Gestational DiabetesMELINDANCT03559621
Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
A study testing mobile-based lifestyle intervention in people with Gestational Diabetes and Type 2 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in Belgium.
Trial summary
Although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (GDM) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Type 2 Diabetes Mellitus, Glucose Intolerance
- What is being tested?
- mobile-based lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesBelgium
- Study dates
- 14 Apr 2019to 6 Jun 2023
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or older
- GDM based on the 2013 WHO criteria
- glucose intolerance (prediabetes based on the ADA criteria) based on the 75g OGTT 6-16 weeks after delivery
Who cannot join
- diabetes;
- current use of metformin;
- normal glucose tolerance (ADA criteria);
- health limitations or treatments which would restrict the participation in the intervention trial.
- Has no smartphone
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Belgium7 sites
OLV Aalst-Asse
Aalst, Oost-Vlaanderen, 9300
GZA
Antwerp, 2018
UZA
Antwerp, 2560
Imelda Bonheiden
Bonheiden, 2820
AZ Klina
Brasschaat, 2930
AZ Groeninge Kortrijk
Kortrijk, 8510
UZ Leuven
Leuven, 3000
About this study
Although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (GDM) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. The low participating rates in many studies using individual or group sessions, reflect how difficult it is to engage women in the first years postpartum. Since women with glucose intolerance (prediabetes) have the highest risk to develop type 2 diabetes (T2DM), we designed the MELINDA pilot study, a randomized controlled trial with 1 year of follow-up to evaluate the efficacy and feasibility of a telephone -and mobile (app) based lifestyle coaching intervention in women with glucose intolerance after a recent history of GDM to promote a healthy lifestyle.
- Being tested
- mobile-based lifestyle intervention
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 2, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile-based lifestyle interventionBehavioural
one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | Women in the control group will receive follow-up as in normal routine with referral to primary care. They will receive an OGTT after 1 year as part of the trial. |
| intervention group | Other | A mobile-based lifestyle intervention Receives: Behavioral: mobile-based lifestyle intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight-loss goal
reaching the weight-loss goal ≥5% of body weight when overweight or obese or returning to pre-gravid weight if normal BMI
Measured: 1 year
Secondary outcomes (22)
diabetes
development of type 2 diabetes based on the ADA criteria
Measured: 1 year
prediabetes
prevalence of prediabetes based on the ADA criteria
Measured: 6-16 weeks postpartum
prediabetes
prevalence of prediabetes based on the ADA criteria
Measured: 1 year postpartum
metabolic syndrome
development of a metabolic syndrome based on the WHO criteria
Measured: 1 year
metabolic syndrome
development of a metabolic syndrome based on the WHO criteria
Measured: 6-16 weeks postpartum
insulin resistance Matsuda
insulin resistance measured by Matsuda index
Measured: 1 year
insulin resistance HOMA-IR
insulin resistance measured by HOMA-IR
Measured: 1 year
beta-cell function ISSI-2 index
beta-cell function measured by ISSI-2 index
Measured: 1 year
beta-cell function insulinogenic index
beta-cell function measured by insulinogenic index
Measured: 1 year
beta-cell function HOMA-B
beta-cell function measured by HOMA-B
Measured: 1 year
weight loss
mean weight loss
Measured: 1 year
duration breastfeeding
self-designed questionnaire to evaluate duration of breastfeeding
Measured: 1 year
rate exclusive breastfeeding
self-designed questionnaire to evaluate rate of exclusive breastfeeding
Measured: 1 year
quality of life
SF-36 questionnaire
Measured: 1 year
depression
CES-D questionnaire
Measured: 1 year
anxiety
STAI-6 questionnaire
Measured: 1 year
motivation for behavior change
the TSRQ
Measured: 1 year
dietary quality
Flemish FFQ
Measured: 1 year
physical activity IPAQ
IPAQ questionnaire
Measured: 1 year
physical activity pedometer
pedometer
Measured: 1 year
diabetes risk perception
diabetes risk perception questionnaire
Measured: 1 year
Sence of Coherence
Sence of Coherence (SOC) questionnaire
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start14 Apr 2019
- Primary completion5 May 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- RCT with a mobile based lifestyle intervention
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrien Benhalima, MD PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559621
- Sponsor's protocol ID
- the Melinda study
- Acronym
- MELINDA
- Status last verified
- Sep 2023
- First submitted
- 23 May 2018
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bochanen N, Vanlaer Y, Minschart C, Willems M, Myngheer N, Maes T, van Pottelbergh I, Abrams P, Vinck W, Leuridan L, Driessens S, Billen J, Laenen A, de Block C, Benhalima K. The One-Hour Oral Glucose Tolerance Test to Predict Glucose Intolerance Postpartum in Women With Prior Gestational Diabetes. Diabetes Obes Metab. 2026 Jun;28(6):4619-4629. doi: 10.1111/dom.70634. Epub 2026 Mar 9.
