Jutta Skau|Awatef Binti Amer Nordin|Julius Cheah|Roslinah Ali|Ramli Zainal|Tahir Aris|Zainudin Mohd Ali|P Matzen|Regien Biesma|Jens Aagaard?Hansen|Mark Hanson|Shane A. Norris
A complex behavioural change intervention to reduce the risk of diabetes and prediabetes in the pre-conception period in Malaysia: study protocol for a randomised controlled trial
University of the Witwatersrand|Ministry of Health|Monash University Malaysia|Ministry of Health|Ministry of Health|Ministry of Health|Malaysia Theological Seminary|Ministry of Health|University of Southampton|University of Southampton|Steno Diabetes Center|University of Southampton|University of the Witwatersrand
past two decades population malaysia grown rapidly prevalence diabetes mellitus malaysia dramatically increased along frequency obesity hyperlipidaemia hypertension earlylife influences play important role development noncommunicable diseases indeed maternal lifestyle conditions gestational diabetes mellitus obesity affect risk diabetes next generation lifestyle changes help prevent development type 2 diabetes mellitus protocol unblinded communitybased randomised controlled trial two arms evaluate efficacy complex behavioural change intervention combining motivational interviewing provided community health promoter access habit formation mobile application among young malaysian women spouses prior pregnancyeligible subjects malaysian women age group 20 39 years nulliparous diagnosed diabetes smartphone alphavalue 005 statistical power 90 264 subjects need complete study subjects spouses randomised either intervention control arm 8month period primary endpoint change waist circumference baseline end intervention period secondary endpoints changes anthropometric parameters biochemical parameters change health literacy level dietary habits physical activity stress level primary endpoint continuous secondary endpoints analysed linear regression model whereas secondary endpoints ordinal scale analysed using chisquared test multivariate linear model primary endpoint undertaken account potential confounders study approved medical research ethics committee ministry health malaysia protocol number nmrr1490421963 21 september 2015this study protocol describes first communitybased randomised controlled trial examine efficacy complex intervention improving prepregnancy health young malaysian women spouses results trial contribute improve policy practices regarding complex behavioural change interventions prevent diabetes preconception period malaysia low middleincome country settingsthis trial registered clinicaltrialsgov wwwclinicaltrialsgov 30 november 2015 identifier nct02617693