Feasibility, acceptability and efficacy of a web-based computer-tailored physical activity intervention for pregnant women - the Fit4Two randomised controlled trial (original) (raw)
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International Journal of Environmental Research and Public Health
Physical activity during pregnancy is a public health issue. In the view of reproducibility and the successful implementation of exercise interventions, reporting the quality of such study design must be ensured. The objective of this study was to develop and validate a physical exercise program promoting fitness and health during pregnancy. A qualitative methodological study was carried out. For the description of the exercise program, the Consensus on Exercise Reporting Template (CERT) was used. For the validation of the program, the revised guideline of the Criteria for Reporting the Development and Evaluation of Complex Interventions in Health Care (CReDECI2) was followed and went through three stages of development, piloting, and evaluation. The customizable exercise program was designed and validated by exercise and health specialists based on evidence-based, international recommendations and supported by different educational tools to be implemented by qualified exercise prof...
Sustainability
Background: Regular physical activity (PA) practice during pregnancy offers health and fitness benefits for both mother and baby. Therefore, healthy pregnant women with no contraindications to exercise should be encouraged to perform PA. Nevertheless, their levels of PA are generally low. The aim of the WELL-DONE! Study is to co-design an adapted physical activity intervention (APAI) for pregnant women to include in childbirth preparation classes (CPCs) evaluating its feasibility and efficacy on quality of life (QoL), PA levels and other outcomes. Methods: A quasi-experimental study was divided in two progressive stages. First, APAI was developed in collaboration with pregnant women and midwives using focus groups; second, APAI’s efficacy was evaluated comparing two groups: the experimental group engaged in the CPCs integrated with 1 h/week of the APAI administered by midwives and the control group participating in the standard CPCs. Pre-post evaluation was carried out in three stag...
2019
BACKGROUND Obesity in pregnancy is a growing problem worldwide, with excessive gestational weight gain (GWG) occurring in the majority of pregnancies. This significantly increases risks to mother and child. A major contributor to both pre-pregnancy obesity and excessive GWG is physical inactivity, however past interventions targeting maternal weight gain and activity levels during the antenatal period have been ineffective in women who are already overweight. Pedometer-guided activity may offer a novel solution to increasing activity levels in this population. OBJECTIVE Our aim in this initial feasibility randomized controlled trial was to test a pedometer-based intervention to increase activity and reduce excessive GWG in thirty pregnant women. METHODS Thirty pregnant women with obesity were supplied with a Fitbit Zip® pedometer, and randomized to one of three groups; Control: pedometer-only; App: pedometer-synched to patients’ personal smartphones, with self-monitoring of activity...
Background: Interventions targeting physical activity and sedentary behavior concurrently in pregnancy may be an ideal strategy to reduce the risk of pregnancy complications. We assessed the feasibility, acceptability, and preliminary efficacy of a single-arm, remotely-delivered health coaching intervention to promote physical activity and reduce sedentary behavior in pregnancy.Methods: Women (n=34) between 8-12 weeks gestation were recruited to take part in the INcreasing Steps in PREgnancy (INSPiRE) study. Participants were given an activity tracker (Fitbit Inspire) and met virtually with their health coach throughout the second and third trimesters of pregnancy. Feasibility was based on enrollment, retention, and adherence rates. Acceptance was assessed using a process evaluation survey. Intervention efficacy was based on activPAL data obtained at baseline and the end of the second trimester. Results: Feasibility objectives were met, with greater than 70% enrollment, 97% retentio...
Purpose: Physical activity (PA) typically declines throughout pregnancy. Low levels of PA are associated with excessive weight gain and subsequently increase risk of pre-eclampsia, gestational diabetes mellitus, hypertension disorders, delivery by caesarean section and stillbirth. Systematic reviews on PA during pregnancy have not explored the efficacy of behaviour change techniques or related theory in altering PA behaviour. This systematic review evaluated the content of PA interventions to reduce the decline of PA in pregnant women with a specific emphasis on the behaviour change techniques employed to elicit this change.
BMC Public Health
Background Physical activity (PA) at moderate intensity is recommended for healthy pregnant women. The three-arm FitMum randomised controlled trial showed that it was possible to increase PA level during pregnancy with structured supervised exercise training (EXE) compared to standard care. Motivational counselling on PA (MOT) did not increase PA. This process evaluation aims to understand the implementation and mechanisms of impact of EXE and MOT. Methods A mixed methods process evaluation was conducted using the UK Medical Research Council’s process evaluation framework by assessing implementation (reach, fidelity, and dose) and mechanisms of impact of the two interventions provided to pregnant women in FitMum. Data was collected both quantitatively (n = 220) and qualitatively (n = 20). Results The FitMum trial reached educated pregnant women (80% having an educational level ≥ bachelor’s degree) with high autonomy of everyday life. Most participants (58%) were recruited at their f...
