Couple-based lifestyle intervention to prevent type 2 diabetes: protocol for a randomised pilot trial. Issue 2 (16th February 2023)

• Record Type: Journal Article
• Authors: Whitaker, Madelyn; Aguirre, Monique C; Gutierrez Chavez, Manuel; Beaulieu, Elizabeth; Arones, Yeny B; Gershenoff, Dana; Hinton, Kristie; Klein, Natalie; Munezerou Uwizeye, Jeanne; Napia, Eru; Ramos, Carmen; Tavake-Pasi, O Fahina; Villalta, Jeannette; Wolfsfeld, Cathy; Witte, Brieanne; Maxfield, Ellen; Raphael, Kalani; Simmons, Debra L; Clark, Lauren; Sher, Tamara; Smith, Timothy W; Baucom, Katherine JW
• Is Part Of: BMJ open. Volume 13:Issue 2(2023)
• Publication Date: 2023-02-16
• Subjects: PREVENTIVE MEDICINE -- DIABETES & ENDOCRINOLOGY -- NUTRITION & DIETETICS -- PUBLIC HEALTH; Medicine -- Research -- Periodicals; 610.72
• DOI: 10.1136/bmjopen-2022-068623
• Languages: English
• ISSNs: 2044-6055

Abstract

Abstract : 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