Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial
Objective To test the effect of a complex, interdisciplinary, lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus during pregnancy and in the post partum.Design Single centred, single blinded, randomised, controlled trial (the M...
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BMJ Publishing Group
2024-02-01
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| Series: | BMJ Medicine |
| Online Access: | https://bmjmedicine.bmj.com/content/3/1/e000588.full |
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| author | Umberto Simeoni Antje Horsch Arnaud Chiolero Yvan Vial Nicole Sekarski Jardena J Puder Pascal Bovet Yvan Mivelaz Adina Mihaela Epure Bobby Stuijfzand Leah Gilbert Stefano Lanzi Justine Gross Didier Hans Stefano Di Bernardo Elena Gonzalez-rodriguez Alain Lacroix Jean-Benoît Rossel Dan Yedu Quansah Amar Arhab Sandrine Estoppey Younes Seyda Mayerat |
| author_facet | Umberto Simeoni Antje Horsch Arnaud Chiolero Yvan Vial Nicole Sekarski Jardena J Puder Pascal Bovet Yvan Mivelaz Adina Mihaela Epure Bobby Stuijfzand Leah Gilbert Stefano Lanzi Justine Gross Didier Hans Stefano Di Bernardo Elena Gonzalez-rodriguez Alain Lacroix Jean-Benoît Rossel Dan Yedu Quansah Amar Arhab Sandrine Estoppey Younes Seyda Mayerat |
| collection | DOAJ |
| description | Objective To test the effect of a complex, interdisciplinary, lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus during pregnancy and in the post partum.Design Single centred, single blinded, randomised, controlled trial (the MySweetheart trial).Setting Lausanne University Hospital, Switzerland, from 2 September 2016 to 25 October 2021.Participants 211 women aged at least 18 years with a diagnosis of gestational diabetes mellitus at 24-32 gestational weeks were randomly assigned (1:1) to the intervention (n=105) or to usual care (n=106).Interventions In addition to a comparator based on active guidelines for prepartum and postpartum usual care, the intervention consisted of four individual lifestyle visits during pregnancy and four interdisciplinary visits in the postpartum group, a peer support group workshop in pregnancy and post partum, and a bimonthly lifestyle coach support through telemedicine. The intervention focused on tailored behavioural and psychosocial strategies to improve diet, physical activity, mental health, social support, and adherence to gestational weight gain during pregnancy and weight retention recommendations.Main outcome measures Primary outcomes were between-group differences in the decrease in maternal weight and depression symptom scores between baseline and one year post partum. Secondary outcomes included changes in total and central body fat, anxiety, wellbeing, glycaemic parameters (homeostatic model assessment for insulin resistance (known as HOMA-IR) and Matsuda indices), aerobic fitness (maximal oxygen uptake), gestational weight gain, and weight retention. Assessors were blinded to primary and secondary outcomes.Results 84 (80%) of 105 women in the intervention and 95 (90%) of 106 in the usual care completed the study. There was not enough evidence of a difference in the decrease in weight (mean difference –0.38 kg (95% confidence interval –2.08 to 1.30)) or depression scores (–0.67 (–1.84 to 0.49)). The intervention led to an increase in fat-free mass (0.02 kg (0.01 to 0.03)). The intervention also decreased gestational weight gain since the first gestational diabetes mellitus visit (–1.20 kg (–2.14 to –0.26)) and weekly weight gain throughout the entire pregnancy (–0.14 kg (–0.25 to –0.03)), and led to a higher proportion of women without weight retention at one year post partum (34.1% (28/82) v 20.8% (20/96), P=0.034).Conclusions Compared with active usual care based on guidelines, there was not enough evidence to conclude that the intervention led to decrease in weight or depression symptoms. However, the intervention decreased gestational weight gain and increased the proportion of women without weight retention.Trial registration Clinicaltrials.gov NCT02890693. |
| format | Article |
| id | doaj-art-6e026080846e43cd95956d3d17fd85e5 |
| institution | Kabale University |
| issn | 2754-0413 |
| language | English |
| publishDate | 2024-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Medicine |
| spelling | doaj-art-6e026080846e43cd95956d3d17fd85e52025-02-03T10:00:10ZengBMJ Publishing GroupBMJ Medicine2754-04132024-02-013110.1136/bmjmed-2023-000588Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial 0Umberto SimeoniAntje Horsch1Arnaud Chiolero2Yvan VialNicole SekarskiJardena J Puder3Pascal Bovet4Yvan MivelazAdina Mihaela EpureBobby Stuijfzand5Leah Gilbert6Stefano Lanzi7Justine Gross8Didier Hans9Stefano Di BernardoElena Gonzalez-rodriguez10Alain Lacroix11Jean-Benoît Rossel12Dan Yedu Quansah13Amar Arhab14Sandrine Estoppey YounesSeyda Mayerat11 Kenya National Bureau of Statistics, Nairobi, Nairobi, KenyaInstitute of Higher Education and Research in Healthcare (IUFRS), University of Lausanne, Lausanne, SwitzerlandPopulation Health Laboratory (#PopHealthLab), University of Fribourg, Fribourg, SwitzerlandObstetric service, Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, Switzerland6 Center for Primary Care and Public Health (Unisanté), University of Lausanne, Lausanne, SwitzerlandObstetric service, Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, SwitzerlandObstetric service, Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, SwitzerlandHeart and Vessel Department, Division of Angiology, Lausanne University Hospital, Lausanne, SwitzerlandService of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, Lausanne, SwitzerlandInterdisciplinary Center of Bone Diseases, Bone and Joint Department, Lausanne University Hospital, Lausanne, SwitzerlandInterdisciplinary Center of Bone Diseases, Bone and Joint Department, Lausanne University Hospital, Lausanne, SwitzerlandObstetric service, Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, SwitzerlandUniversity of Bern, Bern, SwitzerlandCanadian Women`s Heart Health Centre, University of Ottawa Heart Institute, Ottawa, Ontario, CanadaObstetric service, Department Woman-Mother-Child, Lausanne University Hospital, Lausanne, SwitzerlandObjective To test the effect of a complex, interdisciplinary, lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus during pregnancy and in the post partum.Design Single centred, single blinded, randomised, controlled trial (the MySweetheart trial).Setting Lausanne University Hospital, Switzerland, from 2 September 2016 to 25 October 2021.Participants 211 women aged at least 18 years with a diagnosis of gestational diabetes mellitus at 24-32 gestational weeks were randomly assigned (1:1) to the intervention (n=105) or to usual care (n=106).Interventions In addition to a comparator based on active guidelines for prepartum and postpartum usual care, the intervention consisted of four individual lifestyle visits during pregnancy and four interdisciplinary visits in the postpartum group, a peer support group workshop in pregnancy and post partum, and a bimonthly lifestyle coach support through telemedicine. The intervention focused on tailored behavioural and psychosocial strategies to improve diet, physical activity, mental health, social support, and adherence to gestational weight gain during pregnancy and weight retention recommendations.Main outcome measures Primary outcomes were between-group differences in the decrease in maternal weight and depression symptom scores between baseline and one year post partum. Secondary outcomes included changes in total and central body fat, anxiety, wellbeing, glycaemic parameters (homeostatic model assessment for insulin resistance (known as HOMA-IR) and Matsuda indices), aerobic fitness (maximal oxygen uptake), gestational weight gain, and weight retention. Assessors were blinded to primary and secondary outcomes.Results 84 (80%) of 105 women in the intervention and 95 (90%) of 106 in the usual care completed the study. There was not enough evidence of a difference in the decrease in weight (mean difference –0.38 kg (95% confidence interval –2.08 to 1.30)) or depression scores (–0.67 (–1.84 to 0.49)). The intervention led to an increase in fat-free mass (0.02 kg (0.01 to 0.03)). The intervention also decreased gestational weight gain since the first gestational diabetes mellitus visit (–1.20 kg (–2.14 to –0.26)) and weekly weight gain throughout the entire pregnancy (–0.14 kg (–0.25 to –0.03)), and led to a higher proportion of women without weight retention at one year post partum (34.1% (28/82) v 20.8% (20/96), P=0.034).Conclusions Compared with active usual care based on guidelines, there was not enough evidence to conclude that the intervention led to decrease in weight or depression symptoms. However, the intervention decreased gestational weight gain and increased the proportion of women without weight retention.Trial registration Clinicaltrials.gov NCT02890693.https://bmjmedicine.bmj.com/content/3/1/e000588.full |
| spellingShingle | Umberto Simeoni Antje Horsch Arnaud Chiolero Yvan Vial Nicole Sekarski Jardena J Puder Pascal Bovet Yvan Mivelaz Adina Mihaela Epure Bobby Stuijfzand Leah Gilbert Stefano Lanzi Justine Gross Didier Hans Stefano Di Bernardo Elena Gonzalez-rodriguez Alain Lacroix Jean-Benoît Rossel Dan Yedu Quansah Amar Arhab Sandrine Estoppey Younes Seyda Mayerat Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial BMJ Medicine |
| title | Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial |
| title_full | Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial |
| title_fullStr | Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial |
| title_full_unstemmed | Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial |
| title_short | Effect of a prepartum and postpartum, complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus (the MySweetheart trial): randomised, single centred, blinded, controlled trial |
| title_sort | effect of a prepartum and postpartum complex interdisciplinary lifestyle and psychosocial intervention on metabolic and mental health outcomes in women with gestational diabetes mellitus the mysweetheart trial randomised single centred blinded controlled trial |
| url | https://bmjmedicine.bmj.com/content/3/1/e000588.full |
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