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

NCT02617693 | Completed Phase 4

• 2 other identifiers: INS-4186U1111-1160-2987
• Study Type: interventional
• Target: 552
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Difference in waist circumference

  Months 0-8

Secondary Outcomes (12)

• Change in BMI (Body Mass Index)

  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 weight

  Month 0, Month 8

• Change in HbA1c (Glycosylated haemoglobin))

  Month 0, Month 8

Study Arms (2)

Standard of care

OTHER

Other: standard antenatal care

Life style intervention

EXPERIMENTAL

Behavioral: lifestyle intervention

Interventions

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.

Life style intervention

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.

Standard of care

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Seremban, Negeri Sembilan, 70400, Malaysia

Location

Related Publications (1)

• 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.

  PMID: 27117703 DERIVED

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 1, 2015
• Study Start: November 23, 2015
• Primary Completion: December 9, 2017
• Study Completion: December 9, 2017
• Last Updated: February 20, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share

Locations

MY (1)