Dataset Information

Effectiveness of a Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Randomized Controlled Trial.

ABSTRACT:

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.

Trial registration

ClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555.

International registered report identifier (irrid)

RR2-10.2196/13011.

SUBMITTER: Sandborg J

PROVIDER: S-EPMC7995071 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundExcessive gestational weight gain (GWG) is common and associated with negative health outcomes for both mother and child. Mobile health-delivered lifestyle interventions offer the potential to mitigate excessive GWG. The effectiveness of a smartphone app (HealthyMoms) was recently evaluated in a randomized controlled trial. To explore the users' experiences of using the app, a qualitative study within the HealthyMoms trial was performed.ObjectiveThis qualitative study explored participants' engagement and satisfaction with the 6-month usage of the HealthyMoms app.MethodsA total of 19 women (mean age: 31.7, SD 4.4 years; mean BMI: 24.6, SD 3.4 kg/m2; university degree attainment: 13/19, 68%; primiparous: 11/19, 58%) who received the HealthyMoms app in a randomized controlled trial completed semistructured exit interviews. The interviews were audiorecorded and fully transcribed, coded, and analyzed using thematic analysis with an inductive approach.ResultsThematic analysis revealed a main theme and 2 subthemes. The main theme, "One could suit many: a multifunctional tool to strengthen women's health during pregnancy," and the 2 subthemes, "Factors within and beyond the app influence app engagement" and "Trust, knowledge, and awareness: aspects that can motivate healthy habits," illustrated that a trustworthy and appreciated health and pregnancy app that is easy to use can inspire a healthy lifestyle during pregnancy. The first subtheme discussed how factors within the app (eg, regular updates and feedback) were perceived to motivate both healthy habits and app engagement. Additionally, factors beyond the app were described to both motivate (eg, interest, motivation, and curiosity) and limit (eg, pregnancy-related complications, lack of time) app engagement. The second subtheme reflected important aspects, such as high trustworthiness of the app, increased knowledge, and awareness from using the app, which motivated participants to improve or maintain healthy habits during pregnancy.ConclusionsThe HealthyMoms app was considered a valuable and trustworthy tool to mitigate excessive GWG, with useful features and relevant information to initiate and maintain healthy habits during pregnancy.Trial registrationClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555.International registered report identifier (irrid)RR2-10.2196/13011.

Project description:Approximately 50% of women gain excessive weight in pregnancy. Optimizing gestational weight gain is important for the short- and long-term health of the childbearing woman and her baby. Despite this, there is no recommendation for routine weighing in pregnancy, and weight is a topic that many maternity care providers avoid. Resource-intensive interventions have mainly targeted overweight and obese women with variable results. Few studies have examined the way that socioeconomic status might influence the effectiveness or acceptability of an intervention to participants. Given the scale of the problem of maternal weight gain, maternity services will be unlikely to sustain resource intensive interventions; therefore, innovative strategies are required to assist women to manage weight gain in pregnancy.The primary aim of the trial was to examine the effectiveness of the Eating4Two smartphone app in assisting women of all body mass index categories to optimize gestational weight gain. Secondary aims include comparing childbirth outcomes and satisfaction with antenatal care and examining the way that relative advantage and disadvantage might influence engagement with and acceptability of the intervention.This randomized controlled trial will randomize 1330 women to control or intervention groups in 3 regions of different socioeconomic status. Women will be recruited from clinical and social media sites. The intervention group will be provided with access to the Eating4Two mobile phone app which provides nutrition and dietary information specifically tailored for pregnancy, advice on food serving sizes, and a graph that illustrates women's weight change in relation to the range recommended by the Institute of Medicine. Women will be encouraged to use the app to prompt conversations with their maternity care providers about weight gain in pregnancy. The control group will receive routine antenatal care.Recruitment has commenced though the recruitment rate is slower than expected. Additional funds are required to employ research assistants and promote the study in an advertising campaign.Feasibility testing highlighted the inadequacy of the original recruitment strategy and the need to provide the app in both major platforms (Android and iOS). Smartphone technologies may offer an effective alternative to resource intensive strategies for assisting women to optimize weight gain in pregnancy.Australian New Zealand Clinical Trials Registry ACTRN12617000169347; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=371470 (Archived by WebCite at http://www.webcitation.org /6zDvgw5bo).RR1-10.2196/9920.

