نبذة مختصرة : This study was funded by the Swedish Research Council (2016-01147 to ML) and additionally supported by the Swedish Research Council for Health, Working Life and Welfare (Forte, 2017-00088 to PH; 2018-01410 to ML); Bo and Vera Ax:son Johnsons' Foundation (to ML); the Strategic Research Area Health Care Science, Karolinska Institutet/Umea University (to PH); the Swedish Society of Medicine (to PH); Karolinska Institutet (to PH); Lions Forskningsfond (to PH); and ALF Grants, Region Ostergotland (ML). MHL was supported by a grant from Yrjo Jahnsson Foundation. The funders had no role in study design, conduct, or reporting of the trial. The authors thank all the participants in the trial as well as Eva Flinke and Ellinor Nilsson for invaluable help with data collection, the midwives in Region Ostergotland for help with the recruitment, Hanna Henriksson and Christina Alexandrou for valuable help developing the content of the app, Jan Fjellstrom and Nils Lidstrom at ScientificMed for development of the app and technical support, and Anna Karin Lindroos and Eva Warensjo Lemming for support with the Riksmaten FLEX method (adaptations, data processing, and interpretation of results).
Background: Excessive gestational weight gain (GWG) during pregnancy is a major public health concern associated with negative health outcomes for both mother and child. Scalable interventions are needed, and digital interventions have the potential to reach many women and promote healthy GWG. Most previous studies of digital interventions have been small pilot studies or have not included women from all BMI categories. We therefore examined the effectiveness of a smartphone app in a large sample (n=305) covering all BMI categories. Objective: To investigate the effectiveness of a 6-month intervention (the HealthyMoms app) on GWG, body fatness, dietary habits, moderate-to-vigorous physical activity (MVPA), glycemia, and insulin resistance in comparison to standard maternity care. Methods: A 2-arm parallel randomized controlled trial was conducted. Women in early pregnancy at maternity clinics in Östergötland, Sweden, were recruited. Eligible women who provided written informed consent completed baseline measures, before being randomized in a 1:1 ratio to either an intervention (n=152) or control group (n=153). The control group received standard maternity care while the intervention group received the HealthyMoms smartphone app for 6 months (which includes multiple features, eg, information; push notifications; self-monitoring; and feedback features for GWG, diet, and physical activity) in addition to standard care. Outcome measures were assessed at Linköping University Hospital at baseline (mean 13.9 [SD 0.7] gestational weeks) and follow-up (mean 36.4 [SD 0.4] gestational weeks). The primary outcome was GWG and secondary outcomes were body fatness (Bod Pod), dietary habits (Swedish Healthy Eating Index) using the web-based 3-day dietary record Riksmaten FLEX, MVPA using the ActiGraph wGT3x-BT accelerometer, glycemia, and insulin resistance. Results: Overall, we found no statistically significant effect on GWG (P=.62); however, the data indicate that the effect of the intervention differed by pre-pregnancy BMI, as women with overweight and obesity before pregnancy gained less weight in the intervention group as compared with the control group in the imputed analyses (–1.33 kg; 95% CI –2.92 to 0.26; P=.10) and completers-only analyses (–1.67 kg; 95% CI –3.26 to –0.09; P=.031]). Bayesian analyses showed that there was a 99% probability of any intervention effect on GWG among women with overweight and obesity, and an 81% probability that this effect was over 1 kg. The intervention group had higher scores for the Swedish Healthy Eating Index at follow-up than the control group (0.27; 95% CI 0.05-0.50; P=.017). We observed no statistically significant differences in body fatness, MVPA, glycemia, and insulin resistance between the intervention and control group at follow up (P≥.21). Conclusions: Although we found no overall effect on GWG, our results demonstrate the potential of a smartphone app (HealthyMoms) to promote healthy dietary behaviors as well as to decrease weight gain during pregnancy in women with overweight and obesity.
Swedish Research Council European Commission 2016-01147
Swedish Research Council
Swedish Research Council for Health Working Life & Welfare (Forte) 2017-00088 2018-01410
Vera Ax:son Johnsons' Foundation
Strategic Research Area Health Care Science, Karolinska Institutet/Umea University
Swedish Society of Medicine
Karolinska Institutet
Lions Forskningsfond
ALF Grants, Region Ostergotland
Yrjo Jahnsson Foundation
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