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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Other: standard antenatal care; Behavioral: lifestyle intervention

• Registration Number: NCT02617693
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-18
• Study Start: 2015-11-23
• Study First Submitted QC: 2015-11-25
• Study First Posted: 2015-12-01
• Primary Completion: 2017-12-09
• Study Completion: 2017-12-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-19
• Last Update Posted: 2019-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 552

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

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Exclusion Criteria

• Female subject undergoing treatment for type 1 or 2 diabetes mellitus
• Subjects not residing in the district of Seremban

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of care	standard antenatal care	-
Life style intervention	lifestyle intervention	-

Primary Outcome Measures

Name	Time	Method
Difference in waist circumference	Months 0-8

Secondary Outcome Measures

Name	Time	Method
Change in weight	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 HbA1c (Glycosylated haemoglobin))	Month 0, Month 8
Change in BMI (Body Mass Index)	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
Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)	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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇲🇾 Seremban, Negeri Sembilan, Malaysia