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Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial.

ABSTRACT: Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child. Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers, as well as reduced risk of adverse pregnancy outcomes. There is however a lack of high quality, randomized controlled trials on the effects of regular exercise training in pregnancy, especially those with a pre-pregnancy body mass index (BMI) at or above 30 kg/m2.We are conducting a randomised, controlled trial in Norway with two parallel arms; one intervention group and one control group. We will enroll 150 previously sedentary, pregnant women with a pre-pregnancy BMI at or above 30 kg/m2. The intervention group will meet for organized exercise training three times per week, starting in gestation week 14 (range 12-16). The control group will get standard antenatal care. The main outcome measure will be weight gain from baseline to delivery. Among the secondary outcome measures are changes in exercise capacity, endothelial function, physical activity level, body composition, serum markers of cardiovascular risk, incontinence, lumbopelvic pain and cardiac function from baseline to gestation week 37 (range 36-38). Offspring outcome measures include anthropometric variables at birth, Apgar score, as well as serum markers of inflammation and metabolism in cord blood.The results of this trial will provide knowledge about effects of regular exercise training in previously sedentary, obese pregnant women. If the program proves effective in reducing gestational weight gain and adverse pregnancy outcomes, such programs should be considered as part of routine pregnancy care for obese women.ClinicalTrials.gov: NCT01243554.

SUBMITTER: Moholdt TT

PROVIDER: S-EPMC3148988 | biostudies-literature | 2011 Jun

REPOSITORIES: biostudies-literature

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Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial.

Moholdt Trine T TT Salvesen Kjell K Ingul Charlotte B CB Vik Torstein T Oken Emily E Mørkved Siv S

Trials 20110617

<h4>Unlabelled</h4><h4>Background</h4>Both maternal pre-pregnancy obesity and excessive gestational weight gain are increasing in prevalence and associated with a number of adverse pregnancy outcomes for both mother and child. Observational studies regarding physical activity in pregnancy have found reduced weight gain in active mothers, as well as reduced risk of adverse pregnancy outcomes. There is however a lack of high quality, randomized controlled trials on the effects of regular exercise ...[more]

PMID: 21682869

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Project description:BackgroundThe effectiveness of exercise training for preventing excessive gestational weight gain (GWG) and gestational diabetes mellitus (GDM) is still uncertain. As maternal obesity is associated with both GWG and GDM, there is a special need to assess whether prenatal exercise training programs provided to obese women reduce the risk of adverse pregnancy outcomes. Our primary aim was to assess whether regular supervised exercise training in pregnancy could reduce GWG in women with prepregnancy overweight/obesity. Secondary aims were to examine the effects of exercise in pregnancy on 30 outcomes including GDM incidence, blood pressure, blood measurements, skinfold thickness, and body composition.Methods and findingsThis was a single-center study where we randomized (1:1) 91 pregnant women with a prepregnancy body mass index (BMI) ≥ 28 kg/m2 to exercise training (n = 46) or control (standard maternity care) (n = 45). Assessments were done at baseline (pregnancy week 12-18) and in late pregnancy (week 34-37), as well as at delivery. The exercise group was offered thrice weekly supervised sessions of 35 min of moderate intensity endurance exercise and 25 min of strength training. Seventeen women were lost to follow-up (eight in the exercise group and nine in the control group). Our primary endpoint was GWG from baseline testing to delivery. The principal analyses were done as intention-to-treat analyses, with supplementary per protocol analyses where we assessed outcomes in the women who adhered to the exercise program (n = 19) compared to the control group. Mean GWG from baseline to delivery was 10.5 kg in the exercise group and 9.2 kg in the control group, with a mean difference of 0.92 kg (95% CI -1.35, 3.18; p = 0.43). Among the 30 secondary outcomes in late pregnancy, an apparent reduction was recorded in the incidence of GDM (2009 WHO definition) in the exercise group (2 cases; 6.1%) compared to the control group (9 cases; 27.3%), with an odds ratio of 0.1 (95% CI 0.02, 0.95; p = 0.04). Systolic blood pressure was significantly lower in the exercise group (mean 120.4 mm Hg) compared to the control group (mean 128.1 mm Hg), with a mean difference of -7.73 mm Hg (95% CI -13.23, -2.22; p = 0.006). No significant between-group differences were seen in diastolic blood pressure, blood measurements, skinfold thickness, or body composition in late pregnancy. In per protocol analyses, late pregnancy systolic blood pressure was 115.7 (95% CI 110.0, 121.5) mm Hg in the exercise group (significant between-group difference, p = 0.001), and diastolic blood pressure was 75.1 (95% CI 71.6, 78.7) mm Hg (significant between-group difference, p = 0.02). We had planned to recruit 150 women into the trial; hence, under-recruitment represents a major limitation of our results. Another limitation to our study was the low adherence to the exercise program, with only 50% of the women included in the intention-to-treat analysis adhering as described in the study protocol.ConclusionsIn this trial we did not observe a reduction in GWG among overweight/obese women who received a supervised exercise training program during their pregnancy. The incidence of GDM in late pregnancy seemed to be lower in the women randomized to exercise training than in the women receiving standard maternity care only. Systolic blood pressure in late pregnancy was also apparently lower in the exercise group than in the control group. These results indicate that supervised exercise training might be beneficial as a part of standard pregnancy care for overweight/obese women.Trial registrationClinicalTrials.gov NCT01243554.

Project description:OBJECTIVES:Women with high body mass index (BMI) have increased risk for symptoms of anxiety and depression during pregnancy and postpartum. In this prespecified secondary analysis from the exercise training in pregnancy trial, our aim was to examine effects of supervised exercise during pregnancy on psychological well-being in late pregnancy and postpartum among women with a prepregnancy BMI ?28?kg/m2. DESIGN:Single-centre, parallel group, randomised controlled trial. SETTING:University Hospital, Norway. PARTICIPANTS:Ninety-one women (age 31.2±4.1 years, BMI 34.5±4.2?kg/m2), 46 in the exercise group, 45 in the control group, were included in the trial. INTERVENTION:The exercise group was offered 3?weekly supervised exercise sessions (35?min of moderate intensity walking/running and 25?min of resistance training), until delivery. PRIMARY AND SECONDARY OUTCOMES MEASURES:Primary analyses were based on intention to treat, with secondary perprotocol analyses. To assess psychological well-being, we used the 'Psychological General Well-Being Index' (PGWBI) at inclusion (gestational week 12-18), late pregnancy (gestational week 34-37) and 3?months postpartum. We assessed postpartum depression using the 'Edinburgh Postnatal Depression Scale' (EPDS). RESULTS:Numbers completed data collection: late pregnancy 72 (exercise 38, control 36), postpartum 70 (exercise 36, control 34). In the exercise group, 50% adhered to the exercise protocol. Baseline PGWBI for all women was 76.4±12.6. Late pregnancy PGWBI; exercise 76.6 (95% CI 72.2 to 81.0), control 74.0 (95% CI 69.4 to 78.5) (p=0.42). Postpartum PGWBI; exercise 85.4 (95% CI 81.9 to 88.8), control 84.6 (95% CI 80.8 to 88.4) (with no between-group difference, p=0.77). There was no between-group difference in EPDS; exercise 2.96 (95% CI 1.7 to 4.2), control 3.48 (95% CI 2.3 to 4.7) (p=0.55). CONCLUSIONS:We found no effect of supervised exercise during pregnancy on psychological well-being among women with high BMI. Our findings may be hampered by low adherence to the exercise protocol. TRIAL REGISTRATION NUMBER:NCT01243554.

Project description:BackgroundThere is increasing evidence of weight regain in patients after bariatric surgery (BS), generally occurring from 12 to 24 months postoperatively. Postoperative exercise has been suggested to ad long-term weight maintenance and to improve physical function in BS patients. However, there are a limited number of intervention studies investigating the possible benefits of exercise in this population. The aim of the current report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the exercise programme implemented in the EFIBAR Study (Ejercicio FÍsico tras cirugía BARiátrica), a randomised controlled trial investigating the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, physical activity and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery.MethodsA total of 80 BS patients [60-80% expected women, aged 18 to 60 years, body mass index (BMI) ≥ 40 kg/m2 or ≥ 35 kg/m2 with comorbid conditions)] will be enrolled in the EFIBAR Randomized Control Trial (RCT). Participants allocated in the exercise group (n = 40) will undertake a 16-week supervised concurrent (strength and aerobic) exercise programme (three sessions/week, 60 min/session), starting 7 to 14 days after surgery. The rationale of the exercise programme will be described following the CERT criteria detailing the 16 key items. The study has been reviewed and approved by the Ethics Committee of the Torrecárdenas University Hospital (Almería, Spain) (ref. N° 76/2016).DiscussionThe present study details the exercise programme of the EFIBAR RCT, which may serve: 1) exercise professionals who would like to implement an evidence-based exercise programme for BS patients, and 2) as an example of the application of the CERT criteria.Trial registrationThe trial was prospectively registered at Clinicaltrials.gov NCT03497546 on April 13, 2018.

Project description:BACKGROUND:The prevalence of maternal obesity is rising. Pre-pregnancy obesity is associated with later cardiovascular disease in the child and the underlying pathogenesis begins in early life. Therefore, pregnancy and infancy are key periods for potential intervention. The aim of this study was to study the cardiac function in newborns of obese women compared to newborns of normal-weight women, and to determine if exercise intervention during pregnancy could have an effect on cardiac function of newborns to obese women. MATERIAL AND METHODS:Fifty-five pregnant women, 51 obese (BMI ? 30 kg/m2) and four overweight (BMI 28-30 kg/m2), were randomized to an exercise training group (n = 27) or a control group (standard maternity care, n = 28). From gestational week 14 until delivery participants in the intervention group were offered supervised training sessions three times weekly. In addition, they were told to exercise at home once weekly. All newborns had an echocardiogram performed 1-3 days and 6-8 weeks after delivery. The results were compared with newborns of normal weight women (n = 20, standard maternity care). RESULTS:Newborns of obese women had an impaired systolic and diastolic cardiac function with reduced global strain, strain rate, tissue Doppler velocities and a thicker intraventricular septum at birth and after 6-8 weeks after delivery compared to newborns of normal weight women. Exercise had no statistically significant effect on either of the cardiac function parameters. The mean (± standard deviation) adherence to the exercise protocol was 1.3 ± 0.8 sessions per week for supervised training and 0.8 ± 0.7 sessions per week for home-based exercise training. CONCLUSIONS:Newborns of obese women had reduced cardiac function and thicker intraventricular septum compared to newborns of normal weight women. Exercise training during pregnancy had no significant effect, potentially due to a low number of subjects and low adherence to the exercise protocol. TRIAL REGISTRATION:ClinicalTrials.gov NCT01243554.

Project description:The proportion of women entering pregnancy overweight or obese has been rising and, in turn, is associated with adverse maternal and fetal outcomes. Gestational weight gain (GWG) exceeding Institute of Medicine (IOM) guidelines further increases health risks and has been independently associated with postpartum weight retention. Hispanic women are disproportionately affected by overweight and obesity, but have had limited access to interventions that promote healthy lifestyles due to cultural, socioeconomic, and language barriers. Therefore, the overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually-tailored lifestyle intervention to reduce excess GWG, increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.Overweight/obese Hispanic women are recruited in early pregnancy and randomly assigned to a Lifestyle Intervention (n = 150) or a Comparison Health and Wellness (control) intervention (n = 150). Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) are used to deliver the intervention from early pregnancy (12 weeks gestation) to 6 months postpartum, with follow-up to 1 year postpartum. Targets of the intervention are to achieve IOM Guidelines for GWG and postpartum weight loss; American Congress of Obstetrician and Gynecologist guidelines for physical activity; and American Diabetes Association guidelines for diet. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies to address the specific social, cultural, and economic challenges faced by low-income Hispanic women. Assessments are conducted at baseline (~10 weeks gestation), mid pregnancy (24-28 weeks gestation), late pregnancy (32-34 weeks gestation) and postpartum at 6-weeks, 6-months, and 12-months by bicultural and bilingual personnel blinded to the intervention arm. Efficacy is assessed via GWG, postpartum weight loss, and biomarkers of glycemic control, insulin resistance, and cardiovascular disease risk factors. Changes in physical activity and diet are measured via 7-day accelerometer data and 24-h dietary recalls at each assessment time period.Hispanic women are the fastest growing minority group in the U.S. and are disproportionately affected by overweight and obesity. This randomised trial uses a high-reach, low-cost strategy that can readily be translated into clinical practice in underserved and minority populations.NCT01868230 May 29, 2013.

Project description:IntroductionIncreasing evidence suggests obesity has its origins prior to birth. There is clear correlation between maternal obesity, high birthweight and offspring risk of obesity in later life. It is also clear that women who are obese during pregnancy are at greater risk of adverse outcomes, including gestational diabetes and stillbirth. The mechanism(s) by which obesity causes these problems is unknown, although hyperglycaemia and insulin resistance are strongly implicated. We present a protocol for a study to test the hypothesis that metformin will improve insulin sensitivity in obese pregnant women, thereby reducing the incidence of high birthweight babies and other pregnancy complications.Methods and analysisThe Efficacy of Metformin in Pregnant Obese Women, a Randomised controlled (EMPOWaR) trial is a double-masked randomised placebo-controlled trial to determine whether metformin given to obese (body mass index >30 kg/m(2)) pregnant women from 16 weeks' gestation until delivery reduces the incidence of high birthweight babies. A secondary aim is to test the mechanism(s) of any effect. Obese women with a singleton pregnancy and normal glucose tolerance will be recruited prior to 16 weeks' gestation and prescribed study medication, metformin or placebo, to be taken until delivery. Further study visits will occur at 28 and 36 weeks' gestation for glucose tolerance testing and to record anthropometric measurements. Birth weight and other measurements will be recorded at time of delivery. Anthropometry of mother and baby will be performed at 3 months postdelivery. As of January 2014, 449 women had been randomised across the UK.Ethics and disseminationThe study will be conducted in accordance with the principles of Good Clinical Practice. A favourable ethical opinion was obtained from Scotland A Research Ethics Committee, reference number 10/MRE00/12. Results will be disseminated at conferences and published in peer-reviewed journals.Trial registration numberISRCTN51279843.

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Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial.

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Exercise Training in Pregnancy for obese women (ETIP): study protocol for a randomised controlled trial.

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