A Pilot Study Evaluating a Telephone-Based Exercise Intervention for Pregnant and Postpartum Women
Journal of Midwifery & Women's Health, 2011
Introduction: Exercise during pregnancy is associated with reduced rates of preeclampsia, gestational diabetes, anxiety, insomnia, and excessive weight gain. Continued exercise during the postpartum period is important for healthy weight loss and reduced anxiety. Unfortunately, pregnant and postpartum women are significantly less active than nonpregnant women. The purpose of this pilot study was to evaluate a telephone-based exercise intervention designed for pregnant and postpartum women. Methods: Healthy women (N = 37) who were pregnant (16 weeks' gestation or less) or postpartum (6 months or less) participated in a 3-month, telephone-based exercise intervention based on the transtheoretical model and social cognitive theory. Exercise was assessed by using the 7-Day Physical Activity Recall Interview. Results: Pregnant participants significantly increased their exercise from a mean (standard deviation [SD]) of 60.47 (63.1) minutes per week at baseline to 132.9 (82.3) minutes at 3 months, F(1,13) = 9.96, P Ͻ .01. Postpartum participants significantly increased their exercise from a mean (SD) of 68.9 (63.5) minutes per week at baseline to 123.8 (48.8) minutes at 3 months, F(1,15) = 6.56, P Ͻ .05. Discussion: Participants responded positively to the intervention by significantly increasing their exercise levels. There is a need for a large, randomized controlled trial examining the efficacy of telephone-based exercise interventions for pregnant and postpartum women.
BMJ Open, 2021
Introduction A physically active lifestyle during pregnancy improves maternal and offspring health but can be difficult to follow. In Denmark, less than 40% of pregnant women meet physical activity (PA) recommendations. The FitMum study aims to explore strategies to increase PA during pregnancy among women with low PA and assess the health effects of PA. This paper presents the FitMum protocol, which evaluates the effects of structured supervised exercise training or motivational counselling supported by health technology during pregnancy on PA level and health of mother and offspring. Methods and analysis A single-site three-arm randomised controlled trial that aims to recruit 220 healthy, pregnant women with gestational age (GA) no later than week 15 and whose PA level does not exceed one hour/week. Participants are randomised to one of three groups: structured supervised exercise training consisting of three weekly exercise sessions, motivational counselling supported by health t...
Background: 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. Methods/Design: 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.
Clinical and experimental obstetrics & gynecology, 2024
Background: Obesity is common in women of reproductive age and increases the risk during pregnancy. Exercising during this period reduces health complications. Home e-health programs are effective in overcoming exercise barriers as pregnant women use technology and the internet for health information. Methods: A single-blind randomized controlled feasibility study with pregnant women with obesity (body mass index [BMI] ≥30 kg/m 2) was conducted in the University Hospital Center of São João between January and April 2023. Pregnant women were randomized to a control group with standard care and to an experimental group with 8-week remote exercise program using a Phoenix® biofeedback device. Feasibility outcome measures were recruitment rate (≥35%), loss to follow-up (≤15%), and program fidelity (≥1 session/week). Secondary outcomes were evaluated through Pregnancy Physical Activity Questionnaire, Oswestry Index on Disability, and weight assessments at baseline and at the end of the program. Results: Of the 63 eligible participants, 24 (38.1%) were successfully randomized and completed the baseline assessment. Of these, 3 (4.8%) from experimental group did not perform the initial onboarding. The control group had 8.3% of follow-up losses and for the experimental group there were no follow-up losses. Program fidelity (mean ≥1 session/week) was fulfilled by 66.7% of successfully randomized participants. Regarding secondary outcomes assessed between baseline and the 8th week, experimental group compared to control group had higher levels of physical activity for sports activities, a lower level of inactivity, and lower disability rates caused by low back pain. Conclusions: Based on the recruitment rate, losses to follow-up, and fidelity rate, the GROB (obesity in pregnancy) study was deemed feasible and worthy of consideration for a larger study. Moreover, the GROB study has the potential to improve maternal outcomes by reducing sedentarism and disability caused by low back pain. Clinical Trial Registration: The study has been registered on https://classic.clinicaltrials.gov/ (registration number: NCT05331586).