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Completed

NCT Number: NCT02617693

Development of 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site

Seremban, Negeri Sembilan, 70400, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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.

standard antenatal care

Other

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 outcomes

  1. Difference in waist circumference

    Time frame: Months 0-8

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: Jom Mama

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 1, 2015
Registry last updated
Feb 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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