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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
Malaysia
Study Type
Interventional
Intervention
lifestyle intervention
standard antenatal care
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Standard of care

Life style intervention

Arm Description

Outcomes

Primary Outcome Measures

Difference in waist circumference

Secondary Outcome Measures

Change in BMI (Body Mass Index)
Change in waist-to-height ratio (WHtR)
Change in waist-to-hip ratio
Change in weight
Change in HbA1c (Glycosylated haemoglobin))
Change in the fasting lipid profile (total cholesterol [TC], low density lipoprotein cholesterol[LDL-C], high density lipoprotein cholesterol[HDL-C], triglycerides [TG])
Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))
Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)
Change in dietary intake, as measured by the Frequency Food Questionnaire (FFQ) that is used in National Health Surveys in Malaysia
Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)
Change in physical activity and sedentary behaviour, as measured by the International Physical Activity Questionnaire (IPAQ) used in National Health Surveys in Malaysia
Change in stress levels, as measured by the Depression Anxiety and Stress Scale 21-items (DASS-21) used in National Health Surveys in Malaysia

Full Information

First Posted
November 18, 2015
Last Updated
February 19, 2019
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT02617693
Brief Title
Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
Acronym
Jom Mama
Official Title
Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
November 23, 2015 (Actual)
Primary Completion Date
December 9, 2017 (Actual)
Study Completion Date
December 9, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
552 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of care
Arm Type
Other
Arm Title
Life style intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
lifestyle intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
standard antenatal care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Difference in waist circumference
Time Frame
Months 0-8
Secondary Outcome Measure Information:
Title
Change in BMI (Body Mass Index)
Time Frame
Month 0, Month 8
Title
Change in waist-to-height ratio (WHtR)
Time Frame
Month 0, Month 8
Title
Change in waist-to-hip ratio
Time Frame
Month 0, Month 8
Title
Change in weight
Time Frame
Month 0, Month 8
Title
Change in HbA1c (Glycosylated haemoglobin))
Time Frame
Month 0, Month 8
Title
Change in the fasting lipid profile (total cholesterol [TC], low density lipoprotein cholesterol[LDL-C], high density lipoprotein cholesterol[HDL-C], triglycerides [TG])
Time Frame
Month 0, Month 8
Title
Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))
Time Frame
Month 0, Month 8
Title
Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)
Time Frame
Month 0, Month 8
Title
Change in dietary intake, as measured by the Frequency Food Questionnaire (FFQ) that is used in National Health Surveys in Malaysia
Time Frame
Month 0, Month 8
Title
Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)
Time Frame
Month 0, Month 8
Title
Change in physical activity and sedentary behaviour, as measured by the International Physical Activity Questionnaire (IPAQ) used in National Health Surveys in Malaysia
Time Frame
Month 0, Month 8
Title
Change in stress levels, as measured by the Depression Anxiety and Stress Scale 21-items (DASS-21) used in National Health Surveys in Malaysia
Time Frame
Month 0, Month 8

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Seremban, Negeri Sembilan
ZIP/Postal Code
70400
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk.com
Citations:
PubMed Identifier
27117703
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.
Results Reference
derived
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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