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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1160-2987 | Other Identifier | WHO |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care | Other |
| |
| Life style intervention | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in waist circumference | Months 0-8 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novo Nordisk Investigational Site | Seremban, Negeri Sembilan | 70400 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27117703 | Derived | 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. |
| Label | URL |
|---|---|
| Clinical Trials at Novo Nordisk | View source |
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According to the Novo Nordisk disclosure commitment on novonordisk.com
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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. |
|
| Month 0, Month 8 |
| Change in weight | Month 0, Month 8 |
| Change in HbA1c (Glycosylated haemoglobin)) | 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 |
| Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ) | 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 |