A Randomized Controlled Trial to Evaluate the Effects of a Smartphone Application-Based Lifestyle Coaching Program on Gestational Weight Gain, Glycemic Control, and Maternal and Neonatal Outcomes in Women With Gestational Diabetes Mellitus: The SMART-GDM Study.
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ABSTRACT: Objective
SMART-GDM examined whether Habits-GDM, a smartphone application (app) coaching program, can prevent excessive gestational weight gain (EGWG) and improve glycemic control and maternal and neonatal outcomes in gestational diabetes mellitus (GDM).Research design and methods
In this randomized controlled trial, women diagnosed with GDM between 12 and 30 weeks were randomly assigned to usual care (control) or to additional support from Habits-GDM that integrated dietary, physical activity, weight, and glucose monitoring (intervention). The primary outcome was the proportion of participants with EGWG. Secondary outcomes included absolute gestational weight gain (GWG), glycemic control, and maternal, delivery, and neonatal outcomes.Results
In total, 340 women were randomized (170 intervention, 170 control; mean ± SD age 32.0 ± 4.2 years; mean BMI 25.6 ± 5.6 kg/m2). There were no statistically significant differences in the proportions of women with EGWG, absolute GWG, or maternal and delivery outcomes between experimental groups. Average glucose readings were lower in the intervention group (mean difference -0.15 mmol/L [95% CI -0.26; -0.03], P = 0.011) as were the proportions of glucose above targets (premeal: 17.9% vs. 23.3%, odds ratio 0.68 [95% CI 0.53; 0.87], P = 0.003; 2-h postmeal: 19.9% vs. 50%, 0.54 [0.42; 0.70], P < 0.001). When regarded as a composite (although not prespecified), the overall neonatal complications (including birth trauma, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress, neonatal intensive care unit admission, and perinatal death) were significantly lower in the intervention group (38.1% vs. 53.7%, 0.53 [0.34; 0.84], P = 0.006).Conclusions
When added to usual care, Habits-GDM resulted in better maternal glycemic control and composite neonatal outcomes (nonprespecified) but did not reduce EGWG among women with GDM.
SUBMITTER: Yew TW
PROVIDER: S-EPMC7818327 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo examine the association of maternal pre-pregnancy body mass index (BMI) and gestational weight gain (GWG) with anthropometry in the offspring of mothers with gestational diabetes mellitus (GDM).MethodsWe performed a retrospective cohort study in 1263 GDM mother-child pairs. General linear models and Logistic regression models were used to assess the single and joint associations of maternal pre-pregnancy BMI (normal weight, overweight, and obesity) and GWG (inadequate, adequate and excessive GWG) with anthropometry and overweight status in the offspring from birth to 1-5 years old.ResultsMaternal pre-pregnancy BMI and GWG were positively associated with birth weight for gestational age Z score and birth weight for length for gestational age Z score at birth, and weight for age Z score, length/height for age Z score, and weight for length/height Z score at of 1-5 years old offspring. Maternal pre-pregnancy overweight, obesity, and excessive GWG were associated with increased risks of large for gestational age [ORs 95% CIs = 1.87 (1.37-2.55), 2.98 (1.89-4.69), and 2.93 (2.07-4.13), respectively] and macrosomia [ORs 95% CIs = 2.06 (1.50-2.84), 2.89 (1.78-4.70), and 2.84 (1.98-4.06), respectively] at birth and childhood overweight at 1-5 years old [ORs 95% CIs = 1.26 (0.92-1.73), 1.96 (1.24-3.09), and 1.59 (1.15-2.21), respectively].ConclusionsOffspring born to GDM mothers with pre-pregnancy overweight/obesity or excessive GWG were associated with increased risks of large for gestational age and macrosomia at birth, and childhood overweight at 1-5 years old, compared with those born to GDM mothers with pre-pregnancy normal weight and adequate GWG.
| S-EPMC4476720 | biostudies-literature
Project description:BACKGROUND:Traditional dietary recommendations for achieving optimal gestational weight gain are ineffective for pregnant women due to the lack of real-time communication and tedious consultation processes. OBJECTIVE:In this pilot study, we aimed to determine the feasibility of a novel food-coaching smartphone app for controlling gestational weight gain and macronutrient intake among overweight and obese pregnant women. METHODS:We designed a randomized controlled trial and recruited 30 overweight and obese pregnant women (1:1 ratio) during 18-20 weeks of gestation and followed them up after 4 and 8 weeks, respectively. Both groups received standard pregnancy dietary orientation at recruitment, while the intervention group received 8 weeks of real-time food coaching via a smartphone app. This food-coaching smartphone app (Glycoleap, Holmusk, Singapore) aimed to improve care and outcomes for people with diabetes. Pregnant women using this app were able to upload food images (eg, a picture of a meal, a drink, or a dessert) and received real-time and detailed food-coaching comments and guidance provided by professional dietitians during the day (8 AM to 8 PM). We recorded detailed characteristics during recruitment and examined anthropometry at all visits. We compared the mean differences of the 8-week gestational weight gain and macronutrient intake between the two groups. RESULTS:Upon study completion, three subjects dropped out from the intervention, and one gave birth prematurely in the control group. The acceptance rate of the smartphone app was 90%. More participants achieved optimal gestational weight gain per week in the intervention group (8/12, 67%) than in the control group (5/14, 36%). After the 8-week intervention, women in the intervention group appeared to have lower gestational weight gain (mean difference=-0.08 kg; 95% CI -1.80 to 1.63) and cholesterol intake (mean difference=-31.73 mg; 95% CI -102.91 to 39.45) than those in the control group. CONCLUSIONS:Our findings showed that this food-coaching smartphone app is feasible and favorable for weight gain control and cholesterol intake control among overweight and obese pregnant women. Although our results were not significant (perhaps, attributed to the small sample size), it provided proof of concept for the feasibility of applying such technology in future randomized controlled trials with a larger sample size, an earlier intervention onset, and a longer follow-up for overweight and obese pregnant women.
| S-EPMC6914273 | 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:Context:Disturbed circadian rhythms and sleep quality during pregnancy have been related to gestational weight gain and gestational diabetes mellitus (GDM), which affect postpartum glucose metabolism and future risk of type 2 diabetes. Objective:We assessed whether the circadian rhythm-related melatonin receptor 1B (MTNR1B) genotype was associated with 1 to 5 years of postpartum glycemic changes among women with a history of GDM and whether gestational weight gain modified such associations. Design, Settings, and Participants:The established circadian rhythm-associated MTNR1B genetic variant (rs10830963) was genotyped in 1025 Chinese women with a history of GDM. Body weight and glycemic traits, during and after pregnancy, were longitudinally collected. Main Outcome Measures:The main outcome measure was postpartum glycemic changes. Results:We found that women carrying different MTNR1B genotypes showed distinct postpartum changes in 2-hour oral glucose tolerance test: 0.36, 0.20, and -0.19 mM per additional copy of the shorter sleep duration-related G allele in women with inadequate, adequate, and excessive gestational weight gain, respectively (for interaction, P = 0.028). The corresponding changes in fasting glucose were 0.14, 0.13, and 0.01 mM, although the modification effect of gestational weight gain on the genetic association was marginally significant (for interaction, P = 0.067). Conclusions:Our findings suggest that gestational weight gain may modify the circadian rhythm-related MTNR1B genetic variant on long-term glycemic changes, highlighting the significance of gestational weight management in diabetes prevention among women with GDM.
| S-EPMC6276711 | biostudies-literature
Project description:Maternal nutritional and metabolic status influence fetal growth. This study investigated the contribution of gestational weight gain (GWG), gestational diabetes (GDM), and maternal obesity to birthweight and newborn body fat. It is a secondary analysis of a prospective study including 204 women with a pregestational body mass index (BMI) of 18.5-24.9 kg/m2 and 219 women with BMI ≥ 30 kg/m2. GDM was screened in the second and third trimester and was treated by dietary intervention, and insulin if required. Maternal obesity had the greatest effect on skinfolds (+1.4 mm) and cord leptin (+3.5 ng/mL), but no effect on birthweight. GWG was associated with increased birthweight and skinfolds thickness, independently from GDM and maternal obesity. There was an interaction between third trimester weight gain and GDM on birthweight and cord leptin, but not with maternal obesity. On average, +1 kg in third trimester was associated with +13 g in birthweight and with +0.64 ng/mL in cord leptin, and a further 32 g and 0.89 ng/mL increase in diabetic mothers, respectively. Maternal obesity is the main contributor to neonatal body fat. There is an independent association between third trimester weight gain, birthweight, and neonatal body fat, enhanced by GDM despite intensive treatment.
