Clinical trial NCT06690788: PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
Official title: PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prediabetic State
Life Style
Intervention Study
Social Support
Physical Activity
Obesity
Keywords: Lifestyle Intervention
Prevention
Social Support
Couple Relationships
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-11-15
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. "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%).
2. The couple has lived together for 1+ years.
3. Both partners are willing to participate in the research.
4. Both partners are at least 18 years old.
5. Both partners are fluent in English.

EXCLUSION CRITERIA:

1. "Supporting partner" has a diagnosis of Type 2 Diabetes.
2. 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).

Primary outcomes:
measure: Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA)
timeFrame: 14 months
Secondary outcomes:
measure: HbA1c
timeFrame: 14 months
measure: Weight
timeFrame: 14 months
measure: Stress
timeFrame: 14 months
measure: Nutrition
timeFrame: 14 months
measure: Sleep
timeFrame: 14 months
measure: Perceived Partner Support
timeFrame: 14 months
Other outcomes:
measure: Anxiety
timeFrame: 14 months
measure: Depression
timeFrame: 14 months
measure: Fatigue
timeFrame: 14 months
measure: Relationship Satisfaction
timeFrame: 14 months
measure: Interest in Sexual Activity
timeFrame: 14 months
measure: Intervention Attendance
timeFrame: 12 months
measure: Lifestyle Coach Fidelity
timeFrame: 12 months
measure: Additional lifestyle intervention engagement
timeFrame: 12 months
measure: Intervention Retention
timeFrame: 12 months
measure: Percent of individuals approached who are eligible and enroll in the study (Reach)
timeFrame: 14 months
measure: Intervention Acceptability
timeFrame: 14 months
measure: Pain Interference
timeFrame: 14 months
measure: Daily Report of Social Control
timeFrame: 14 months
measure: Communal Coping
timeFrame: 14 months
measure: The Accountable Health Communities Screening Tool
timeFrame: 14 months
measure: Health Care Access and Preventive Health Screenings
timeFrame: 14 months
measure: Percent of supporting partners who enroll in the study that are at high risk for type 2 diabetes based on the Pre HbA1c and self-report questionnaires (Reach)
timeFrame: 14 months
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Katherine JW Baucom, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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. doi: 10.1136/bmjopen-2022-068623.