scholarly journals Towards Prepared mums (TOP-mums) for a healthy start, a lifestyle intervention for women with overweight and a child wish: study protocol for a randomised controlled trial in the Netherlands

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e030236
Author(s):  
Yvon E G Timmermans ◽  
Kim D G van de Kant ◽  
Dorien Reijnders ◽  
Lina M P Kleijkers ◽  
Edward Dompeling ◽  
...  
Keyword(s):  
Physical Activity ◽  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Breast Milk ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Lifestyle Interventions ◽  
Perinatal Complications ◽  
National Implementation ◽  
Randomised Controlled

IntroductionPericonception obesity is associated with a higher risk for adverse perinatal outcomes such as gestational diabetes mellitus, preeclampsia, large for gestational age, operative delivery and preterm birth. Lifestyle interventions during pregnancy have resulted in insufficient effects on reducing these perinatal complications. A few reasons for this disappointing effect can be suggested: (1) the time period during pregnancy for improvement of developmental circumstances is too short; (2) the periconception period in which complications originate is not included; and (3) lifestyle interventions may not have been sufficiently multidisciplinary and customised. A preconception lifestyle intervention might be more effective to reduce perinatal complications. Therefore, the aim of the Towards Prepared mums study is to evaluate the effect of a lifestyle intervention starting prior to conception on lifestyle behaviour change.Methods and analysisThis protocol outlines a non-blinded, randomised controlled trial. One hundred and twelve women (18–40 years of age) with overweight or obesity (body mass index≥25.0 kg/m2) who plan to conceive within 1 year will be randomised to either the intervention or care as usual group. The intervention group will receive a multidisciplinary, customised lifestyle intervention stimulating physical activity, a healthy diet and smoking cessation, if applicable. The lifestyle intervention and monitoring will take place until 12 months postpartum. The primary outcome is difference in weight in kg from baseline to 6 weeks postpartum. Secondary outcomes are gestational weight gain, postpartum weight retention, smoking cessation, dietary and physical activity habits. Furthermore, exploratory outcomes include body composition, cardiometabolic alterations, time to pregnancy, need for assisted reproductive technologies, perinatal complications of mother and child, and lung function of the child. Vaginal and oral swabs, samples of faeces, breast milk, placenta and cord blood will be stored for evaluation of microbial flora, epigenetic markers and breast milk composition. Furthermore, a cost-effectiveness analysis will take place.Ethics and disseminationEthical approval was obtained from the Medical Ethical Committee of Maastricht University Medical Centre+ (NL52452.068.15/METC152026). Knowledge derived from this study will be made available by publications in international peer-reviewed scientific journals and will be presented at (inter)national scientific conferences. A dissemination plan for regional and national implementation of the intervention is developed.Trial registration numberClinicalTrials.gov NCT02703753.

scholarly journals Physical activity for smoking cessation in pregnancy: randomised controlled trial

BMJ ◽  
2015 ◽  
Vol 350 (may14 16) ◽  
pp. h2145-h2145 ◽  
Author(s):  
M. Ussher ◽  
S. Lewis ◽  
P. Aveyard ◽  
I. Manyonda ◽  
R. West ◽  
...  
Keyword(s):  
Physical Activity ◽  
Smoking Cessation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled ◽  
In Pregnancy

scholarly journals Telehealth versus self-directed lifestyle intervention to promote healthy blood pressure: a protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e044292
Author(s):  
Mohamed Taher ◽  
Christina Yule ◽  
Heather Bonaparte ◽  
Sara Kwiecien ◽  
Charlotte Collins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Blood Pressure ◽  
Randomised Controlled Trial ◽  
Lifestyle Intervention ◽  
Healthy Eating ◽  
Controlled Trial ◽  
Healthy Eating Index ◽  
Dietary Quality ◽  
Web Based ◽  
Randomised Controlled

IntroductionWeight loss, consumption of a Dietary Approaches to Stop Hypertension dietary pattern, reduced sodium intake and increased physical activity have been shown to lower blood pressure (BP). Use of web-based tools and telehealth to deliver lifestyle counselling could be potentially scalable solutions to improve BP through behavioural modification though limited data exists to support these approaches in clinical practice.Methods and analysisThis randomised controlled trial will compare the efficacy of a telehealth versus self-directed lifestyle intervention in lowering 24-hour SBP in patients with overweight/obesity (body mass index ≥25 kg/m2) and 24-hour SBP 120–160 mm Hg. All participants receive personalised recommendations to improve dietary quality based on a web-based Food Frequency Questionnaire, access to an online comprehensive weight management programme and a smartphone dietary app. The telehealth arm additionally includes weekly calls with registered dietitian nutritionists who use motivational interviewing. The primary outcome is change from baseline to 12 weeks in 24-hour SBP. Secondary outcomes include changes from baseline in 24-hour diastolic BP, daytime SBP, nighttime SP, daytime diastolic BP, nighttime diastolic BP, total Healthy Eating Index-2015 score, weight, waist circumference and physical activity. Other prespecified outcomes will include change in individual components of the Healthy Eating Index-2015 score, and satisfaction with the Healthy BP research study measured on a 5-point Likert scale.Ethics and disseminationThe study has been approved by the Geisinger Institutional Review Board. Results will be disseminated through peer-reviewed publications and conference presentations.Trial registration numberNCT03700710.

