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NCT Number: NCT06690788

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

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

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Key information

Conditions

Prediabetic State Behavior Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Intervention Study Life Style Metabolic Diseases Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Physical Activity Signs and Symptoms Social Support

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

Location status: Recruiting

Location contact

Elizabeth Z Beaulieu, BS

CONTACT

[email protected]

801-696-3757

Katherine JW Baucom, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • "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.

Exclusion criteria

  • "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).

Treatment and study plan

Individual intervention condition (PreventT2)

Behavioral

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.

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

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 prevent type 2 diabetes). In contrast to PreventT2, the intervention includes content specific to couples with prompts encouraging partners to consider and discuss how they can best support one another, information about lifestyle intervention in a relationship context, and examples demonstrating how couples collaborated to make healthy lifestyle changes.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. HbA1c

    Time frame: 14 months

    Assessed by the research team using the A1c Now Point of Care System.

  2. Weight

    Time frame: 14 months

    Weight in pounds will be assessed by the research team at both the Pre and Post time points using a medical grade scale. Among participants attending intervention classes, weight in pounds will be privately measured by Lifestyle Coaches before each class.

  3. Stress

    Time frame: 14 months

    Assessed with the Perceived Stress Scale measure (Possible score range: 0-24, with higher scores representing higher levels of perceived stress).

  4. Nutrition

    Time frame: 14 months

    Assessed with the Automated self-administered 24-hr recall (ASA24) (Pre, Post). We will examine the following outcomes: Healthy Eating Index (HEI), total vegetable, added sugars, fiber, whole grains, refined grains, and total KiloCalorie. (HEI Score Range: 0-100, with higher scores representing sets of foods that more closely align with key dietary recommendations and patterns.)(Total Vegetable expressed in cups, added sugars expressed in teaspoon equivalents, fiber expressed in grams, whole grains expressed in ounce equivalents, refined grains expressed in ounce equivalents, and total KCal expressed in kilocalories.)

    Assessed with the Rapid Eating and Activity Assessment for Participants (REAP-S; Composite Score Range 13-39, with higher scores representing higher diet quality) (Monthly).

  5. Sleep

    Time frame: 14 months

    Assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Version 1.0 Sleep-Related Impairment 8a (T-score range: 30-80.1, with higher scores indicating higher levels of sleep-related impairment) and the PROMIS Short Form Version 1.0 Sleep Disturbance 8a (T-score range: 30.5-77.5, with higher scores indicating higher levels of sleep disturbance).

  6. Perceived Partner Support

    Time frame: 14 months

    Assessed with the Multidimensional Scale of Perceived Social Support "special person" subscale, with the language updated to "romantic partners," consistent with prior work. This subscale assesses the amount of support individuals perceive from their romantic partners (Score range: 4-28, with higher scores indicating more perceived support from romantic partners).

Other outcomes

  1. Anxiety

    Time frame: 14 months

    Assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Version 1.0 Anxiety 8a (T-score range: 37.1-83.1, with higher scores indicating higher levels of anxiety symptoms).

  2. Depression

    Time frame: 14 months

    Assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Version 1.0 Depression 8a (T-score range: 38.2-81.3, with higher scores indicating higher levels of depressive symptoms).

  3. Fatigue

    Time frame: 14 months

    Assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Fatigue 7a (T-score range: 29.4-83.2, with higher scores indicating higher levels of fatigue).

  4. Relationship Satisfaction

    Time frame: 14 months

    Assessed with the Couples Satisfaction Index-16 (CSI-16), a measure of overall relationship satisfaction (Score range: 0-81, with higher scores indicating higher levels of relationship satisfaction).

  5. Interest in Sexual Activity

    Time frame: 14 months

    Assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale Version 2.0 Sexual Function and Satisfaction: Interest in Sexual Activity (T-score range: 21.9-65.8, with higher scores indicating more interest in sexual activity).

  6. Intervention Attendance

    Time frame: 12 months

    Lifestyle Coaches will record whether participants attend each intervention class. Total intervention attendance will be the total number of classes attended in-person (make-up classes, while offered to participants who miss the in-person class, will not count toward this total).

  7. Lifestyle Coach Fidelity

    Time frame: 12 months

    A DTTAC Master Trainer Select will rate Lifestyle Coach fidelity in 10% of classes.

  8. Additional lifestyle intervention engagement

    Time frame: 12 months

    Participants will respond to a single item on the questionnaire regarding whether they received additional lifestyle intervention to supplement National DPP classes. If yes, they will be asked to describe what they did as well as the frequency and duration of the intervention.

  9. Intervention Retention

    Time frame: 12 months

    Intervention Retention will be measured by whether participants meet CDC criteria for "completer" status (i.e., attend at least 9 total classes, with at least 8 classes in the first six months of the program, and at least 1 class in the second six months of the program that occurs 9 months following the first class).

  10. Percent of individuals approached who are eligible and enroll in the study (Reach)

    Time frame: 14 months

    Reach will be measured by (a) the percent of individuals approached who are eligible and enroll in the study.

  11. Intervention Acceptability

    Time frame: 14 months

    Acceptability of the individual and couple-based lifestyle interventions will be measured with the Theoretical Framework of Acceptability-Based Questionnaire

  12. Pain Interference

    Time frame: 14 months

    Assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form Version 1.0 4a (T-score range: 41.6 - 75.6 with a higher score indicating more pain interference.)

  13. Daily Report of Social Control

    Time frame: 14 months

    Assessed with the Daily Report of Social Control Measure (Score Range 1-2 with lower scores indicating more Social support from partners.)

  14. Communal Coping

    Time frame: 14 months

    Assessed with the Theoretical Model of Communal Coping (TMCC) Appraisal and Action Subscales. (Score Range of 33-50, with higher scores indicating more shared appraisal or action.)

  15. The Accountable Health Communities Screening Tool

    Time frame: 14 months

    Assessed with the Accountable Health Communities Core Health-Related Social Needs Screening Questions. (No score range, but underlined answer options indicate positive responses for the associated health-related social need.)

  16. Health Care Access and Preventive Health Screenings

    Time frame: 14 months

    Assessed with questions from the National Health Interview Survey (NHIS.) (No Score Range, but questions indicate health care access, occurrence of preventive health screenings, as well as delay or missing health care intervention due to cost avoidance.)

  17. 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)

    Time frame: 14 months

    Reach will be measures by the 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

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Z Beaulieu, B.S.

CONTACT

[email protected]

801-696-3757

Katherine JW Baucom, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: PT2T

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Nov 15, 2024
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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