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Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial.

ABSTRACT: BACKGROUND:Two-thirds of pregnant women exceed gestational weight gain (GWG) recommendations. Because excess GWG is associated with adverse outcomes for mother and child, development of scalable and cost-effective approaches to deliver intensive lifestyle programs during pregnancy is urgent. OBJECTIVE:The aim of this study was to decrease the proportion of women who exceed the Institute of Medicine (IOM) 2009 GWG guidelines. METHODS:In a parallel-arm randomized controlled trial, 54 pregnant women (age 18-40 years) who were overweight (n=25) or obese (n=29) were enrolled to test whether an intensive lifestyle intervention (called SmartMoms) decreased the proportion of women with excess GWG, defined as exceeding the 2009 IOM guidelines, compared to no intervention (usual care group). The SmartMoms intervention was delivered through mobile phone (remote group) or in a traditional in-person, clinic-based setting (in-person group), and included a personalized dietary intake prescription, self-monitoring weight against a personalized weight graph, activity tracking with a pedometer, receipt of health information, and continuous personalized feedback from counselors. RESULTS:A significantly smaller proportion of women exceeded the IOM 2009 GWG guidelines in the SmartMoms intervention groups (in-person: 56%, 10/18; remote: 58%, 11/19) compared to usual care (85%, 11/13; P=.02). The remote intervention was a lower cost to participants (mean US $97, SD $6 vs mean US $347, SD $40 per participant; P<.001) and clinics (US $215 vs US $419 per participant) and with increased intervention adherence (76.5% vs 60.8%; P=.049). CONCLUSIONS:An intensive lifestyle intervention for GWG can be effectively delivered via a mobile phone, which is both cost-effective and scalable. TRIAL REGISTRATION:Clinicaltrials.gov NCT01610752; https://clinicaltrials.gov/ct2/show/NCT01610752 (Archived by WebCite at http://www.webcitation.org/6sarNB4iW).

SUBMITTER: Redman LM

PROVIDER: S-EPMC5617906 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial.

Redman Leanne M LM Gilmore L Anne LA Breaux Jeffrey J Thomas Diana M DM Elkind-Hirsch Karen K Stewart Tiffany T Hsia Daniel S DS Burton Jeffrey J Apolzan John W JW Cain Loren E LE Altazan Abby D AD Ragusa Shelly S Brady Heather H Davis Allison A Tilford J Mick JM Sutton Elizabeth F EF Martin Corby K CK

JMIR mHealth and uHealth 20170913 9

<h4>Background</h4>Two-thirds of pregnant women exceed gestational weight gain (GWG) recommendations. Because excess GWG is associated with adverse outcomes for mother and child, development of scalable and cost-effective approaches to deliver intensive lifestyle programs during pregnancy is urgent.<h4>Objective</h4>The aim of this study was to decrease the proportion of women who exceed the Institute of Medicine (IOM) 2009 GWG guidelines.<h4>Methods</h4>In a parallel-arm randomized controlled t ...[more]

PMID: 28903892

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Project description:It is unclear whether weight management is still effective for pregnant women with excessive weight gain in the second or third trimester in China. This study adopted individualized weight management intervention for pregnant women with abnormal weight gain in the second or third trimester, to analyze the effect of intervention by observing the gestational weight gain and perinatal outcomes. This randomized controlled trial was performed at Aerospace Center Hospital. The obstetrician determined whether the pregnant women gained too much weight in the second or third trimester according to the Institute of Medicine guidelines, and randomly divided the pregnant women who gained too much weight in the second or third trimester into the intervention group or the control group according to the inclusion and exclusion criteria. The pregnant women in the intervention group and in the control group all received routine prenatal examination and diet nutrition education by the doctors in the Department of Obstetrics and Gynecology. The intervention group underwent individualized weight management, including individualized diet, exercise, psychological assessment, cognitive intervention and continuous communication, the whole process is tracked and managed by professional nutritionists. The obstetrician collected the prenatal examination data and pregnancy outcome data of all enrolled pregnant women. The primary outcome measure was weight gain during pregnancy. A generalized linear model and a logistic regression model were used to compare the outcomes between the two groups. In total, 348 pregnant women participated in this study with 203 in the intervention group and 145 in the control group. The whole gestational weight gain in the intervention group (15.8 ± 5.4 Kg) was lower than that in the control group (17.5 ± 3.6 Kg; adjusted β = - 1.644; 95% CI [-2.660--0.627]; P = 0.002). The percent of pregnant women with excessive weight gainbefore delivery was 54.2% (110/203) in the intervention group, which was lower than 69.7% (101/145) in the control group (adjusted RR = 0.468; 95% CI [0.284-0.769] P = 0.003). The pregnant women given the individualized weight management intervention from the second to the third trimester experienced less weight gain than that from the third trimester (15.5 ± 5.6 Kg vs. 16.2 ± 5.2 Kg), but without significant difference (P = 0.338). Lower rates of GDM, preeclampsia and gestational hypertension, higher rates of fetal distress and puerperal infection were observed in the intervention group than in the control group (all P < 0.05). Individualized weight management during the second or third trimesters is still beneficial for pregnant women who gain excessive weight and can decrease the associated adverse outcomes.

Project description:BACKGROUND:Excessive gestational weight gain (GWG) contributes to the development of obesity in mother and child. Internet-based interventions have the potential for delivering innovative and interactive options for prevention of excessive GWG to large numbers of people. OBJECTIVE:The objective of this study was to create a novel measure of Internet-based intervention usage patterns and examine whether usage of an Internet-based intervention is associated with reduced risk of excessive GWG. METHODS:The website featured blogs, local resources, articles, frequently asked questions (FAQs), and events that were available to women in both the intervention and control arm. Weekly reminders to use the website and to highlight new content were emailed to participants in both arms. Only intervention arm participants had access to the weight gain tracker and diet and physical activity goal-setting tools. A total of 1335 (898 intervention and 437 control) relatively diverse and healthy pregnant women were randomly assigned to the intervention arm or control arm. Usage patterns were examined for both intervention and control arm participants using latent class analysis. Regression analyses were used to estimate the association between usage patterns and three GWG outcomes: excessive total GWG, excessive GWG rate, and GWG. RESULTS:Five usage patterns best characterized the usage of the intervention by intervention arm participants. Three usage patterns best characterized control arm participants' usage. Control arm usage patterns were not associated with excessive GWG, whereas intervention arm usage patterns were associated with excessive GWG. CONCLUSIONS:The control and intervention arm usage pattern characterization is a unique methodological contribution to process evaluations for self-directed Internet-based interventions. In the intervention arm some usage patterns were associated with GWG outcomes. CLINICALTRIAL:ClinicalTrials.gov; Clinical Trials Number: NCT01331564; https://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation/6nI9LuX9w).

Project description:BackgroundExcessive gestational weight gain (GWG) is common and contributes to the development of obesity in women and their offspring. Electronic or e-health interventions have the potential to reach large groups of women and prevent excessive GWG, but their effectiveness has not been demonstrated. The purpose of this study was to evaluate, in a real-world setting, the effectiveness of a self-directed, integrated online and mobile phone behavioral intervention in preventing excessive GWG.MethodsThis effectiveness trial was a double-blind, three-arm trial with a parallel group design. Two arms received the same e-health intervention during pregnancy with the third arm serving as the placebo control. The intervention was based on a previously efficacious non-digital intervention that was adapted to electronic format. It included three behavior change tools: a weight gain tracker, and separate diet and physical activity goal-setting and self-monitoring tools. Both treatment conditions received access to informational tools, event reminders, and a blogging feature. Healthy pregnant women age 18-35 years with body mass indexes (BMI) ≥18.5 and < 35, at ≤20 weeks gestation, and an e-mail address were eligible. The proportion of women with excessive total GWG, as defined by the Institute of Medicine (IOM), was the primary outcome. 1689 randomized women were analyzed in the intent-to-treat (ITT) analysis. The study was designed to have 87% power to detect a 10 percentage point reduction from a control rate of 55% with a sample of 1641 (p = 0.0167, two-sided).ResultsIn the ITT sample, 48.1% (SD = 2.0%) gained excessively in the intervention group as did 46.2% (SD = 2.4%) in the placebo control group. These proportions were not significantly different (RR 1.09; 95% CI 0.98, 1.20, p = 0.12). The results were not altered in several sensitivity analyses.ConclusionThe addition of three behavior change tools to an informational placebo control did not result in a difference in the proportion of women with excessive total GWG compared to the placebo control in this effectiveness trial of an online, self-directed intervention. The similarity of intervention and control treatments and low usage of the behavior change tools in the intervention group are possible explanations.Trial registrationNCT01331564 , ClinicalTrials.gov.

