Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
NCT ID: NCT02617693
Last Updated: 2019-02-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
552 participants
INTERVENTIONAL
2015-11-23
2017-12-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Standard of care
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.
Life style intervention
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Subjects not residing in the district of Seremban
FEMALE
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Seremban, Negeri Sembilan, , Malaysia
Countries
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References
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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.
Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1160-2987
Identifier Type: OTHER
Identifier Source: secondary_id
INS-4186
Identifier Type: -
Identifier Source: org_study_id
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