Couple-based lifestyle intervention to prevent type 2 diabetes: protocol for a randomised pilot trial.
Madelyn Whitaker, Monique C Aguirre, Manuel Gutierrez Chavez...
https://pubmed.ncbi.nlm.nih.gov/36797025/Actively Recruiting
Led by University of Utah · Updated on 2025-05-30
324
Participants Needed
1
Research Sites
N/A
Total Duration
Nearly half of adults in the United States have or are at risk of developing type 2 diabetes. This research aims to evaluate the effectiveness of a new couple-based lifestyle intervention called PreventT2 Together, designed to prevent type 2 diabetes among partnered adults. The study addresses challenges in retaining participants in lifestyle programs, especially among racial and ethnic minority groups, by involving romantic partners to support lasting positive lifestyle changes. Participants will be randomly assigned to one of two groups an individual lifestyle intervention based on the 2021 National Diabetes Prevention Program PreventT2, or a couple-based adaptation of this program PreventT2 Together approved by the CDC. Both interventions are delivered by trained lifestyle coaches over the course of 12 months, with content tailored to either individuals at high risk or couples working together to support healthy lifestyle changes. During the study, 162 couples will be monitored for changes in physical activity levels, specifically moderate to vigorous physical activity, as well as other health and lifestyle factors such as HbA1c, weight, stress, nutrition, sleep, and perceived partner support. Data will be collected at baseline, monthly during the intervention, and at the end of the 1-year period, totaling 13 assessment points. The study will also evaluate relationship satisfaction and intervention retention, with the goal of improving real-world outcomes and reducing health disparities related to type 2 diabetes prevention.
CONDITIONS
PreventT2 Together: Examining the Efficacy of Couple-based Lifestyle Intervention to Prevent Type 2 Diabetes
E
Elizabeth Z Beaulieu, B.S.
K
Katherine JW Baucom, PhD
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University of Utah
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Couple‑based PreventT2 Together (investigational arm) | Individual PreventT2 (current trial arm) | CDC-recognized National DPP (current standard practice) |
|---|---|---|---|
| What it is | A couple‑based adaptation called PreventT2 Together that includes both the at‑risk partner and their romantic partner in the curriculum. | An individual‑focused CDC PreventT2 lifestyle intervention delivered to the partner at high risk. | CDC‑recognized individual National Diabetes Prevention Program lifestyle intervention delivered singly. |
| Role in trial | Investigational arm testing a couple‑based curriculum for diabetes prevention. | Active comparator arm following standard individual curriculum. | Represents established standard practice outside the trial. |
| Primary purpose | Same goal delivered in a couple context to assess whether partner involvement enhances outcomes. | Lifestyle change program for an individual at high risk to reduce type 2 diabetes risk. | Lifestyle intervention for individuals at high risk, as implemented in usual community CDC‑recognized programs. |
| How delivered | Delivered by trained coaches to both partners using couple‑specific prompts and partner‑support content. | Delivered by trained CDC National DPP Lifestyle Coaches to the individual participant. | Typically delivered in community group or individual sessions following CDC curriculum. |
| Evidence status | Effectiveness of couple‑based adaptation is being evaluated; feasibility study underway. | Based on prior NDPP evidence, individual curriculum reduces progression to type 2 diabetes by about 58% over 3 years. | NDPP effectiveness confirmed in real‑world settings with reduced diabetes incidence. |
| Important limitations | Efficacy and feasibility are still under study; impact on long‑term behavior change unknown. | Individual programs may face low retention in real‑world settings, especially among underrepresented groups. | While NDPP is effective, reach remains insufficient and weight‑loss outcomes vary across populations. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants engage in a lifestyle intervention program designed to prevent type 2 diabetes, delivered either individually or with their romantic partner over the course of one year. This program includes 22 or more classes focusing on lifestyle changes such as physical activity, nutrition, sleep, and stress management.
Monthly visits during the intervention
Duration - Approximately 2 months
Participants report lifestyle factors, health outcomes, and relationship functioning to assess the long-term impact of the intervention after the 12-month treatment period.
1 post-intervention visit to assess outcomes at 14 months
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Madelyn Whitaker, Monique C Aguirre, Manuel Gutierrez Chavez...
https://pubmed.ncbi.nlm.nih.gov/36797025/Monique C Aguirre, Heather Brown, Dana Gershenoff...
https://pubmed.ncbi.nlm.nih.gov/33536698/University of Utah
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor