A Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Protocol for a Randomized Controlled Trial.
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ABSTRACT:
SUBMITTER: Henriksson P
PROVIDER: S-EPMC6418485 | biostudies-literature | 2019 Mar
REPOSITORIES: biostudies-literature
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A Smartphone App to Promote Healthy Weight Gain, Diet, and Physical Activity During Pregnancy (HealthyMoms): Protocol for a Randomized Controlled Trial.
Henriksson Pontus P Sandborg Johanna J Blomberg Marie M Alexandrou Christina C Maddison Ralph R Silfvernagel Kristin K Henriksson Hanna H Leppänen Marja H MH Migueles Jairo H JH Widman Linnea L Thomas Kristin K Trolle Lagerros Ylva Y Löf Marie M
JMIR research protocols 20190301 3
<h4>Background</h4>Excessive gestational weight gain is common and associated with adverse outcomes both in the short and long term. Although traditional lifestyle-based interventions have shown to mitigate excess gestational weight gain, little is known about whether mobile Health (mHealth) apps can promote healthy weight gain, diet, and physical activity during pregnancy.<h4>Objective</h4>The primary aim of the HealthyMoms trial is to determine the effectiveness of a smartphone app (HealthyMom ...[more]
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Project description:BackgroundExcessive 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.ObjectiveTo 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.MethodsA 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.ResultsOverall, 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).ConclusionsAlthough 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 registrationClinicalTrials.gov NCT03298555; https://clinicaltrials.gov/ct2/show/NCT03298555.International registered report identifier (irrid)RR2-10.2196/13011.
| S-EPMC7995071 | biostudies-literature
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.
| S-EPMC7980113 | biostudies-literature
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.
| S-EPMC6000478 | biostudies-other
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.
| S-EPMC7413979 | biostudies-literature
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.
| S-EPMC9942425 | biostudies-literature
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.
| S-EPMC10020902 | biostudies-literature
Project description:ImportanceExcessive gestational weight gain (GWG) is common and associated with adverse pregnancy outcomes. Antenatal lifestyle interventions limit GWG; yet benefits of different intervention types and specific maternal and neonatal outcomes are unclear.ObjectiveTo evaluate the association of different types of diet and physical activity-based antenatal lifestyle interventions with GWG and maternal and neonatal outcomes.Data sourcesA 2-stage systematic literature search of MEDLINE, Embase, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, and Health Technology Assessment Database was conducted from February 1, 2017, to May 31, 2020. Search results from the present study were integrated with those from a previous systematic review from 1990 to February 2017.Study selectionRandomized trials reporting GWG and maternal and neonatal outcomes.Data extraction and synthesisData were extracted for random-effects meta-analyses to calculate the summary effect estimates and 95% CIs.Main outcomes and measuresOutcomes were clinically prioritized, with mean GWG as the primary outcome. Secondary outcomes included gestational diabetes, hypertensive disorders of pregnancy, cesarean section, preterm delivery, large or small for gestational age neonates, neonatal intensive care unit admission, or fetal death.ResultsA total of 117 randomized clinical trials of antenatal lifestyle interventions (involving 34 546 women) were included. Overall lifestyle intervention was associated with reduced GWG (-1.15 kg; 95% CI, -1.40 to -0.91), risk of gestational diabetes (odds ratio [OR], 0.79; 95% CI, 0.70-0.89), and total adverse maternal outcomes (OR, 0.89; 95% CI, 0.84-0.94) vs routine care. Compared with routine care, diet was associated with less GWG (-2.63 kg; 95% CI, -3.87 to -1.40) than physical activity (-1.04 kg; 95% CI, -1.33 to -0.74) or mixed interventions (eg, unstructured lifestyle support, written information with weight monitoring, or behavioral support alone) (-0.74 kg; 95% CI, -1.06 to -0.43). Diet was associated with reduced risk of gestational diabetes (OR, 0.61; 95% CI, 0.45-0.82), preterm delivery (OR, 0.43; 95% CI, 0.22-0.84), large for gestational age neonate (OR, 0.19; 95% CI, 0.08-0.47), neonatal intensive care admission (OR, 0.68; 95% CI, 0.48-0.95), and total adverse maternal (OR, 0.75; 95% CI, 0.61-0.92) and neonatal outcomes (OR, 0.44; 95% CI, 0.26-0.72). Physical activity was associated with reduced GWG and reduced risk of gestational diabetes (OR, 0.60; 95% CI, 0.47-0.75), hypertensive disorders (OR, 0.66; 95% CI, 0.48-0.90), cesarean section (OR, 0.85; 95% CI, 0.75-0.95), and total adverse maternal outcomes (OR, 0.78; 95% CI, 0.71-0.86). Diet with physical activity was associated with reduced GWG (-1.35 kg; 95% CI, -1.95 to -0.75) and reduced risk of gestational diabetes (OR, 0.72; 95% CI, 0.54-0.96) and total adverse maternal outcomes (OR, 0.81; 95% CI, 0.69-0.95). Mixed interventions were associated with reduced GWG only.Conclusions and relevanceThis systematic review and meta-analysis found level 1 evidence that antenatal structured diet and physical activity-based lifestyle interventions were associated with reduced GWG and lower risk of adverse maternal and neonatal outcomes. The findings support the implementation of such interventions in routine antenatal care and policy around the world.
| S-EPMC8689430 | biostudies-literature
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.
| S-EPMC7687729 | biostudies-literature
Project description:During aging, blood cell production becomes dominated by a limited number of variant hematopoietic stem cell (HSC) clones. Differentiated progeny of variant HSCs are thought to mediate the detrimental effects of such clonal hematopoiesis on organismal health, but the mechanisms are poorly understood. While somatic mutations in DNA methyltransferase 3A (DNMT3A) frequently drive clonal dominance, the aging milieu also likely contributes. Here, we examined in mice the interaction between high-fat diet (HFD) and reduced DNMT3A in hematopoietic cells; strikingly, this combination led to weight gain. HFD amplified pro-inflammatory pathways and upregulated inflammation-associated genes in mutant cells along a pro-myeloid trajectory. Aberrant DNA methylation during myeloid differentiation and in response to HFD led to pro-inflammatory activation and maintenance of stemness genes. These findings suggest that reduced DNMT3A in hematopoietic cells contributes to weight gain, inflammation, and metabolic dysfunction, highlighting a role for DNMT3A loss in the development of metabolic disorders.
| S-EPMC10897855 | biostudies-literature
Project description:BackgroundThe issue of low physical activity (PA) levels among the youth is a longstanding concern. Smartphone applications offer a promising avenue for delivering interventions that are both accessible and engaging. Up to now, there appears to be a gap in the literature, with no systematic reviews assessing the efficacy of smartphone apps in encouraging increased physical activity among healthy young adults.ObjectiveTo synthesize the effects of a smartphone app-based intervention on PA and PA-related psychological correlates in healthy young adults (18-35 years old).MethodsA search was conducted on eighteen databases: PubMed, Medline, Web of Science, SPORTDiscus, Scopus, Academic Search Premier, Communication and Mass Media Complete, Article First, Biomed Central, BioOne, EBSCOHost, JSTOR, ProQuest, SAGE Reference Online, ScienceDirect, SpringerLink, Taylor&Francis, and Wiley Online. The search covered the period up until December 2023. This research included all randomized controlled trials (RCTs) that evaluated the effectiveness of smartphone app-based interventions on PA and PA related psychological outcomes in healthy young adults. The overall impact was determined by vote counting based on the direction of effect and aggregating p values. The quality of the evidence was evaluated using an 8-item scale. This study has been registered in the PROSPERO database with the identification number CRD42023390033.ResultsA total of 8403 articles were retrieved, and based on the predefined inclusion and exclusion criteria, seven articles were selected for inclusion. Among these articles, four high-quality RCTs were identified, and the results of vote counting and combining p values methods suggested that smartphone-based app interventions did not demonstrate significant effectiveness in improving PA and PA-related psychological outcomes. However, some improvements were observed. The analysis results, which were categorized into fitness apps and health apps based on the characteristics of the interventions, also failed to demonstrate significant intervention effects.ConclusionThe findings indicate that, currently, there are no significant effects of smartphone app interventions on improving PA and PA-related psychological outcomes in healthy young adults aged 18-35 years. It is important to note that these findings should be interpreted with caution due to the limited number of included studies. Future research should focus on employing high-quality study designs to determine the true effects of interventions and analyze various smartphone app interventions. These analyses should encompass different app characteristics (e.g., fitness app and health app), various combinations (e.g., fitness app alone and fitness app in combination with other interventions), diverse intervention goals (e.g., PA and PA along with other outcomes), and multiple intervention characteristics (e.g., frequency and duration).
| S-EPMC10997080 | biostudies-literature