Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes (Jom Mama)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Intervention / Treatment: Other: standard antenatal care; Behavioral: lifestyle intervention

• Study Type: Interventional
• Enrollment (Actual): 552
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Seremban, Negeri Sembilan, Malaysia, 70400
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of care	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.
Experimental: Life style 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• 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.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2015
• Primary Completion (Actual): December 9, 2017
• Study Completion (Actual): December 9, 2017

Study Registration Dates

• First Submitted: November 18, 2015
• First Submitted That Met QC Criteria: November 25, 2015
• First Posted (Estimate): December 1, 2015

Study Record Updates

• Last Update Posted (Actual): February 20, 2019
• Last Update Submitted That Met QC Criteria: February 19, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
• Other Study ID Numbers: INS-4186; U1111-1160-2987 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No