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  • Health promotion intervention among women with recent gestational diabetes mellitus: penetration, participation, and baseline findings from the Face-it randomized controlled trial

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Epidemiology/Health services research
Health promotion intervention among women with recent gestational diabetes mellitus: penetration, participation, and baseline findings from the Face-it randomized controlled trial
  1. Nanna Husted Jensen1,
  2. Karoline Kragelund Nielsen2,
  3. Inger Katrine Dahl-Petersen2,
  4. Ulla Kampmann3,4,
  5. Peter Damm5,6,
  6. Per Ovesen3,7,
  7. Elisabeth Reinhardt Mathiesen5,6,
  8. Christina Anne Vinter8,9,
  9. Emma Davidsen1,2,
  10. Maja Thøgersen1,2,
  11. Anne Timm1,2,
  12. Lise Lotte Torvin Andersen9,
  13. Sine Knorr3,
  14. Dorte Møller Jensen9,10,
  15. Helle Terkildsen Maindal1,2
  1. 1Department of Public Health, Aarhus University, Aarhus, Denmark
  2. 2Health Promotion Research, Copenhagen University Hospital - Steno Diabetes Center Copenhagen, Herlev, Denmark
  3. 3Steno Diabetes Center Aarhus, Aarhus, Denmark
  4. 4Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  5. 5Center for Pregnant Women with Diabetes, Departments of Endocrinology and Obstetrics, Rigshospitalet, Copenhagen, Denmark
  6. 6Department of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark
  7. 7Department of Obstetrics, Aarhus University Hospital, Aarhus, Denmark
  8. 8Department of Clinical Research, University of Southern Denmark, Odense, Denmark
  9. 9Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark
  10. 10Steno Diabetes Center Odense, Odense, Denmark
  1. Correspondence to Dr Nanna Husted Jensen; naje{at}ph.au.dk

Abstract

Introduction Face-it is a randomized controlled trial for women with recent gestational diabetes mellitus (GDM) and their families designed to evaluate the effect of a health promotion intervention on type 2 diabetes mellitus (T2DM) risk and quality of life. This study examined (1) the penetration and participation rates for the Face-it trial, (2) the characteristics of the participating women and the potential differences in characteristics according to partner participation status, and (3) representativity of the women at baseline.

Research design and methods We identified women with GDM during pregnancy and invited them and their partners to a baseline examination 10–14 weeks after delivery. Representativity was assessed by comparing the baseline participants with non-participating women, the general population of women with GDM delivering in Denmark, and populations from other intervention trials.

Results The penetration rate was 38.0% (867/2279) and the participation rate was 32.9% (285/867). The 285 women who attended baseline had a mean age of 32.7 (±4.8) years and body mass index (BMI) of 28.1 (±5.4) kg/m2, and 69.8% had a partner who participated. The women participating with a partner were more often primiparous, born in Denmark (82.8% vs 68.2%), were younger, and more often had a BMI ≤24.9 kg/m2 (35.7% vs 21.2%) compared with women without a partner. Compared with the general population of women with GDM in Denmark, these women broadly had similar degree of heterogeneity, but had higher rates of primiparity and singleton deliveries, and lower rates of preterm delivery and prepregnancy obesity.

Conclusions The penetration and participation rates were acceptable. We found a high rate of partner participation. Overall, women participating with a partner were comparable with those participating without a partner. Participating women were broadly similar to the general national GDM population, however with prepregnancy obesity, multiparity, preterm delivery, and multiple pregnancy being less represented.

Trial registration number NCT03997773.

  • Diabetes, Gestational
  • Health Promotion
  • Health Services Research
  • Public Health

Data availability statement

No data are available. Data from the Face-it trial are currently being analyzed. The data generated and analyzed during the current study are therefore not publicly available. Please contact the corresponding author in case of any questions regarding the data used for this study.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

https://doi.org/10.1136/bmjdrc-2023-003529

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    Data availability statement

    No data are available. Data from the Face-it trial are currently being analyzed. The data generated and analyzed during the current study are therefore not publicly available. Please contact the corresponding author in case of any questions regarding the data used for this study.

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    Footnotes

    • Contributors NHJ, KKN, IKD-P, and HTM conceived this study. NHJ was responsible for the overall content as the guarantor of this manuscript. The Face-it trial was conceived by HTM, KKN, IKD-P, DMJ, PO, and PD. All authors contributed to the Face-it trial design. NHJ wrote the first draft of this manuscript and carried out the analyses. All authors provided input to the manuscript. All authors approved the final manuscript.

    • Funding The Face-it study was funded by an unrestricted grant from the Novo Nordisk Foundation (NNF17OC0027826). NHJ was funded by a grant from Aarhus University.

    • Disclaimer The funding bodies had no role in the study design, data collection, analyses, or the decision to publish the results.

    • Competing interests KKN, IKD-P, UK, PO, CAV, ED, MT, AT, LLTA, SK, DMJ, and HTM are full time or part time employed at the Steno Diabetes Center in Copenhagen, Odense, or Aarhus. The Steno Diabetes Centers are regional public hospitals and research institutions partly funded by grants from Novo Nordisk Foundation.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.