of developing type 2 diabetes. Lifestyle intervention is efficacious and the first line of prevention among adults at high risk for type 2 diabetes. Unfortunately, outcomes in real-world settings do not approach the initial efficacy trial findings, in part due to low rates of retention in the intervention. Real-world programs have particularly struggled to retain participants who identify as members of racial/ethnic groups that are disproportionately affected by type 2 diabetes, potentially exacerbating health disparities. Given the strong influence romantic partners have on one another and the shared environment, in which couples typically live, lifestyle interventions that systematically include romantic partners have the potential to address the research-practice gap. The purpose of this project is to examine the efficacy of PreventT2 Together, a couple-based lifestyle intervention our team developed. The specific aims of the research are: (1) to determine the efficacy of PreventT2 Together in a single-center, randomized clinical trial,(2) to examine baseline relationship satisfaction as a moderator and perceived partner support as a mechanism of lifestyle change, and (3) to quantify intervention retention and describe reach across recruitment methods. The investigators will recruit 162 couples (i.e., adults at high risk for type 2 diabetes and their romantic partners)from community and healthcare settings, over-sampling members of racial/ethnic minority groups. The investigators will randomize participating couples to individual (PreventT2; delivered only to partners at high risk) or couple-based (PreventT2 Together; delivered to couples) lifestyle intervention conditions. HbA1c and objectively measured moderate to vigorous physical activity (MVPA) will be collected from all participants at baseline (Pre)and at the end of the 1-year intervention (Post). Participants will also report on lifestyle factors, health outcomes, and relationship functioning at each of 13-time points (Pre, monthly, during the intervention, and post). The investigators focus on the patient-centered minimum clinically important difference (MCID) in outcomes, including objectively-measured MVPA (primary outcome), as well as other aspects of lifestyle (nutrition, sleep), health outcomes (HbA1c, weight loss, stress), and relationship functioning (perceived partner support) (secondary outcomes). Situating lifestyle intervention within the romantic relationship context in which lifestyle change occurs is likely to increase reach and improve retention and lifestyle change outcomes in real-world settings. Our community-engaged approach to the development of the intervention and design of the proposed project will ensure broad applicability and dissemination of results across communities, including racial/ethnic minority groups that have not been effectively reached and retained. CDC review and approval of PreventT2 Together for use as an alternate curriculum in the National Diabetes Prevention Program (National DPP) delivered across the U.S. underscores the scalability of the intervention. If efficacious, PreventT2 Together has the potential to impact individuals and their romantic partners' quality of life and ultimately improve real-world outcomes of lifestyle intervention to prevent type 2 diabetes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
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
是

入选标准

  • •"Target partner" is eligible for the National DPP per CDC eligibility requirements:
  • •BMI ≥ 25 kg/m² (≥ 23 kg/m² if Asian American), and
  • •Do not have a diagnosis of type 1 or type 2 diabetes, and
  • •Not currently pregnant, and
  • •High risk for type 2 diabetes based on: (i) CDC Prediabetes Risk Test score ≥ 5, (ii) clinically diagnosed Gestational Diabetes during a previous pregnancy (for women), or (iii) a blood test result indicative of prediabetes in the past year (i.e., fasting blood glucose 100-125 mg/dl; plasma glucose 140-199 mg/dl measured 2 hours after a 75 g glucose load; or HbA1c 5.7%-6.4%).
  • •The couple has lived together for 1+ years.
  • •Both partners are willing to participate in the research.
  • •Both partners are at least 18 years old.
  • •Both partners are fluent in English.

排除标准

  • •"Supporting partner" has a diagnosis of Type 2 Diabetes.
  • •Either partner:
  • •Has a diagnosis of another chronic disease (unless no major events/changes for 3+ months), or
  • •Is currently on medication or engaged in lifestyle intervention for prediabetes or obesity, or
  • •Has previously participated in the National DPP, or
  • •Reports discomfort participating in a lifestyle program with their partner, or
  • •Reports a low level of relationship commitment (i.e., "4" or lower on a scale from 1 (do not agree at all) to 7 (agree completely) on the item "I want this relationship to stay strong no matter what rough times we encounter."; Owen et al., 2011).

研究组 & 干预措施

Individual intervention condition

Active Comparator

"PreventT2" individual lifestyle intervention curriculum (2021 revised National DPP curriculum, freely available from the CDC)

干预措施: Individual intervention condition (PreventT2) (Behavioral)

Couple-based intervention condition

Experimental

"PreventT2 Together" (couple-based adaptation of PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the National DPP)

干预措施: Couple-based intervention condition (PreventT2 Together; couple-based adaptation of 2021 PreventT2; approved by the CDC in November 2022 as an Alternate Curriculum for use in the NDPP) (Behavioral)

结局指标

主要结局

Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA)

时间窗: 14 months

International Physical Activity Questionnaire (IPAQ)-7 day (Pre-Intervention, Post-Intervention) and a 7-day At-Home accelerometer assessment (Pre-Intervention, Post-Intervention). International Physical Activity Questionnaire (IPAQ)-7 day (Monthly during Intervention). Among participants attending intervention classes, starting at the fourth class minutes of moderate-to-vigorous physical activity (MVPA) over the past week will be reported to Lifestyle Coaches. International Physical Activity Questionnaire (IPAQ) questionnaires assess self-reported walking, moderate intensity, and vigorous intensity physical activity as well as overall sedentary time. Accelerometers provide objective assessments of these constructs. Intervention class participants self-report the total number of Moderate to Vigorous Physical Activity (MVPA) minutes over the previous week.

次要结局

  • Sleep(14 months)
  • Perceived Partner Support(14 months)
  • HbA1c(14 months)
  • Weight(14 months)
  • Stress(14 months)
  • Nutrition(14 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Katherine Baucom

Assistant Professor

University of Utah

研究点 (1)

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