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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02617693
Recruitment Status : Completed
First Posted : December 1, 2015
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Behavioral: lifestyle intervention Other: standard antenatal care Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 552 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
Actual Study Start Date : November 23, 2015
Actual Primary Completion Date : December 9, 2017
Actual Study Completion Date : December 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Difference in waist circumference [ Time Frame: Months 0-8 ]

Secondary Outcome Measures :
  1. Change in BMI (Body Mass Index) [ Time Frame: Month 0, Month 8 ]
  2. Change in waist-to-height ratio (WHtR) [ Time Frame: Month 0, Month 8 ]
  3. Change in waist-to-hip ratio [ Time Frame: Month 0, Month 8 ]
  4. Change in weight [ Time Frame: Month 0, Month 8 ]
  5. Change in HbA1c (Glycosylated haemoglobin)) [ Time Frame: Month 0, Month 8 ]
  6. 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 ]
  7. Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure)) [ Time Frame: Month 0, Month 8 ]
  8. 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 ]
  9. 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 ]
  10. Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ) [ Time Frame: Month 0, Month 8 ]
  11. 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 ]
  12. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02617693


Locations
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Malaysia
Novo Nordisk Investigational Site
Seremban, Negeri Sembilan, Malaysia, 70400
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02617693    
Other Study ID Numbers: INS-4186
U1111-1160-2987 ( Other Identifier: WHO )
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases