Clinical trial NCT02617693: Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
Official title: Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-12-01
Enrollment: 552
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is conducted in Asia. The aim of this study is to assess the efficacy of a pre-pregnancy life style intervention to reduce the risk of diabetes and prediabetes.


Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Nulliparity
* Not pregnant at the time of signing informed consent
* Own a smartphone with either Android system version 4.1 and above or iOS system 7.0 and above with internet access

Exclusion Criteria:

* Female subject undergoing treatment for type 1 or 2 diabetes mellitus
* Subjects not residing in the district of Seremban

Primary outcomes:
measure: Difference in waist circumference
timeFrame: Months 0-8
Secondary outcomes:
measure: Change in BMI (Body Mass Index)
timeFrame: Month 0, Month 8
measure: Change in waist-to-height ratio (WHtR)
timeFrame: Month 0, Month 8
measure: Change in waist-to-hip ratio
timeFrame: Month 0, Month 8
measure: Change in weight
timeFrame: Month 0, Month 8
measure: Change in HbA1c (Glycosylated haemoglobin))
timeFrame: Month 0, Month 8
measure: Change in the fasting lipid profile (total cholesterol [TC], low density lipoprotein cholesterol[LDL-C], high density lipoprotein cholesterol[HDL-C], triglycerides [TG])
timeFrame: Month 0, Month 8
measure: Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))
timeFrame: Month 0, Month 8
measure: Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)
timeFrame: Month 0, Month 8
measure: Change in dietary intake, as measured by the Frequency Food Questionnaire (FFQ) that is used in National Health Surveys in Malaysia
timeFrame: Month 0, Month 8
measure: Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)
timeFrame: Month 0, Month 8
measure: Change in physical activity and sedentary behaviour, as measured by the International Physical Activity Questionnaire (IPAQ) used in National Health Surveys in Malaysia
timeFrame: Month 0, Month 8
measure: Change in stress levels, as measured by the Depression Anxiety and Stress Scale 21-items (DASS-21) used in National Health Surveys in Malaysia
timeFrame: Month 0, Month 8
Other outcomes:
Locations:
city: Seremban, Negeri Sembilan
country: Malaysia
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Skau JK, Nordin AB, Cheah JC, Ali R, Zainal R, Aris T, Ali ZM, Matzen P, Biesma R, Aagaard-Hansen J, Hanson MA, Norris SA. 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. Trials. 2016 Apr 27;17(1):215. doi: 10.1186/s13063-016-1345-x.