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Completed

NCT Number: NCT03559621

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

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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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Intolerance Glucose Metabolism Disorders Healthy Lifestyle Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Type 2 Diabetes Mellitus Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

OLV Aalst-Asse, Aalst, Oost-Vlaanderen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

  1. diabetes

    Time frame: 1 year

    development of type 2 diabetes based on the ADA criteria

  2. prediabetes

    Time frame: 6-16 weeks postpartum

    prevalence of prediabetes based on the ADA criteria

  3. prediabetes

    Time frame: 1 year postpartum

    prevalence of prediabetes based on the ADA criteria

  4. metabolic syndrome

    Time frame: 1 year

    development of a metabolic syndrome based on the WHO criteria

  5. metabolic syndrome

    Time frame: 6-16 weeks postpartum

    development of a metabolic syndrome based on the WHO criteria

  6. insulin resistance Matsuda

    Time frame: 1 year

    insulin resistance measured by Matsuda index

  7. insulin resistance HOMA-IR

    Time frame: 1 year

    insulin resistance measured by HOMA-IR

  8. beta-cell function ISSI-2 index

    Time frame: 1 year

    beta-cell function measured by ISSI-2 index

  9. beta-cell function insulinogenic index

    Time frame: 1 year

    beta-cell function measured by insulinogenic index

  10. beta-cell function HOMA-B

    Time frame: 1 year

    beta-cell function measured by HOMA-B

  11. weight loss

    Time frame: 1 year

    mean weight loss

  12. duration breastfeeding

    Time frame: 1 year

    self-designed questionnaire to evaluate duration of breastfeeding

  13. rate exclusive breastfeeding

    Time frame: 1 year

    self-designed questionnaire to evaluate rate of exclusive breastfeeding

  14. quality of life

    Time frame: 1 year

    SF-36 questionnaire

  15. depression

    Time frame: 1 year

    CES-D questionnaire

  16. anxiety

    Time frame: 1 year

    STAI-6 questionnaire

  17. motivation for behavior change

    Time frame: 1 year

    the TSRQ

  18. dietary quality

    Time frame: 1 year

    Flemish FFQ

  19. physical activity IPAQ

    Time frame: 1 year

    IPAQ questionnaire

  20. physical activity pedometer

    Time frame: 1 year

    pedometer

  21. diabetes risk perception

    Time frame: 1 year

    diabetes risk perception questionnaire

  22. Sence of Coherence

    Time frame: 1 year

    Sence of Coherence (SOC) questionnaire

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Acronym: MELINDA

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2018
Registry last updated
Sep 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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