Couple-based lifestyle intervention to prevent type 2 diabetes: protocol for a randomised pilot trial

Madelyn Whitaker, Monique C. Aguirre, Manuel Gutierrez Chavez, Elizabeth Beaulieu, Yeny B. Arones, Dana Gershenoff, Kristie Hinton, Natalie Klein, Jeanne Munezerou Uwizeye, Eru Napia, Carmen Ramos, O. Fahina Tavake-Pasi, Jeannette Villalta, Cathy Wolfsfeld, Brieanne Witte, Ellen Maxfield, Kalani Raphael, Debra L. Simmons, Lauren Clark, Tamara SherTimothy W. Smith, Katherine J.W. Baucom

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Introduction Type 2 diabetes is prevalent among US adults. Lifestyle interventions that modify health behaviours prevent or delay progression to diabetes among individuals at high risk. Despite the well-documented influence of individuals' social context on their health, evidence-based type 2 diabetes prevention interventions do not systematically incorporate participants' romantic partners. Involving partners of individuals at high risk for type 2 diabetes in primary prevention may improve engagement and outcomes of programmes. The randomised pilot trial protocol described in this manuscript will evaluate a couple-based lifestyle intervention to prevent type 2 diabetes. The objective of the trial is to describe the feasibility of the couple-based intervention and the study protocol to guide planning of a definitive randomised clinical trial (RCT). Methods and analysis We used community-based participatory research principles to adapt an individual diabetes prevention curriculum for delivery to couples. This parallel two-arm pilot study will include 12 romantic couples in which at least one partner (ie, 'target individual') is at risk for type 2 diabetes. Couples will be randomised to either the 2021 version of the CDC's PreventT2 curriculum designed for delivery to individuals (six couples), or PreventT2 Together, the adapted couple-based curriculum (six couples). Participants and interventionists will be unblinded, but research nurses collecting data will be blinded to treatment allocation. Feasibility of the couple-based intervention and the study protocol will be assessed using both quantitative and qualitative measures. Ethics and dissemination This study has been approved by the University of Utah IRB (#143079). Findings will be shared with researchers through publications and presentations. We will collaborate with community partners to determine the optimal strategy for communicating findings to community members. Results will inform a subsequent definitive RCT.

Original languageEnglish (US)
Article numbere068623
JournalBMJ open
Issue number2
StatePublished - Feb 16 2023
Externally publishedYes



ASJC Scopus subject areas

  • General Medicine


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