| S-EPMC7698189 | biostudies-literature
Project description:AimsWomen with prior gestational diabetes mellitus (GDM) or high genetic susceptibility are prone to development of type 2 diabetes. We examined whether a lifestyle intervention modified the genetic effect on changes in glycemic markers among women with prior GDM.Research design and methodsThis study included 560 women with prior GDM from a randomized controlled trial, the Tianjin Gestational Diabetes Mellitus Prevention Program, who were assigned into an intervention arm (improved physical activity and healthy dietary intakes) or a control arm. We assessed associations of GDM related genetic variants in/near the CDKAL1 (rs7754840) and MTNR1B (rs10830962) genes with changes in fasting levels of glucose and insulin, β-cell function (HOMA-B) and insulin resistance (HOMA-IR) at 1 year and 2 years after the baseline.ResultsWe found significant interactions between CDKAL1 variant rs7754840 and lifestyle intervention on changes in fasting insulin and HOMA-IR at 1 year (P for interactions = 0.008 and 0.006, respectively). The GDM-increasing C allele was associated with a 0.07-unit greater increase in fasting insulin (P = 0.048) and HOMA-IR (P = 0.045) in the control group, while opposite-directional associations were observed in the intervention group; women with the C allele seemed to decrease more in these glycemic markers than the non-C-carriers (both P ≤ 0.06). The interactions between the CDKAL1 genetic variant and lifestyle intervention on changes in fasting insulin (P = 0.035) and HOMA-IR (P = 0.024) remained significant over the 2-year period, even though the effects of lifestyle intervention were attenuated at 2-year. The MTNR1B variant rs10830962 did not show interaction with lifestyle intervention on changes in the glycemic markers.ConclusionsHealthy lifestyle intervention may be beneficial for women with the GDM predisposing CDKAL1 genetic variant in improvement of insulin resistance.Trial registration numberClinicalTrials.gov NCT01554358. URL OF REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01554358.
| S-EPMC7062571 | biostudies-literature
Project description:IntroductionGestational weight gain (GWG) and postpartum weight retention (PPWR) are significant, potentially modifiable, contributors to women's future weight and health trajectories. There is a need for feasible and patient-centered (i.e., convenient, remotely-delivered, technology-enhanced, and accessible through the prenatal care setting) behavioural interventions that limit GWG and PPWR. This study tests the feasibility and acceptability of a remotely-delivered behavioural health coaching intervention to limit gestational weight gain and postpartum weight retention.MethodsPregnant women (11-16 weeks gestation) were recruited from two prenatal clinics and randomized to the active intervention or health education comparison group. Completion of the program was monitored and perceived helpfulness was rated (0-100).ResultsTwenty-six women were randomized (n = 13 per arm; mean age = 31.6 years, SD = 3.6; mean BMI = 26.7 kg/m2, SD = 7.4). Participants completed a median of 18 coaching calls and 16/19 learning activities during pregnancy, and a median of 6 calls and 5/6 learning activities postpartum. They logged weights at least once/week for a median of 36/38 expected weeks and tracked daily calories and exercise for a median of 154/266 days and 72/266 days, respectively. Median (Q1, Q3) helpfulness ratings of the program during pregnancy were 80 (64, 91) and 62 (50, 81) postpartum; helpfulness ratings of coaching calls were 85 (58, 98). At 37 weeks gestation, 77% of participants achieved IOM weight gain recommendations compared to 54% in the comparison group.ConclusionsThis study provides evidence for the feasibility and acceptability of a remotely-delivered behavioural weight control intervention in pregnancy and postpartum.
| S-EPMC7556432 | biostudies-literature
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.
