BMJ Open (Feb 2023)

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

  • Lauren Clark,
  • Timothy W Smith,
  • Debra L Simmons,
  • 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,
  • Tamara Sher,
  • Katherine JW Baucom

DOI
https://doi.org/10.1136/bmjopen-2022-068623
Journal volume & issue
Vol. 13, no. 2

Abstract

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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.Trial registration number NCT05695170