Project description:BackgroundGestational weight gain (GWG) has important health implications for both the mother and offspring. Maternal diet during pregnancy may play an important role in achieving adequate GWG, although its precise role is unclear.ObjectivesAssociations between maternal dietary components (fruits and vegetables, added sugar, percentage energy from fat, dairy) and GWG were examined in 327 pregnant women from the Archive for Research on Child Health cohort.MethodsSelf-reported usual dietary intake was assessed with validated dietary screening tools at the first prenatal visit. GWG was obtained from the birth certificate and was categorized as inadequate, adequate, or excessive according to the Institute of Medicine recommendations. Associations between dietary components and GWG were assessed using multivariable regression models, stratified by maternal prepregnancy BMI category.ResultsOnly 31.5% of women had adequate GWG, with 24.8% gaining insufficient weight and 43.7% gaining excessively. Women who consumed more fruits and vegetables were suggestively less likely to have excessive GWG (OR: 0.86; 95% CI: 0.75, 1.00) in the minimally adjusted model, but the association became nonsignificant after adjusting for covariates (OR: 0.89; 95% CI: 0.77, 1.03). In stratified models, higher fruit and vegetable intake was linked to lower likelihood of excessive GWG among women with obesity (OR: 0.77; 95% CI: 0.60, 0.97), whereas higher added sugar intake was linked to a slight reduction in likelihood of excessive GWG (OR: 0.91; 95% CI: 0.84, 0.99) among women with a prepregnancy BMI in the normal range. Other dietary components were not significantly associated with GWG.ConclusionsThese results suggest that consuming fruits and vegetables during pregnancy may reduce risk of excessive GWG among women with obesity. With the rising prevalence of obesity among women of reproductive age, interventions to increase fruit and vegetable intake during pregnancy may have broad public health impact by improving maternal and child health outcomes.

Project description:Childhood overweight and obesity is a public health priority. We have previously reported the efficacy of a parent-oriented mobile health (mHealth) app-based intervention (MINISTOP 1.0) which showed improvements in healthy lifestyle behaviors. However, the effectiveness of the MINISTOP app in real-world conditions needs to be established. To evaluate the real-world effectiveness of a 6-month mHealth intervention (MINISTOP 2.0 app) on children's intake of fruits, vegetables, sweet and savory treats, sweet drinks, moderate-to-vigorous physical activity, and screen time (primary outcomes), and on parental self-efficacy (PSE) for promoting healthy lifestyle behaviors, and children's body mass index (BMI) (secondary outcomes). A hybrid type 1 effectiveness-implementation design was utilized. For the effectiveness outcomes, a two-arm, individually randomized controlled trial was conducted. Parents (n = 552) of 2.5-to-3-year-old children were recruited from 19 child health care centers across Sweden, and, randomized to either a control (standard care) or intervention group (MINISTOP 2.0 app). The 2.0 version was adapted and translated into English, Somali and Arabic to increase reach. All recruitment and data collection were conducted by the nurses. Outcomes were assessed at baseline and after six months, using standardized measures (BMI) and a questionnaire (health behaviors, PSE). Among the participating parents (n = 552, age: 34.1 ± 5.0 years), 79% were mothers and 62% had a university degree. Twenty-four percent (n = 132) of children had two foreign-born parents. At follow-up, parents in the intervention group reported lower intakes of sweet and savory treats (-6.97 g/day; p = 0.001), sweet drinks (-31.52 g/day; p < 0.001), and screen time (-7.00 min/day; p = 0.012) in their children compared to the control group. The intervention group reported higher total PSE (0.91; p = 0.006), PSE for promoting healthy diet (0.34; p = 0.008) and PSE for promoting physical activity behaviors (0.31; p = 0.009) compared to controls. No statistically significant effect was observed for children's BMI z-score. Overall, parents reported high satisfaction with the app, and 54% reported using the app at least once a week. Children in the intervention group had lower intakes of sweet and savory treats, sweet drinks, less screen time (primary outcomes) and their parents reported higher PSE for promoting healthy lifestyle behaviors. Our results from this real-world effectiveness trial support the implementation of the MINISTOP 2.0 app within Swedish child health care. Clinicaltrials.gov NCT04147039; https://clinicaltrials.gov/ct2/show/NCT04147039.

Project description:BackgroundChanging current dietary patterns into sustainable healthy diets (ie, healthy diets with low environmental impact and socioeconomic fairness) is urgent. So far, few eating behavior change interventions have addressed all the dimensions of sustainable healthy diets at once and used cutting-edge methods from the field of digital health behavior change.ObjectiveThe primary objectives of this pilot study were to assess the feasibility and effectiveness of an individual behavior change intervention toward the adoption of a more environmentally sustainable healthy diet as a whole and changes in specific relevant food groups, food waste, and obtaining food from fair sources. The secondary objectives included the identification of mechanisms of action that potentially mediate the effect of the intervention on behaviors, identification of potential spillover effects and covariations among different food outcomes, and identification of the role of socioeconomic status in behavior changes.MethodsWe will run a series of ABA n-of-1 trials over a year, with the first A phase corresponding to a 2-week baseline evaluation, the B phase to a 22-week intervention, and the second A phase to a 24-week postintervention follow-up. We plan to enroll 21 participants from low, middle, and high socioeconomic statuses, with 7 from each socioeconomic group. The intervention will involve sending text messages and providing brief individualized web-based feedback sessions based on regular app-based assessments of eating behavior. The text messages will contain brief educational messages on human health and the environmental and socioeconomic effects of dietary choices; motivational messages to encourage the adoption of sustainable healthy diets by participants, providing tips to achieve their own behavioral goals; or links to recipes. Both quantitative and qualitative data will be collected. Quantitative data (eg, on eating behaviors and motivation) will be collected through self-reported questionnaires on several weekly bursts spread through the study. Qualitative data will be collected through 3 individual semistructured interviews before the intervention period, at the end of the intervention period, and at the end of the study. Analyses will be performed at both the individual and group levels depending on the outcome and objective.ResultsThe first participants were recruited in October 2022. The final results are expected by October 2023.ConclusionsThe results of this pilot study will be useful for designing future larger interventions on individual behavior change for sustainable healthy diets.International registered report identifier (irrid)PRR1-10.2196/41443.