scholarly journals Follow Your Virtual Trainer (FYVT): a randomised controlled trial protocol of IT-based lifestyle intervention programme to promote physical activity and health among middle-aged Hong Kong Chinese

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e017908 ◽  
Author(s):  
Stanley Sai-Chuen Hui ◽  
Yao Jie Xie ◽  
Ron Chi-Wai Kwok ◽  
Eric Wing-Cheung Tam ◽  
Winnie Wing Sze Mak ◽  
...  
Keyword(s):  
Physical Activity ◽  
Hong Kong ◽  
Randomised Controlled Trial ◽  
Lifestyle Intervention ◽  
Controlled Trial ◽  
Control Group ◽  
Middle Aged ◽  
Intervention Programme ◽  
Study Results ◽  
Randomised Controlled

IntroductionHong Kong is a highly urbanised city where many people work long hours. The limited time and lack of professional instruction are the typical barriers to exercise. The purpose of this study is to test the effectiveness of an information technology-based lifestyle intervention programme on improving physical activity (PA) level and health status in a sample of middle-aged Hong Kong adults.Methods and analysisA two-arm parallel randomised controlled trial named ‘Follow Your Virtual Trainer’ will be conducted among 200 physically inactive Chinese adults aged from 40 to 65 years. Those randomly allocated to an intervention group will be under the instruction of a web-based computer software termed ‘Virtual Trainer (VT)’ to conduct a 3-month self-planned PA programme. A series of online seminars with healthy lifestyle information will be released to the participants biweekly for 3 months. After that, 6 months observation will follow. Those in the control group will only receive a written advice of standard PA recommendation and the textual content of the seminars. The assessments will be implemented at baseline, the 3rd, 6th and 9th months. The primary outcome is PA measured by accelerometer and International Physical Activity Questionnaire. The secondary outcomes include cardiorespiratory fitness, resting energy expenditure, anthropometrics, body composition, blood pressure, health-related quality of life, sleep quality and quantity, fatigue, behaviour mediators and maintenance of PA. The main effectiveness of the intervention will be assessed by a linear mixed model that tests the random effect of treatment on outcomes at the 3rd, 6th and 9th months.Ethics and disseminationThis trial has been approved by the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (CRE 2015235). The study results will be presented at scientific conferences and published in peer-reviewed journals.Trial registration numberNCT02553980.

scholarly journals Improving Depressive Symptoms through Personalised Exercise and Activation (IDEA): Study Protocol for a Randomised Controlled Trial

2021 ◽  
Vol 18 (12) ◽  
pp. 6306
Author(s):  
Aitana García-Estela ◽  
Natalia Angarita-Osorio ◽  
Sandra Alonso ◽  
Maria Polo ◽  
Maria Roldán-Berengué ◽  
...  
Keyword(s):  
Physical Activity ◽  
Depressive Symptoms ◽  
Randomised Controlled Trial ◽  
Physical Health ◽  
Controlled Trial ◽  
Exercise Group ◽  
Global Functioning ◽  
Motivational Messages ◽  
Randomised Controlled ◽  
Group Programme

Individuals who suffer from depressive symptoms experience a substantial impact on psychosocial functioning, physical health, mortality, and quality of life. In the search for therapeutic strategies, exercise has been found to play a relevant part in its treatment. However, the promotion of exercise entails adherence difficulties that arose out of the tendency towards sedentarism led by symptomatology. Personalised exercise plans on top of usual care have the potential to enhance behavioural changes and mental health. The present study aims at evaluating the changes in functioning deriving from a blended intervention merging a psychological intervention with a personalised exercise programme based on medical assessment. We will conduct a three-arm randomised controlled trial in which 172 participants suffering from mild–moderate depressive symptoms will be allocated to Intervention A (personalised exercise group programme + app with motivational messages), B (personalised exercise group programme + app with no motivational messages) or control group (app with no motivational messages). Data regarding global functioning, well-being, symptoms, physical activity, and exercise capacity will be collected at baseline, 4, 12, and 36 weeks. The results of this trial will provide information about whether this physical activity support programme may be efficient for improving mental and physical health outcomes. Trial registration: ClinicalTrials.gov NCT04857944 (accessed on 15 April 2021). Registered April 2021.

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