Department of Biosciences and Nutrition, Karolinska Institutet, Huddinge, Sweden.
Department of Health, Medicine and Caring Sciences, Linköping University, Linköping, Sweden.
JMIR Mhealth Uhealth. 2021 Mar 11;9(3):e26091. doi: 10.2196/26091.
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.
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.
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.
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).
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.
ClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/13011.
怀孕期间体重过度增加（GWG）是一个主要的公共卫生问题，会对母婴双方的健康产生负面影响。需要采取可扩展的干预措施，而数字干预措施有可能接触到许多妇女，并促进健康的 GWG。以前大多数关于数字干预的研究都是小规模的试点研究，或者没有包括来自所有 BMI 类别的女性。因此，我们研究了一款智能手机应用程序在一个大样本（n=305）中的有效性，该样本涵盖了所有 BMI 类别。
比较健康妈妈应用程序（HealthyMoms app）干预与标准产科护理对 GWG、体脂肪、饮食习惯、中到高强度体力活动（MVPA）、血糖和胰岛素抵抗的影响。
进行了一项 2 臂平行随机对照试验。在瑞典厄斯特哥特兰的妇产科诊所招募了处于早孕阶段的女性。符合条件的女性在书面知情同意后完成基线测量，然后按照 1:1 的比例随机分配到干预组（n=152）或对照组（n=153）。对照组接受标准产科护理，而干预组在接受标准护理的基础上，再使用 HealthyMoms 智能手机应用程序 6 个月（该应用程序包含多种功能，如信息、推送通知、自我监测和 GWG、饮食和体力活动的反馈功能）。在基线（平均 13.9 [SD 0.7] 孕周）和随访（平均 36.4 [SD 0.4] 孕周）时评估了结果测量值。主要结局是 GWG，次要结局是体脂肪（Bod Pod）、饮食习惯（瑞典健康饮食指数），使用基于网络的 3 天饮食记录 Riksmaten FLEX，MVPA 使用 ActiGraph wGT3x-BT 加速度计，血糖和胰岛素抵抗。
总体而言，我们没有发现 GWG 有统计学上的显著效果（P=.62）；然而，数据表明干预的效果因孕前 BMI 而异，与对照组相比，孕前超重和肥胖的女性在干预组中体重增加较少（-1.33 公斤；95%CI -2.92 至 0.26；P=.10）和仅完成者分析（-1.67 公斤；95%CI -3.26 至 -0.09；P=.031]）。贝叶斯分析显示，超重和肥胖女性中，干预对 GWG 的影响有 99%的可能性，而这一影响超过 1 公斤的可能性为 81%。与对照组相比，干预组在随访时的瑞典健康饮食指数得分更高（0.27；95%CI 0.05-0.50；P=.017）。我们在随访时没有发现干预组和对照组在体脂肪、MVPA、血糖和胰岛素抵抗方面有统计学上的显著差异（P≥.21）。
尽管我们没有发现 GWG 的总体效果，但我们的结果表明，智能手机应用程序（HealthyMoms）有可能促进健康的饮食行为，并减少超重和肥胖女性在怀孕期间的体重增加。
ClinicalTrials.gov NCT03298555；https://clinicaltrials.gov/ct2/show/NCT03298555。
国际注册报告标识符（IRRID）：RR2-10.2196/13011。
