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

Diabetes Mellitus, Type 2 Clinical Trial

— Jom Mama  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02617693
• Other study ID #: INS-4186
• Secondary ID: U1111-1160-2987
• Status: Completed
• Phase: Phase 4
• Start date: November 23, 2015
• Est. completion date: December 9, 2017

Study information

• Verified date: February 2019
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: December 9, 2017
• Est. primary completion date: December 9, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Prediabetic State

Intervention

Behavioral:
• lifestyle 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.

Other:
• standard antenatal care
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.

Locations

Country	Name	City	State
Malaysia	Novo Nordisk Investigational Site	Seremban, Negeri Sembilan

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in waist circumference		Months 0-8
Secondary	Change in BMI (Body Mass Index)		Month 0, Month 8
Secondary	Change in waist-to-height ratio (WHtR)		Month 0, Month 8
Secondary	Change in waist-to-hip ratio		Month 0, Month 8
Secondary	Change in weight		Month 0, Month 8
Secondary	Change in HbA1c (Glycosylated haemoglobin))		Month 0, Month 8
Secondary	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
Secondary	Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))		Month 0, Month 8
Secondary	Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)		Month 0, Month 8
Secondary	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
Secondary	Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)		Month 0, Month 8
Secondary	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
Secondary	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

External Links

•   Clinical Trials at Novo Nordisk