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Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial.

ABSTRACT: Preterm birth is associated with most cases of neonatal deaths and negative health outcomes, and hypertensive disorders. Hypertension is influenced by maternal behavior, such as physical activity. Physical activity is associated with better outcomes for mother and fetus, besides healthier weight gains during pregnancy. Few women are physically active during pregnancy and few clinical trials have been carried out with pregnant women. The aim of this paper is to describe the protocol of a controlled trial evaluating whether regular exercise during pregnancy may result in improved maternal-child health and neonatal outcomes.The PAMELA (Physical Activity for Mothers Enrolled in Longitudinal Analysis) trial is a randomized controlled trial nested in a birth cohort study. Eligible women belonging to the birth cohort will be invited (between the 16th and 20th week of gestation) to enroll in the trial. Baseline data (blood and urine samples, anthropometry and pulmonary function) will be collected at enrollment. The same assessments will be repeated eight and 16 weeks after baseline. After randomization, women will be allocated into either one of these groups: control, 426 women who will be advised to keep their usual daily activities; and intervention, 213 women who will engage in an exercise program, three sessions a week. At least 70 % attendance over 16 weeks will be required to be considered compliant to the intervention. Exercise protocol will include aerobics, strength and flexibility training. Maternal and child outcomes will be measured at the 36th week of gestation, at birth and at three, 12, 24 and 48 months postpartum. An intention-to-treat analysis will be performed.Few women are active during pregnancy and a vast majority decrease their activities or even quit exercising. We present a population-based regular exercise intervention focused on the prevention of hypertension, pre-eclampsia and preterm birth. Data on the underlying cohort will allow future analysis using different outcomes with low probability of recall bias or misclassification of exposure status. Results will potentially influence prenatal care counseling in regards to physical activity.Clinicaltrials.gov identifier: NCT02148965 , registered on 22 May 2014.

SUBMITTER: Domingues MR

PROVIDER: S-EPMC4446829 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial.

Domingues Marlos Rodrigues MR Bassani Diego Garcia DG da Silva Shana Ginar SG Coll Carolina de Vargas Nunes Cde V da Silva Bruna Gonçalves Cordeiro BG Hallal Pedro Curi PC

Trials 20150524

<h4>Background</h4>Preterm birth is associated with most cases of neonatal deaths and negative health outcomes, and hypertensive disorders. Hypertension is influenced by maternal behavior, such as physical activity. Physical activity is associated with better outcomes for mother and fetus, besides healthier weight gains during pregnancy. Few women are physically active during pregnancy and few clinical trials have been carried out with pregnant women. The aim of this paper is to describe the pro ...[more]

PMID: 26003406

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Project description:BackgroundWomen are encouraged to be physically active during pregnancy. Despite available evidence supporting antenatal physical activity to bring health benefits for both the mother and child, the most effective way to prevent some maternal and fetal outcomes is still unclear. The purpose of this study was to evaluate the efficacy of an exercise intervention to prevent negative maternal and newborn health outcomes.MethodsA randomized controlled trial (RCT) nested into the 2015 Pelotas (Brazil) Birth Cohort Study was carried-out with 639 healthy pregnant women, 213 in the intervention group (IG) and 426 in the control (CG) group. An exercise-based intervention was conducted three times/week for 16 weeks from 16-20 to 32-36 weeks' gestation. The main outcomes were preterm birth and pre-eclampsia. Gestational age was calculated based on several parameters, including routine ultrassounds and/or last menstrual period and categorized as < 37 weeks and ≥ 37 weeks for evaluation of preterm birth. Pre-eclampsia was self-reported. Secondary outcomes were gestational weight gain, gestational diabetes, birth weight, infant length, and head circumference. Analyses were performed by intention-to-treat (ITT) and per protocol (70% of the 48 planned exercise sessions). Odds ratio were derived using unconditional logistic regression.ResultsThe IG and CG did not differ at baseline regarding their mean age (27.2 years ± 5.3 vs. 27.1 years ± 5.7) and mean pre-pregnancy body mass index (25.1 ± 3.9 vs. 25.2 ± 4.1 kg/m2). The mean adherence to the exercise intervention was 27 ± 17.2 sessions (out of a potential 48) with 40.4% attending > = 70% of the recommended exercise sessions. A total of 594 participants (IG:198; CG: 396) were included in the ITT and 479 (IG: 83; CG: 396) were included in the per protocol analyses. There were no significant differences in the incidence of preterm birth and pre-eclampsia between groups in the ITT and per protocol analysis. There were also no differences between the two groups in mean gestational weight gain, gestational diabetes, birth weight, infant length, and head circumference.ConclusionsWhile the RCT did not support the benefits of exercise performed during pregnancy on preeclampsia and preterm birth, the exercise program also did not present adverse impacts on newborn health. Our findings may contribute to promote intervention strategies that motivate health providers to encourage pregnant women to be more physically active.Trial registrationClinicaltrials.gov identifier: NCT02148965 , registered on 22 May 2014.

Project description:BackgroundLow levels of physical activity are associated with numerous adverse health outcomes, yet sedentary lifestyles are common among both children and adults. Physical activity levels tend to decline steeply among children aged between 8 and 12 years, even though children's behavioral patterns are largely governed by familial structures. Similarly, parents' activity levels have been generally reported as lower than those of nonparents of comparable age. For this reason, family-based physical activity promotion interventions are a potentially valuable and relatively underresearched method for mitigating physical activity declines as children develop into adolescents and for increasing physical activity in parents.ObjectiveThis study aims to assess the efficacy, feasibility, and acceptability of a novel theory-based web-based physical activity promotion intervention among parent-child dyads in Finland who do not meet physical activity recommendations at baseline.MethodsParticipants (target N=254) will be recruited from the general population using a panel company and advertisements on social media and randomly assigned to either an immediate intervention group or a waitlist control group. The intervention consists of 4 web-based group workshops over the course of 10 weeks, web-based tasks and resources, and a social support chat group. Data on physical activity behavior and constructs from the integrated behavior change model will be collected through self-report surveys assessing physical activity, autonomy support, autonomous motivation, attitude, subjective norm, perceived behavioral control, intention, self-monitoring, habit, and accelerometer measurements at baseline, post intervention, and 3 months post intervention. Exit interviews with participants will assess the feasibility and acceptability of the intervention procedures.ResultsThis study will reveal whether the intervention changes leisure-time physical activity among intervention participants relative to the control group and will examine the intervention's effects on important theoretical predictors of physical activity. It will also yield data that can be used to refine intervention materials and inform further implementation. Trial recruitment commenced in September 2023, and data collection should be completed by December 2024.ConclusionsThe planned intervention has potential implications for both theory and practice. Practically, the use of an entirely web-based intervention may have scalable future uses for improving physical activity in 2 key populations, while also potentially informing on the value of dyadic, family-based strategies for encouraging an active lifestyle as an alternative to strategies that target either parents or children independently. Further, by assessing change in psychological constructs alongside potential change in behavior, the intervention also allows for important tests of theory regarding which constructs are most linked to favorable behavior change outcomes.Trial registrationClinicalTrials.gov NCT06070038; https://clinicaltrials.gov/study/NCT06070038.International registered report identifier (irrid)DERR1-10.2196/55960.

Project description:BackgroundAdequate intake of macro- and micronutrients and adoption of an active lifestyle during pregnancy are essential for optimum maternal and fetal health and offspring development. Dietary counseling and advice regarding adequate physical activity are integral components of antenatal care. Personalized coaching through the use of mobile health (mHealth) that supports behavior modification is an innovative approach that needs exploration.ObjectiveOur primary aim is to assess the efficacy of an mHealth program in improving diet, supplement use, and physical activity during pregnancy. Secondary objectives include evaluation of the program's effect on maternal and offspring health outcomes and assessment of its compliance and usability.MethodsA randomized controlled trial was initiated at the Aga Khan University Hospital in Karachi, Pakistan, in January 2020. We aim to recruit 300 pregnant women in their first trimester who have smartphones, do not have comorbidities, and are not taking medications. The intervention group will be trained to use an mHealth app called PurUmeed Aaghaz. Through this app, the subjects will report information about their diet, supplement use, and physical activity and will receive personalized advice and three push messages as weekly reminders. The research assistant will obtain similar information from the control group via a paperless questionnaire; this group will receive standard face-to-face counseling regarding diet, supplement use, and physical activity. Data will be collected at enrollment and during four follow-up sessions scheduled 6 weeks apart. Primary study outcomes include improvements in diet (ie, change in mean dietary risk score from baseline to each follow-up), supplement use (ie, changes in mean supplement use score and biochemical levels of folic acid, iron, calcium, and vitamin D on a study subset), and mean duration of reported physical activity (minutes). Secondary study outcomes relate to maternal health (ie, gestational diabetes mellitus, gestational hypertension, pre-eclampsia, and gestational weight gain), newborn health (ie, birth weight and length and gestational age at delivery), and infant health (ie, BMI and blood pressure at 1 year of age). Compliance will be determined by the proportion of participants who complete the 6-month coaching program. Usability will be assessed based on features related to design, interface, content, coaching, perception, and personal benefit.ResultsThe study was approved by the Ethics Review Committee of the Aga Khan University in 2017. The recruitment of study participants was completed in September 2021. All follow-ups and outcome assessments are expected to be completed by March 2023 and analysis is expected to be completed by June 2023. We expect the results to be published by the end of 2023.ConclusionsThis study will be an important step toward evaluating the role of mHealth in improving behaviors related to a healthy diet, supplement use, and promotion of physical activity during pregnancy, as well as in influencing maternal and offspring outcomes. If proven effective, mHealth interventions can be scaled up and included in antenatal care packages at tertiary care hospitals of low- and middle-income countries.Trial registrationClinicalTrials.gov NCT04216446; https://clinicaltrials.gov/ct2/show/NCT04216446.International registered report identifier (irrid)DERR1-10.2196/31611.

