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

NCT02617693 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 552

Last updated 2019-02-20

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-23
Primary Completion
2017-12-09
Completion
2017-12-09

Countries

  • Malaysia

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02617693 on ClinicalTrials.gov