Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes

Study Overview
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Brief Summary
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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.

Official Title
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Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes

Conditions
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Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Behavioral: lifestyle intervention
* Other: standard antenatal care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard of care<br> | Other: standard antenatal care<br>* 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.<br>|
| Experimental: Life style intervention<br> | Behavioral: lifestyle intervention<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in waist circumference |  | Months 0-8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BMI (Body Mass Index) |  | Month 0, Month 8 | 
| 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 blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure)) |  | 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 |