Effectiveness of a Step Counter Smartband and Midwife Counseling Intervention on Gestational Weight Gain and Physical Activity in Pregnant Women With Obesity (Pas and Pes Study): Randomized Controlled Trial

Abstract

Background Women who are pregnant and have obesity and excessive gestational weight gain (GWG) present a higher risk of maternal and perinatal complications. The use of mobile apps and a wristband during pregnancy may contribute to promoting healthy lifestyles and, thus, improving maternal and neonatal health. Objective This study aims to evaluate the effectiveness of a complex digital health intervention, using a smartband and app with midwife counseling, on GWG and physical activity (PA) in women who are pregnant and have obesity and analyze its impact on maternal and perinatal outcomes. In addition, we aim to study the frequency of use, usability, and satisfaction with the mobile apps used by the women in the intervention group. Methods A parallel, 2-arm, randomized controlled trial was conducted. A total of 150 women who were pregnant and had obesity were included. The intervention group received a complex combined digital intervention. The intervention was delivered with a smartband (Mi Band 2) linked to the app Mi Fit to measure PA and the Hangouts app with the midwife to provide personal health information. The control group received usual care. The validated Spanish versions of the International Physical Activity Questionnaire–Short Form and the System Usability Scale were used. Satisfaction was measured on a 1- to 5-point Likert scale. Results We analyzed 120 women, of whom 30 (25%) were withdrawn because of the COVID-19 pandemic. The median GWG in the intervention group was 7.0 (IQR 4-11) kg versus 9.3 (IQR 5.9-13.3) kg in the control group (P=.04). The adjusted mean GWG per week was 0.5 (95% CI 0.4-0.6) kg per week in the control group and 0.3 (95% CI 0.3-0.4) kg per week in the intervention group (df=0.1, 95% CI −0.2 to 0.03; P=.008). During the 35 and 37 gestational weeks, women in the intervention group had higher mean PA than women in the control group (1980 metabolic equivalents of tasks–minutes per week vs 1386 metabolic equivalents of tasks–minutes per week, respectively; P=.01). No differences were observed between the study groups in the incidence of maternal and perinatal outcomes. In the intervention group, 61% (36/59) of the women who were pregnant used the smartband daily, and 75% (44/59) evaluated the usability of the Mi Fit app as excellent. All women in the intervention group used the Hangouts app at least once a week. The mean of the satisfaction scale with the health counseling app and midwife support was 4.8/5 (SD 0.6) points. Conclusions The use of a complex mobile health intervention was associated with adequate GWG, which was lower in the intervention group than in the control group. In addition, we observed that the intervention group had increases in PA. No differences were observed in maternal perinatal complications. Trial Registration ClinicalTrials.gov NCT03706872; https://www.clinicaltrials.gov/ct2/show/NCT03706872

Physical activity during pregnancy: a systematic review for the assessment of current evidence with future recommendations

“…Pregnancy and infant outcomes were similar between groups Proportion of women who achieved gestational weight gain – 16 [ 47 ] 639 pregnant women IG 27.7 (5.6) CG 27.7 (5.7) 16-week exercise program starting between the 16th and 20th weeks of gestation, 3 times a week, lasting 60 min per session Children from women in the exercise group had higher language score at age 2 years and higher cognitive score (standardized at age 4 years. No effects of exercise during pregnancy were observed in the motor domain at 1, 2, and 4 years Preterm birth and preeclampsia – 17 [ 48 ] 150 pregnant women IG 32.4 (5.4) CG 33.4 (4.7) 10,000 steps a day, equivalent to 30 min per day of moderate physical activity over the week (≥ 5 days) During the 35 and 37 gestational weeks, women in the intervention group had higher mean PA than women in the control group ( p = 0.01) Maternal and perinatal outcomes – 18 [ 49 ] 90 pregnant women IG 29.46 (5.78) CG 28.94 (5.33) Virtual group in a social network (What's app) received individually diets and materials about that how to track its effect on their weight gain during pregnancy There was a statistically significant difference at the end of intervention in the level of daily physical activity ( p < 0.001) Amount of changes in the mean daily total physical activity level Measuring the level of changes in other subgroups of daily physical activity alongside with the level of weight gain during pregnancy 19 [ 50 ] 305 pregnant women 6-month digital lifestyle intervention (the HealthyMoms app) Digital lifestyle intervention is effective in promotion of healthy dietary habits in women representing all BMI-categories and decrease weight gain during pregnancy in women with overweight and obesity without compromising offspring growth Healthy weight gain, diet, and physical activity Body fatness, dietary habits, moderate-to-vigorous physical activity, glycemia, and insulin resistance 20 [ …”

Adipositasprävention in den ersten 1000 Tagen

“…Bislang wurden einige Studien, vor allem Pilot-Projekte, auf den Weg gebracht. Ein Wirksamkeitsnachweis Appgestützter Lebensstilinterventionen steht aus, wobei erste Ergebnisse durchaus positiv zu bewerten sind [55,57,60]…”

“…Bislang wurden einige Studien, vor allem Pilot-Projekte, auf den Weg gebracht. Ein Wirksamkeitsnachweis App-gestützter Lebensstilinterventionen steht aus, wobei erste Ergebnisse durchaus positiv zu bewerten sind 55 57 60 . In Deutschland bietet das neue digitale Versorgungsgesetz und die damit verbundene Möglichkeit für Ärzte digitale Gesundheitsanwendungen (DiGAs) als „Apps auf Rezept“ zu verschreiben, sowie die Einführung der elektronischen Patientenakte sinnvolle Rahmenbedingungen für zukünftige digitale Lösungen.…”

An mHealth Intervention to Reduce Gestational Obesity (mami-educ): Protocol for a Randomized Controlled Trial

“…Interventions based on behavioral theories provide a greater understanding of the underlying mechanisms that determine health-related behavior change and have the potential to be more effective in promoting adherence to weight gain control [ 28 ]. The social cognitive theory [ 29 , 30 ] considers the social dimension of the individual since each individual has a belief system and the capacity for self-motivation and positive behavioral changes [ 29 , 31 , 32 ]. Therefore, technologies such as mobile phones can be useful to effectively address this problem.…”