| S-EPMC10674147 | biostudies-literature
Project description:ObjectiveTo evaluate the relationships among excessive gestational weight gain, neonatal adiposity, and adverse obstetric outcomes in women with mild gestational diabetes mellitus.MethodsThis is a secondary analysis of a multicenter randomized clinical trial of women with mild gestational diabetes mellitus. Based on self-reported prepregnancy body weight, gestational weight gain was categorized as excessive if it was greater than 2009 Institute of Medicine guidelines. Maternal outcomes and neonatal anthropomorphic characteristics were compared between women with excessive weight gain and those without excessive weight gain. Multiple linear and logistic regression analyses were performed to adjust for confounding factors.ResultsWe studied 841 women who participated in the main trial and had prepregnancy body mass index (BMI) and delivery information available (n=431 treatment group, n=410 no treatment). After adjustment for factors including treatment and prepregnancy BMI, excessive weight gain remained associated with large for gestational age (adjusted odds ratio [OR] 2.94, 95% confidence interval [CI] 1.81-4.93), birth weight greater than 4,000 g (adjusted OR 2.56, 95% CI 1.54-4.40), preeclampsia (adjusted OR 2.96, 95% CI 1.35-7.03), and cesarean delivery for labor arrest (adjusted OR 2.37, 95% CI 1.30-4.44). In addition, excessive weight gain was independently associated with increased total neonatal fat (P<.001) and birth weight (P<.001).ConclusionIn women with both treated and untreated mild gestational diabetes mellitus, excessive gestational weight gain was independently associated with both greater birth weight and adiposity.
| S-EPMC5123848 | biostudies-literature
Project description:BackgroundMetabolic disorders are established precursors to cardiovascular diseases, yet they can be readily prevented with sustained lifestyle modifications.ObjectiveWe assessed the effectiveness of a smartphone-based weight management app on metabolic parameters in adults at high-risk, yet without physician diagnosis nor pharmacological treatment for metabolic syndrome, in a community setting.MethodsIn this 3-arm parallel-group, single-blind, randomized controlled trial, we recruited participants aged 30 to 59 years with at least 2 conditions defined by the Third Report of the National Cholesterol Education Program expert panel (abdominal obesity, high blood pressure, high triglycerides, low high-density lipoprotein cholesterol, and high fasting glucose level). Participants were randomly assigned (1:1:1) by block randomization to either the nonuser group (control), the app-based diet and exercise self-logging group (app only), or the app-based self-logging and personalized coaching from professional dieticians and exercise coordinators group (app with personalized coaching). Assessments were performed at baseline, week 6, week 12, and week 24. The primary outcome was change in systolic blood pressure (between baseline and follow-up assessments). Secondary outcomes were changes in diastolic blood pressure, body weight, body fat mass, waist circumference, homeostatic model of assessment of insulin resistance, triglyceride level, and high-density lipoprotein cholesterol level between baseline and follow-up assessments. Analysis was performed using intention-to-treat.ResultsBetween October 28, 2017 and May 28, 2018, 160 participants participated in the baseline screening examination. Participants (129/160, 80.6%) who satisfied the eligibility criteria were assigned to control (n=41), app only (n=45), or app with personalized coaching (n=43) group. In each group, systolic blood pressure showed decreasing trends from baseline (control: mean -10.95, SD 2.09 mmHg; app only: mean -7.29, SD 1.83 mmHg; app with personalized coaching: mean -7.19, SD 1.66 mmHg), yet without significant difference among the groups (app only: P=.19; app with personalized coaching: P=.16). Instead, those in the app with personalized coaching group had greater body weight reductions (control: mean -0.12, SD 0.30 kg; app only: mean -0.35, SD 0.36 kg, P=.67; app with personalized coaching: mean -0.96, SD 0.37 kg; P=.08), specifically by body fat mass reduction (control: mean -0.13, SD 0.34 kg; app only: mean -0.64, SD 0.38 kg, P=.22; app with personalized coaching: mean -0.79, SD 0.38 kg; P=.08).ConclusionsSimultaneous diet and exercise self-logging and persistent lifestyle modification coaching were ineffective in lowering systolic blood pressure but effective in losing weight and reducing body fat mass. These results warrant future implementation studies of similar models of care on a broader scale in the context of primary prevention.Trial registrationClinicalTrials.gov NCT03300271; http://clinicaltrials.gov/ct2/show/NCT03300271.
| S-EPMC7584978 | biostudies-literature