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

Not Applicable

Not yet recruiting

• Conditions: Prediabetic State; Life Style; Intervention Study; Social Support; Physical Activity; Obesity

• Registration Number: NCT06690788
• Lead Sponsor: University of Utah

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 l...

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-...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-08-12
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-15
• Last Update Posted: 2024-11-15
• Study Start: 2024-12
• Primary Completion: 2028-08
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 324

Inclusion Criteria

1. "Target partner" is eligible for the National DPP per CDC eligibility requirements below.

   A. BMI >= 25 kg/m2 (>= 23kg/m2 if Asian American), and

   B. High risk for type 2 diabetes, based on one or more of the below:

   i. CDC Prediabetes Risk Test score >= 5 ii. A blood test result indicative of prediabetes in the past year:

   1. Fasting blood glucose 100-125 mg/dl,
   2. Plasma glucose of 140-199 mg/dl measured 2 hours after a 75 g glucose load, or
   3. HbA1c of 5.7%-6.4%

   iii. Clinically diagnosed Gestational Diabetes during a previous pregnancy (for women)

   C. Do not have a diagnosis of type 1 or type 2 diabetes.

   D. Not currently pregnant.

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.

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Exclusion Criteria

1. "Target partner" (i.e., individual eligible for National DPP):

   A. Have a diagnosis of another chronic disease (unless no major events/changes for 3+ months),

   B. Are currently on medication or engaged in lifestyle intervention for prediabetes or obesity, or

   C. Have previously participated in the National DPP.

2. Either partner:

A. Reports they are uncomfortable participating in an intervention together with their partner

B. A low level of relationship commitment (i.e., a rating of 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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent of target partners achieving clinically meaningful increases in Moderate to Vigorous Physical Activity (MVPA)	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 o...

Secondary Outcome Measures

Name	Time	Method
HbA1c	14 months	Assessed by the research team using the A1c Now Point of Care System.
Weight	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.
Stress	14 months	Assessed with the Perceived Stress Scale measure (Possible score range: 0-24, with higher scores representing higher levels of perceived stress).
Nutrition	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 KCal. (HEI Score Range: 0-100, with higher scores representing sets of foods that more closely align with key dietary recommendations ...
Sleep	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 leve...
Perceived Partner Support	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 part...

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States