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

• Published in: BMJ open Vol. 13; no. 2; p. e068623
• Main 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
• Format: Journal Article
• Language: English
• Published: England British Medical Journal Publishing Group 16.02.2023; BMJ Publishing Group LTD; BMJ Publishing Group
• Series: Protocol
• Subjects: Adaptation; Adult; Collaboration; Community; Couples; Curricula; Diabetes; DIABETES & ENDOCRINOLOGY; Diabetes and Endocrinology; Diabetes Mellitus, Type 2 - prevention & control; Disease control; Disease prevention; Empowerment; Health behavior; Hispanic people; Humans; Intervention; Life Style; Lifestyles; Nutrition; NUTRITION & DIETETICS; Participatory research; Pilot Projects; Prevention programs; PREVENTIVE MEDICINE; PUBLIC HEALTH; Randomized Controlled Trials as Topic; Retention; United States > US; PUBLIC HEALTH; PREVENTIVE MEDICINE; NUTRITION & DIETETICS; DIABETES & ENDOCRINOLOGY
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2022-068623

IntroductionType 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 analysisWe 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 disseminationThis 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 numberNCT05695170