Project description:BackgroundChildhood obesity is still a major health problem in many countries, including Sweden. Childhood obesity and obesity-related behaviours in childhood, such as low physical activity and unhealthy eating habits, tend to track into adulthood, which highlights the need for early prevention. Our aims are to evaluate whether a parent-oriented mobile health app (the MINISTOP 2.0 app) integrated into primary child health care can improve diet and physical activity behaviours and reduce the prevalence of overweight and obesity in preschool-aged children as well as to evaluate the implementation among child health care nurses and parents.MethodsThis trial uses a hybrid type 1 effectiveness-implementation design. Families (n = 500) who attend a routine visit to one of 15-20 primary child health care centres throughout Sweden, when their child is 2.5 years, are offered participation in a randomised controlled trial (effectiveness evaluation). After acceptance, families will be randomised (1:1) to control or intervention groups. The intervention group receives a 6-month parent-oriented smartphone intervention aimed at improving the dietary and activity behaviours of their child (the MINISTOP 2.0 app) and the control group receives routine child health care. Dietary habits, physical activity and screen time (primary outcomes), body weight and height in children, and parental self-efficacy (secondary outcomes) are measured at baseline and at 6 months post randomisation. Implementation outcomes (i.e. perceived acceptability, appropriateness, and feasibility) of the intervention will be assessed among primary child health care nurses and parents in the trial through questionnaires and qualitative interviews.DiscussionThis trial will evaluate whether the MINISTOP 2.0 app can be used in primary child health care to improve diet and physical activity behaviours, and prevent overweight and obesity, in preschool-aged children. If effectiveness is proven, and the MINISTOP 2.0 app is considered acceptable, appropriate and feasible, it can be implemented nationally as part of the preventive strategies to combat childhood obesity provided by routine child health care.Trial registrationThe trial was registered at the Clinicaltrials.gov register platform (ID NCT04147039 ) on 31 October 2019.

Project description:BackgroundExcessive gestational weight gain (GWG) and gestational diabetes mellitus (GDM) are common pregnancy complications that have been shown to be preventable through the use of lifestyle interventions. However, a significant gap exists between research on pregnancy lifestyle interventions and translation into clinical practice. App-supported interventions might aid in overcoming previous implementation barriers. The current status in this emerging research area is unknown.ObjectiveThis scoping review aims to provide a comprehensive overview of planned, ongoing, and completed studies on eHealth and mobile health (mHealth) app-supported lifestyle interventions in pregnancy to manage GWG and prevent GDM. The review assesses the scope of the literature in the field; describes the population, intervention, control, outcomes, and study design (PICOS) characteristics of included studies as well as the findings on GWG and GDM outcomes; and examines app functionalities.MethodsThe scoping review was conducted according to a preregistered protocol and followed established frameworks. Four electronic databases and 2 clinical trial registers were systematically searched. All randomized and quasi-randomized controlled trials (RCTs) of app-supported lifestyle interventions in pregnancy and related qualitative and quantitative research across the different study phases were considered for inclusion. Eligible studies and reports of studies were included until June 2022. Extracted data were compiled in descriptive analyses and reported in narrative, tabular, and graphical formats.ResultsThis review included 97 reports from 43 lifestyle intervention studies. The number of published reports has steadily increased in recent years; of the 97 included reports, 38 (39%) were trial register entries. Of the 39 identified RCTs, 10 efficacy or effectiveness trials and 8 pilot trials had published results on GWG (18/39, 46%); of these 18 trials, 7 (39%) trials observed significant intervention effects on GWG outcomes. Of all 39 RCTs, 5 (13%) efficacy or effectiveness trials reported GDM results, but none observed significant intervention effects on GDM. The RCTs included in the review were heterogeneous in terms of their PICOS characteristics. Most of the RCTs were conducted in high-income countries, included women with overweight or obesity and from all BMI categories, delivered multicomponent interventions, delivered interventions during pregnancy only, and focused on diet and physical activity. The apps used in the studies were mostly mHealth apps that included features for self-monitoring, feedback, goal setting, prompts, and educational content. Self-monitoring was often supported by wearable activity monitors and Bluetooth-connected weight scales.ConclusionsResearch in this field is nascent, and the effectiveness and implementability of app-supported interventions have yet to be determined. The complexity and heterogeneity of intervention approaches pose challenges in identifying the most beneficial app features and intervention components and call for consistent and comprehensive intervention and outcome reporting.