Diabetes, Diabetes Mellitus, Type 2
Conditions
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.
Interventions
BEHAVIORALlifestyle intervention
Evaluation of lifestyle intervention combining behavioural change councelling and utilisation of E-health platform. The intervention consists of a combination of behaviour change counselling and support through six contact-points with CHPs (community health promoter) and access to a personalised mobile application.
Standard of care for pre-pregnancy health. Subjects will be reminded of their endpoint measurement visit towards the end of the intervention period through a phone call.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in waist circumference | Months 0-8 |
Secondary
| Measure | Time frame |
|---|---|
| Change in waist-to-height ratio (WHtR) | Month 0, Month 8 |
| Change in waist-to-hip ratio | Month 0, Month 8 |
| Change in weight | Month 0, Month 8 |
| Change in HbA1c (Glycosylated haemoglobin)) | Month 0, Month 8 |
| Change in the fasting lipid profile (total cholesterol [TC], low density lipoprotein cholesterol[LDL-C], high density lipoprotein cholesterol[HDL-C], triglycerides [TG]) | Month 0, Month 8 |
| Change in BMI (Body Mass Index) | Month 0, Month 8 |
| Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q) | Month 0, Month 8 |
| Change in dietary intake, as measured by the Frequency Food Questionnaire (FFQ) that is used in National Health Surveys in Malaysia | Month 0, Month 8 |
| Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ) | Month 0, Month 8 |
| Change in physical activity and sedentary behaviour, as measured by the International Physical Activity Questionnaire (IPAQ) used in National Health Surveys in Malaysia | Month 0, Month 8 |
| Change in stress levels, as measured by the Depression Anxiety and Stress Scale 21-items (DASS-21) used in National Health Surveys in Malaysia | Month 0, Month 8 |
| Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure)) | Month 0, Month 8 |
Countries
Malaysia
Outcome results
None listed