DiabetesPhase 4Jom MamaNCT02617693
Development of Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
A Phase 4 study testing lifestyle intervention and standard antenatal care in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- lifestyle intervention and standard antenatal care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteMalaysia
- Study dates
- 23 Nov 2015to 9 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Female subject undergoing treatment for type 1 or 2 diabetes mellitus
- Subjects not residing in the district of Seremban
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Novo Nordisk Investigational Site
Seremban, Negeri Sembilan, 70400
About this study
Official title: Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
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
- Being tested
- lifestyle intervention, standard antenatal care
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lifestyle interventionBehavioural
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Other | Not described Receives: Other: standard antenatal care |
| Life style intervention | Experimental | Not described Receives: Behavioral: lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in waist circumference
Measured: Months 0-8
Secondary outcomes (12)
Change in BMI (Body Mass Index)
Measured: Month 0, Month 8
Change in waist-to-height ratio (WHtR)
Measured: Month 0, Month 8
Change in waist-to-hip ratio
Measured: Month 0, Month 8
Change in weight
Measured: Month 0, Month 8
Change in HbA1c (Glycosylated haemoglobin))
Measured: 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])
Measured: Month 0, Month 8
Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))
Measured: Month 0, Month 8
Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)
Measured: 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
Measured: Month 0, Month 8
Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)
Measured: 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
Measured: 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
Measured: Month 0, Month 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study start23 Nov 2015
- Primary completion9 Dec 2017
- Study completion9 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617693
- Sponsor's protocol ID
- INS-4186
- Other IDs
- U1111-1160-2987
- Acronym
- Jom Mama
- Status last verified
- Feb 2019
- First submitted
- 18 Nov 2015
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk.com
Publications
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.
PubMed 27117703
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jom Mama Project - Pre-pregnancy Intervention to Reduce the Risk of Diabetes and Prediabetes
- ClinicalTrials.gov ID
- NCT02617693
- Acronym / sponsor ID
- Jom Mama / INS-4186
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 9 Dec 2017 (actual)
- Study completion
- 9 Dec 2017 (actual)
- First posted
- 1 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Other | Other: standard antenatal care |
| Life style intervention | Experimental | Behavioral: lifestyle intervention |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Female subject undergoing treatment for type 1 or 2 diabetes mellitus
- Subjects not residing in the district of Seremban
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lifestyle interventionEvaluation 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. | Behavioural | Life style intervention |
| standard antenatal careStandard 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. | Other | Standard of care |
Primary outcome
Difference in waist circumference
Time frame: Months 0-8
12 secondary outcomes
Change in BMI (Body Mass Index)
Time frame: Month 0, Month 8
Change in waist-to-height ratio (WHtR)
Time frame: Month 0, Month 8
Change in waist-to-hip ratio
Time frame: Month 0, Month 8
Change in weight
Time frame: Month 0, Month 8
Change in HbA1c (Glycosylated haemoglobin))
Time frame: 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])
Time frame: Month 0, Month 8
Change in blood pressure (SBP (systolic blood pressure) and DBP(diastolic blood pressure))
Time frame: Month 0, Month 8
Change in the level of health literacy, as measured by the European Health Literacy Survey Questionnaire (HLC-EU-Q)
Time frame: 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
Time frame: Month 0, Month 8
Change in dietary intake, as measured by a Frequency Food Questionnaire (FFQ)
Time frame: 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
Time frame: 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
Time frame: Month 0, Month 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Derived from this study: PubMed 27117703Skau 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lifestyle intervention and standard antenatal care in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in waist circumference (time frame: Months 0-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.