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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile-based lifestyle intervention | Behavioral | one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| diabetes | development of type 2 diabetes based on the ADA criteria | 1 year |
| prediabetes | prevalence of prediabetes based on the ADA criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katrien Benhalima, MD PhD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OLV Aalst-Asse | Aalst | Oost-Vlaanderen | 9300 | Belgium | ||
| GZA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41804216 | Derived | 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. | |
| 38495521 |
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RCT with a mobile based lifestyle intervention
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| 6-16 weeks postpartum |
| prediabetes | prevalence of prediabetes based on the ADA criteria | 1 year postpartum |
| metabolic syndrome | development of a metabolic syndrome based on the WHO criteria | 1 year |
| metabolic syndrome | development of a metabolic syndrome based on the WHO criteria | 6-16 weeks postpartum |
| insulin resistance Matsuda | insulin resistance measured by Matsuda index | 1 year |
| insulin resistance HOMA-IR | insulin resistance measured by HOMA-IR | 1 year |
| beta-cell function ISSI-2 index | beta-cell function measured by ISSI-2 index | 1 year |
| beta-cell function insulinogenic index | beta-cell function measured by insulinogenic index | 1 year |
| beta-cell function HOMA-B | beta-cell function measured by HOMA-B | 1 year |
| weight loss | mean weight loss | 1 year |
| duration breastfeeding | self-designed questionnaire to evaluate duration of breastfeeding | 1 year |
| rate exclusive breastfeeding | self-designed questionnaire to evaluate rate of exclusive breastfeeding | 1 year |
| quality of life | SF-36 questionnaire | 1 year |
| depression | CES-D questionnaire | 1 year |
| anxiety | STAI-6 questionnaire | 1 year |
| motivation for behavior change | the TSRQ | 1 year |
| dietary quality | Flemish FFQ | 1 year |
| physical activity IPAQ | IPAQ questionnaire | 1 year |
| physical activity pedometer | pedometer | 1 year |
| diabetes risk perception | diabetes risk perception questionnaire | 1 year |
| Sence of Coherence | Sence of Coherence (SOC) questionnaire | 1 year |
| Antwerp |
| 2018 |
| Belgium |
| UZA | Antwerp | 2560 | Belgium |
| Imelda Bonheiden | Bonheiden | 2820 | Belgium |
| AZ Klina | Brasschaat | 2930 | Belgium |
| AZ Groeninge Kortrijk | Kortrijk | 8510 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| Derived |
| Minschart 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. |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| D018149 | Glucose Intolerance |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006943 | Hyperglycemia |
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