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NCT03559621: MELINDA

Mobile-based Lifestyle Intervention in Women With Glucose Intolerance After Gestational Diabetes

Completed NA Last updated 15 September 2023
What this trial tests

NA trial testing mobile-based lifestyle intervention in Gestational Diabetes in 240 participants. Completed in 6 June 2023.

Timeline
14 April 2019
Primary endpoint
5 May 2023
6 June 2023

Quick facts

Lead sponsorUniversitaire Ziekenhuizen KU Leuven
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposeprevention
Enrollment240
Start date14 April 2019
Primary completion5 May 2023
Estimated completion6 June 2023
Sites7 locations across Belgium

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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:

Other recruiting trials for Gestational Diabetes

Currently open trials in the same condition.

Other Universitaire Ziekenhuizen KU Leuven trials

Trials by the same sponsor.

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Data sources for this page

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