PubMed 41804216Minschart C, Myngheer N, Maes T, De Block C, Van Pottelbergh I, Abrams P, Vinck W, Leuridan L, Driessens S, Mathieu C, Billen J, Matthys C, Laenen A, Bogaerts A, Benhalima K. Effectiveness of a blended mobile-based lifestyle intervention in women with glucose intolerance after a recent history of gestational diabetes (MELINDA): a 1-year, prospective, multicentre, randomised controlled trial. EClinicalMedicine. 2024 Mar 8;70:102523. doi: 10.1016/j.eclinm.2024.102523. eCollection 2024 Apr.
PubMed 38495521
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03559621
- Acronym / sponsor ID
- MELINDA / the Melinda study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 18 Jun 2018 (actual)
- 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.
Although lifestyle modification programs have been shown to be effective in preventing diabetes in older populations, interventions in women with recent gestational diabetes (GDM) clearly need to be adapted to address their unique barriers to behavior change in order to optimize adherence. The low participating rates in many studies using individual or group sessions, reflect how difficult it is to engage women in the first years postpartum. Since women with glucose intolerance (prediabetes) have the highest risk to develop type 2 diabetes (T2DM), we designed the MELINDA pilot study, a randomized controlled trial with 1 year of follow-up to evaluate the efficacy and feasibility of a telephone -and mobile (app) based lifestyle coaching intervention in women with glucose intolerance after a recent history of GDM to promote a healthy lifestyle.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- RCT with a mobile based lifestyle intervention
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Women in the control group will receive follow-up as in normal routine with referral to primary care. They will receive an OGTT after 1 year as part of the trial. |
| intervention group | Other | Behavioral: mobile-based lifestyle interventionA mobile-based lifestyle intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 or older
- GDM based on the 2013 WHO criteria
- glucose intolerance (prediabetes based on the ADA criteria) based on the 75g OGTT 6-16 weeks after delivery
Key exclusion criteria (5 listed)
- diabetes;
- current use of metformin;
- normal glucose tolerance (ADA criteria);
- health limitations or treatments which would restrict the participation in the intervention trial.
- Has no smartphone
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 |
|---|---|---|
| mobile-based lifestyle interventionone face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed | Behavioural | intervention group |
Primary outcome
weight-loss goal
Time frame: 1 year
reaching the weight-loss goal ≥5% of body weight when overweight or obese or returning to pre-gravid weight if normal BMI
22 secondary outcomes
diabetes
Time frame: 1 year
prediabetes
Time frame: 6-16 weeks postpartum
prediabetes
Time frame: 1 year postpartum
metabolic syndrome
Time frame: 1 year
metabolic syndrome
Time frame: 6-16 weeks postpartum
insulin resistance Matsuda
Time frame: 1 year
insulin resistance HOMA-IR
Time frame: 1 year
beta-cell function ISSI-2 index
Time frame: 1 year
beta-cell function insulinogenic index
Time frame: 1 year
beta-cell function HOMA-B
Time frame: 1 year
weight loss
Time frame: 1 year
duration breastfeeding
Time frame: 1 year
rate exclusive breastfeeding
Time frame: 1 year
quality of life
Time frame: 1 year
depression
Time frame: 1 year
anxiety
Time frame: 1 year
motivation for behavior change
Time frame: 1 year
dietary quality
Time frame: 1 year
physical activity IPAQ
Time frame: 1 year
physical activity pedometer
Time frame: 1 year
diabetes risk perception
Time frame: 1 year
Sence of Coherence
Time frame: 1 year
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 15 Sep 2023.
- Derived from this study: PubMed 41804216Bochanen N, Vanlaer Y, Minschart C, Willems M, Myngheer N, Maes T, van Pottelbergh I, Abrams P, Vinck W, Leuridan L, Driessens S, Billen J, Laenen A, de Block C, Benhalima K. The One-Hour Oral Glucose Tolerance Test to Predict Glucose Intolerance Postpartum in Women With Prior Gestational Diabetes. Diabetes Obes Metab. 2026 Jun;28(6):4619-4629. doi: 10.1111/dom.70634. Epub 2026 Mar 9.
- Derived from this study: PubMed 38495521Minschart C, Myngheer N, Maes T, De Block C, Van Pottelbergh I, Abrams P, Vinck W, Leuridan L, Driessens S, Mathieu C, Billen J, Matthys C, Laenen A, Bogaerts A, Benhalima K. Effectiveness of a blended mobile-based lifestyle intervention in women with glucose intolerance after a recent history of gestational diabetes (MELINDA): a 1-year, prospective, multicentre, randomised controlled trial. EClinicalMedicine. 2024 Mar 8;70:102523. doi: 10.1016/j.eclinm.2024.102523. eCollection 2024 Apr.
- Individual participant dataSharing planned: No
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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.
Katrien Benhalima, MD PhD principal investigator
UZ Leuven
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile-based lifestyle intervention in people with Gestational Diabetes and Type 2 Diabetes Mellitus, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in Belgium.
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 3 inclusion and 5 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 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Belgium. 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.
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?
weight-loss goal (time frame: 1 year). 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 NCT03559621, which also lists 2 linked publications.
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 15 Sep 2023.