TY - JOUR
T1 - Couple-based lifestyle intervention to prevent type 2 diabetes
T2 - protocol for a randomised pilot trial
AU - Whitaker, Madelyn
AU - Aguirre, Monique C.
AU - Gutierrez Chavez, Manuel
AU - Beaulieu, Elizabeth
AU - Arones, Yeny B.
AU - Gershenoff, Dana
AU - Hinton, Kristie
AU - Klein, Natalie
AU - Munezerou Uwizeye, Jeanne
AU - Napia, Eru
AU - Ramos, Carmen
AU - Tavake-Pasi, O. Fahina
AU - Villalta, Jeannette
AU - Wolfsfeld, Cathy
AU - Witte, Brieanne
AU - Maxfield, Ellen
AU - Raphael, Kalani
AU - Simmons, Debra L.
AU - Clark, Lauren
AU - Sher, Tamara
AU - Smith, Timothy W.
AU - Baucom, Katherine J.W.
N1 - Funding Information:
Prior to submission of a proposal for extramural funding, in January 2017, the research team collaborated with the University of Utah Clinical and Translational Science Institute (CTSI) Community Collaboration and Engagement Team to conduct a one-time focus group meeting. Participants (n=8) in the focus group included individuals with relevant personal and/or professional expertise from five community organisations within the Salt Lake Valley: Best of Africa, Calvary Baptist Church, the Hispanic Health Care Task Force, the National Tongan American Society of Utah and the Urban Indian Center of Salt Lake. The grant proposal, which integrated feedback from this focus group on the overall research question and planned methods, was funded by the National Institute of Diabetes and Digestive and Kidney Diseases in June 2018.
Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by the National Institutes of Health (grant numbers 5K23 DK115820-05, 3K23 DK115820-05S1 (PI: KB) and UL1TR002538).
Publisher Copyright:
© 2023 BMJ Publishing Group. All rights reserved.
PY - 2023/2/16
Y1 - 2023/2/16
N2 - 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.
AB - 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.
KW - DIABETES & ENDOCRINOLOGY
KW - NUTRITION & DIETETICS
KW - PREVENTIVE MEDICINE
KW - PUBLIC HEALTH
UR - http://www.scopus.com/inward/record.url?scp=85148256259&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85148256259&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2022-068623
DO - 10.1136/bmjopen-2022-068623
M3 - Article
C2 - 36797025
AN - SCOPUS:85148256259
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 2
M1 - e068623
ER -