Project description:Background:Behavioral lifestyle interventions during pregnancy can prevent excessive gestational weight gain (GWG) in women with normal weight; however, effective interventions to reduce GWG in ethnically diverse women with obesity are lacking. Objective:A randomized controlled trial was conducted to test whether a behavioral lifestyle intervention with partial meal replacement reduces GWG rate in Hispanic and non-Hispanic women with overweight or obesity relative to enhanced usual care. Design:Participants (n = 257) were recruited in San Luis Obispo, California, and Providence, Rhode Island, between November 2012 and May 2016. Participants were pregnant (mean ± SD: 13.6 ± 1.8 wk of gestation) with overweight or obesity and had a mean age of 30.3 y; 41.6% of participants were Hispanic. Women were randomly assigned within site and by ethnicity to enhanced usual care (n = 128) or to a behavioral lifestyle intervention with partial meal replacement (n = 129). The primary outcome was GWG per week of observation. Secondary outcomes were proportions exceeding Institute of Medicine (IOM) guidelines for total GWG, changes in weight-control behaviors and cardiovascular disease risk factors, and incidence of pregnancy complications. Study retention was 99.6% (256 of 257). Results:The intervention compared with usual care resulted in less mean ± SD weekly GWG (0.33 ± 0.25 compared with 0.39 ± 0.23 kg/wk; P = 0.02) and total GWG (9.4 ± 6.9 compared with 11.2 ± 7.0 kg; P = 0.03) and reduced the proportion of women who exceeded IOM guidelines for total GWG (41.1% compared with 53.9%; P = 0.03). No significant group × time × demographic subgroup (ethnicity, BMI, age, parity, and income) interactions were observed. Among intervention participants, greater meal replacement intake was related to reduced GWG rate (? = -0.07; 95% CI:-0.12, -0.03; P = 0.002). The intervention compared with usual care increased weight-control strategies (P < 0.0001) and cognitive restraint (P < 0.0001) and reduced triglycerides (P = 0.03). Conclusion:Prenatal behavioral intervention with partial meal replacement significantly reduced GWG in Hispanic and non-Hispanic women with overweight or obesity. This trial was registered at www.clinicaltrials.gov as NCT01545934.

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:OBJECTIVES:To assess feasibility/acceptability of a mindfulness-based approach to excess weight prevention in adolescents at-risk for excess weight gain. To pilot test efficacy of a mindfulness-based intervention for improving food reward sensitivity, stress-eating, executive function (EF), and BMI/adiposity. METHODS:A pilot randomized controlled trial was conducted with 12-17y adolescents at-risk for excess weight gain based on above-average weight (body mass index [BMI]?70%ile) or parental history of obesity (BMI?30?kg/m2). Adolescents were randomized to a mindfulness-based (n?=?29) or health education control group (n?=?25) that met for six weekly one-hour sessions. Feasibility/acceptability were determined from attendance and acceptability survey ratings. At baseline, six-week and six-month follow-up, adolescents' perceived stress was measured with the Perceived Stress Scale, food reward sensitivity with a behavioral task, stress-eating during a laboratory test meal, and EF with the parent-reported Behavior Rating Inventory of Executive Function and NIH Toolbox. At the same intervals, BMI indices and body fat by air displacement plethysmography were assessed in a fasted state. RESULTS:Median session attendance was 6:6 sessions in both conditions; program acceptability ratings were above-average. Compared to health education, adolescents in mindfulness had lower food reward sensitivity at six-months (Cohen's d?=?0.64, p?=?.01). There were no between-condition differences in BMI (mindfulness vs. health education?six-months 95%CI 0.20, 1.52?kg/m2 vs. 0.21, 1.62?kg/m2) or adiposity (-3.64, -0.61% vs. -4.31, -1.04%) changes. CONCLUSIONS:A mindfulness-based group intervention is feasible/acceptable among adolescents at-risk for excess weight. In this pilot sample, mindfulness and health education were equivocal for BMI/adiposity outcomes. Future trials with a larger, adequately-powered sample and longer-term follow-up are necessary to test efficacy of a mindfulness-based intervention for food reward sensitivity, stress-eating, EF, and stabilizing growth trajectories in youth at-risk for adult obesity.