Project description:BackgroundMany women try to stop smoking in pregnancy but fail. One difficulty is that there is insufficient evidence that medications for smoking cessation are effective and safe in pregnancy and thus many women prefer to avoid these. Physical activity (PA) interventions may assist cessation; however, trials examining these interventions have been too small to detect or exclude plausible beneficial effects. The London Exercise And Pregnant smokers (LEAP) trial is investigating whether a PA intervention is effective and cost-effective when used for smoking cessation by pregnant women, and will be the largest study of its kind to date.Methods/designThe LEAP study is a pragmatic, multi-center, two-arm, randomized, controlled trial that will target pregnant women who smoke at least one cigarette a day (and at least five cigarettes a day before pregnancy), and are between 10 and 24 weeks pregnant. Eligible patients are individually randomized to either usual care (that is, behavioral support for smoking cessation) or usual care plus a intervention (entailing supervised exercise on a treadmill plus PA consultations). The primary outcome of the trial is self-reported and biochemically validated continuous abstinence from smoking between a specified quit date and the end of pregnancy. The secondary outcomes, measured at 1 and 4 weeks after the quit date, and at the end of pregnancy and 6 months after childbirth, are PA levels, depression, self-confidence, and cigarette withdrawal symptoms. Smoking status will also be self-reported at 6 months after childbirth. In addition, perinatal measures will be collected, including antenatal complications, duration of labor, mode of delivery, and birth and placental weight. Outcomes will be analyzed on an intention-to-treat basis, and logistic regression models used to compare treatment effects on the primary outcome.DiscussionThis trial will assess whether a PA intervention is effective when used for smoking cessation during pregnancy.Trial registrationISRCTN48600346.

Project description:Physical activity is associated with the reduction of several chronic conditions in adults. Additionally, physical activity is extremely important for children for their development and cognitive functioning and also to create a physically active lifestyle that continues into adulthood. Despite the known benefits of physical activity, only one in five adults are achieving the public health recommendations of 150 minutes of moderate-to-vigorous physical activity per week and only 13 % of boys and 6 % of girls between the ages of 5 and 17 years are meeting the guidelines of 60 minutes per day. This study aims to evaluate whether a planning condition improves adherence to regular physical activity compared to an education-only control condition among families. Families are eligible if there is at least one child between the ages of 6 and 12 years who is not meeting the Canadian Physical Activity Guidelines.A six-month longitudinal randomized controlled trial will be used to compare the two conditions. Materials will be delivered at baseline with 'booster' sessions at six weeks and three months. Participants will be assessed at baseline and at six months with a fitness test, as well as questionnaires and accelerometery at baseline, six weeks, three months and six months. A total of 137 families have been recruited thus far from Greater Victoria. This study is ongoing and recruitment will continue until December 2015 with the target goal of reaching 160 families.This protocol describes the implementation of a randomized controlled trial that utilizes planning strategies to try and increase physical activity among families. Research findings could be useful in public health in providing effective strategies to families to help decrease sedentary lifestyles. Additionally, findings may help to inform future interventions aimed at increasing physical activity among families.This trial was registered on June 5, 2012 with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health. The registration ID is NCT01882192.

Project description:BackgroundThe Government of Cambodia established the village health support groups (VHSGs) in 2003 to facilitate primary healthcare activities, including maternal and child health (MCH) services. However, VHSGs face several challenges that hinder them from performing optimally, including a lack of regular structured training and remuneration and limited and inconsistent support and supervision from the health centers (HCs). This implementation research aims to develop, implement, and evaluate a digital health intervention to improve the performance of VHSGs through better support and supervision and increase the MCH service coverage in rural Cambodia.Methodsi-MoMCARE, a two-arm cluster randomized controlled trial, will be conducted between 2022 and 2025. Five operational districts (ODs) have been randomized to an intervention arm and the other five ODs to the control arm. The intervention will last for 24 months. Around 200 VHSGs in the intervention arm will be equipped with a mobile application as a job aid and 20 HC staff with a web interface to improve support and supervision of VHSGs. The potential beneficiaries will include pregnant women, mothers, and children under 2 years old. We will measure the outcomes at baseline and endline. The primary outcomes will consist of a composite MCH index constructed from maternal and newborn care indicators, child immunization, and treatment of under-two children. Secondary outcomes will include coverage of selected MCH services. We will conduct the intention-to-treat and per-protocol analyses. We will conduct qualitative interviews with selected beneficiaries and stakeholders to evaluate the intervention's acceptability, feasibility, and scalability. We will also conduct a cost-effective analysis using decision-analytic modeling incorporating a societal perspective that explores different time horizons, intervention effects, and when scaled up to the national level.Discussioni-MoMCARE is expected to increase MCH service access and coverage in rural Cambodia. It will contribute to advancing digital health use in primary healthcare interventions, which remains in its infancy in the country. Furthermore, the study findings will be a valuable addition to a growing body of literature on the effectiveness and feasibility of mobile health to improve coverage of MCH services in rural low- and middle-income country settings.Trial registrationClinicalTrial.gov NCT05639595. Registered on 06 December 2022.

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Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial.

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Physical activity during pregnancy and maternal-child health (PAMELA): study protocol for a randomized controlled trial.

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