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NCT03559621: MELINDA
Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes
NA trial testing mobile-based lifestyle intervention in Gestational Diabetes in 240 participants. Completed in 6 June 2023.
5 May 2023
Quick facts
| Lead sponsor | Universitaire Ziekenhuizen KU Leuven |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 240 |
| Start date | 14 April 2019 |
| Primary completion | 5 May 2023 |
| Estimated completion | 6 June 2023 |
| Sites | 7 locations across Belgium |
Drugs / interventions tested
- mobile-based lifestyle intervention
Conditions studied
- Gestational Diabetes — all drugs for Gestational Diabetes →
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
- Glucose Intolerance — all drugs for Glucose Intolerance →
- Healthy Lifestyle — all drugs for Healthy Lifestyle →
Sponsor
Universitaire Ziekenhuizen KU Leuven — full company profile →
Who can join
18 and older, female only, with Gestational Diabetes or Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mobile-Based Lifestyle Intervention in Women with Glucose Intolerance after Gestational Diabetes Mellitus (MELINDA), A Multicenter Randomized Controlled Trial: Methodology and Design.
Minschart C, Maes T, De Block C, Van Pottelbergh I, et al · · 2020 · cited 13× · PMID 32823771 · DOI 10.3390/jcm9082635 -
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.
Minschart C, Myngheer N, Maes T, De Block C, et al · · 2024 · cited 12× · PMID 38495521 · DOI 10.1016/j.eclinm.2024.102523 -
Lifestyle intervention to prevent type 2 diabetes after a pregnancy complicated by gestational diabetes mellitus: a systematic review and meta-analysis update.
Bracco PA, Reichelt AJ, Alves LF, Vidor PR, et al · · 2025 · cited 9× · PMID 39980013 · DOI 10.1186/s13098-025-01606-x -
Impact of breastfeeding on risk of glucose intolerance in early postpartum after gestational diabetes.
Vanlaer Y, Minschart C, Vrolijk H, Van Crombrugge P, et al · · 2024 · cited 2× · PMID 38933819 · DOI 10.3389/fendo.2024.1374682 -
The One-Hour Oral Glucose Tolerance Test to Predict Glucose Intolerance Postpartum in Women With Prior Gestational Diabetes.
Bochanen N, Vanlaer Y, Minschart C, Willems M, et al · · 2026 · PMID 41804216 · DOI 10.1111/dom.70634 -
Diabetes Risk Perception in Women with a Recent History of Gestational Diabetes Mellitus: A Secondary Analysis from a Belgian Randomized Controlled Trial (MELINDA Study).
Vanlaer Y, Minschart C, Snauwaert I, Myngheer N, et al · · 2025 · PMID 40725690 · DOI 10.3390/jcm14144998 -
Mental Health and Metabolic Outcomes in Early Postpartum in Women with Prediabetes After Gestational Diabetes: A Secondary Analysis of the MELINDA Trial.
Vanlaer Y, Minschart C, Van den Keybus K, Myngheer N, et al · · 2025 · PMID 40429596 · DOI 10.3390/jcm14103592
Verify or expand the search:
- PubMed search for NCT03559621
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03559621 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universitaire Ziekenhuizen KU Leuven
- Last refreshed: 15 September 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03559621.
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