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.

Project description:Trial designExcessive gestational weight gain (GWG) can increase pregnancy morbidity and is particularly problematic for women with pregestational obesity. A lifestyle modification intervention was introduced to gravida with obesity to decrease excessive GWG as compared to usual care (UC).MethodsA randomized controlled trial was conducted to improve healthy lifestyle behaviors to manage appropriate GWG. Consenting participants with prepregnancy obesity and singletons ≤17 weeks were randomized to (1) Usual Care (UC): usual written educational materials and counseling by obstetric provider or (2) Enhanced Care (EC): UC plus (a) personalized letter from physician detailing appropriate GWG; (b) access to individualized GWG chart; (c) ongoing counseling with registered dietitian/nutritionist (RDN). The primary outcome was proportion with GWG ≤9.1 kg, as this is upper limit recommended by Institute of Medicine (IOM). Total GWG and GWG as less than/within/greater than IOM recommendations (in aggregate and stratified by obesity class), and pregnancy/neonatal outcomes were evaluated as secondary outcomes.ResultsAnalyses included 105 participants in EC and 109 in UC arms. The groups had similar demographics: 46% with class I obesity, 26% class II, and 28% class III. There were no group differences for any GWG, pregnancy, or neonatal outcomes when analyzed in aggregate. As compared to those randomized to the EC arm, participants in UC arm with class I obesity gained 1.4 kg less and those with class II obesity were significantly more likely to gain within IOM guidelines (14.8% vs. 40.0%, adjusted p = 0.04). Participants with class III obesity randomized to EC arm were more likely to gain within IOM guidelines as compared to participants randomized to UC arm (29.0% vs. 6.7%, adjusted p = 0.02).ConclusionThere were no differences in GWG observed between groups when analyzing participants in aggregate. However, a physician's letter detailing appropriate GWG, patient portal access to a personalized GWG chart, and RDN consultation were helpful for encouraging GWG within IOM guidelines for women with prepregnancy class III obesity. Women with class I or II obesity had better GWG outcomes without these additional interventions.

Project description:Online interventions have emerged as a popular strategy to promote healthy behaviors. Currently, there is little agreement about how to capture online intervention engagement. It is also uncertain who engages with weight-related online interventions and how engagement differs by demographic and weight characteristics.The objectives of this study were to (1) characterize how pregnant women engaged with features of an online intervention to prevent excessive gestational weight gain, (2) identify demographic and weight status subgroups of women within the sample, and (3) examine differences in use of intervention features across the demographic and weight status subgroups.A sample of racially and socioeconomically diverse pregnant women from a northeastern US city was assigned to the intervention group in a randomized controlled trial to prevent excessive gestational weight gain (n=1014). The intervention website included these features: weight-gain tracker, health-related articles, blogs, physical activity and diet goal-setting tools, and local resources. Engagement variables were created to capture the amount, consistency, and patterns of feature use across pregnancy using latent class analysis. Demographic/weight status subgroups were also created using latent class analysis. Differences in engagement across the demographic/weight status subgroups were examined using chi-square analysis.Six engagement patterns emerged: "super-users" (13.02%, 132/1014), "medium-users" (14.00%, 142/1014), "consistent weight-tracker users" (14.99%, 152/1014); "almost consistent weight-tracker users" (21.99%, 223/1014), "inconsistent weight-tracker users" (15.98%, 162/1014), and "non-users" (20.02%, 203/1014). Four demographic/weight status subgroups emerged: three minority and one white. There were different engagement patterns by demographic/weight status subgroups. Super-users were more likely to be in the white subgroup, while non-users were more likely to be in the minority subgroups. However, around a third of women in minority subgroups were consistently or almost consistently engaging with the weight-tracker (black, young women, 32.2%, 67/208; black, heavier women, 37.9%, 50/132; Hispanic women, 27.4%, 32/117).While white and higher income women had higher engagement in general, depending on the measure, there was still considerable engagement by the minority and low-income women.Clinicaltrials.gov: NCT01331564; http://clinicaltrials.gov/ct2/show/NCT01331564 (Archived by WebCite at http://www.webcitation.org/6Rw4yKxI5).

Dataset Information

Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial.

Publications

Effectiveness of SmartMoms, a Novel eHealth Intervention for Management of Gestational Weight Gain: Randomized Controlled Pilot Trial.

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