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 - 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
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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 -