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

ConditionsPrediabetic State Life Style Intervention Study Social Support Physical Activity Obesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Utah

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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%).

Disqualifiers

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

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

324 Participants

are divided into 2 treatment groups

Group A: Individual intervention conditionActive comparator 1 intervention

Group B: Couple-based intervention conditionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

14 months

Secondary outcomes

HbA1c

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

Time frame

14 months

Weight

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.

Time frame

14 months

Stress

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

Time frame

14 months

Nutrition

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).

Time frame

14 months

Other outcomes

Anxiety

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).

Time frame

14 months

Depression

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).

Time frame

14 months

Fatigue

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).

Time frame

14 months

Relationship Satisfaction

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).

Time frame

14 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Utah

Lead sponsor

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

Collaborator

Source ClinicalTrials.gov

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