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

Обзор

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

Подробное описание

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.

Вмешательства

• Поведенческое Individual intervention condition (PreventT2)
  PreventT2 will be delivered by a team of trained CDC National Diabetes Prevention Program (NDPP) Lifestyle Coaches to adults at high risk for diabetes. The 2021 version of the lifestyle intervention curriculum to be used is freely available from the CDC. The intervention will be delivered in the context of the University of Utah National DPP, which has Full recognition from the CDC based on outcome data over the course of a number of years.
• Поведенческое 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)
  PreventT2 Together will be delivered by a team of trained CDC National DPP Lifestyle Coaches to adults at high risk for diabetes and their partners. The lifestyle intervention curriculum was developed with the input of a community advisory board and was approved by the CDC for use in the National DPP (Diabetes Prevention Program) (i.e., meets CDC Diabetes Prevention Recognition Program Standards, including 22+ classes delivered over the course of 12 months and targeting lifestyle changes to prev

Первичные конечные точки

• Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA) [Срок оценки: 14 months]

Вторичные конечные точки (6)

• HbA1c [Срок оценки: 14 months]
• Weight [Срок оценки: 14 months]
• Stress [Срок оценки: 14 months]
• Nutrition [Срок оценки: 14 months]
• Sleep [Срок оценки: 14 months]
• Perceived Partner Support [Срок оценки: 14 months]

Критерии участия

Критерии включения

• "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.

Критерии исключения

• "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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Utah — Salt Lake City

Публикации

• Aguirre MC, Brown H, Gershenoff D, Hinton KL, Huntzinger OM, Klein N, Ramos C, Tavake-Pasi OF, Witte B, Wolfsfeld M, Sher T, Simmons DL, Smith TW, Clark L, Baucom KJW. The Role of Advocacy in Adapting the Diabetes Prevention Program for Couple-Based Delivery That Reaches Marginalized Groups. Behav Ther (N Y N Y). 2020 Oct;43(7):261-265. No abstract available. PMID 33536698
• Whitaker M, Aguirre MC, Gutierrez Chavez M, Beaulieu E, Arones YB, Gershenoff D, Hinton K, Klein N, Munezerou Uwizeye J, Napia E, Ramos C, Tavake-Pasi OF, Villalta J, Wolfsfeld C, Witte B, Maxfield E, Raphael K, Simmons DL, Clark L, Sher T, Smith TW, Baucom KJ. Couple-based lifestyle intervention to prevent type 2 diabetes: protocol for a randomised pilot trial. BMJ Open. 2023 Feb 16;13(2):e068623 PMID 36797025

Идентификаторы

NCT: NCT06690788 · 166946 · 1R01DK140177-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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