Influence of a Concurrent Exercise Training Intervention during Pregnancy on Maternal and Arterial and Venous Cord Serum Cytokines: The GESTAFIT Project

The aim of the present study was to analyze the influence of a supervised concurrent exercise-training program, from the 17th gestational week until delivery, on cytokines in maternal (at 17th and 35th gestational week, and at delivery) and arterial and venous cord serum. Fifty-eight Caucasian pregnant women (age: 33.5 +/- 4.7 years old, body mass index: 23.6 +/- 4.1kg/m(2)) from the GESTAFIT Project (exercise (n = 37) and control (n = 21) groups) participated in this quasi-experimental study (per-protocol basis). The exercise group followed a 60-min 3 days/week concurrent (aerobic-resistance) exercise-training from the 17th gestational week to delivery. Maternal and arterial and venous cord serum cytokines (fractalkine, interleukin (IL)-1 beta, IL-6, IL-8, IL-10, interferon (IFN)-gamma, and tumor necrosis factor (TNF)-alpha) were assessed using Luminex xMAP technology. In maternal serum (after adjusting for the baseline values of cytokines), the exercise group decreased TNF-alpha (from baseline to 35th week, p = 0.02), and increased less IL-1 beta (from baseline to delivery, p = 0.03) concentrations than controls. When adjusting for other potential confounders, these differences became non-significant. In cord blood, the exercise group showed reduced arterial IL-6 and venous TNF-alpha (p = 0.03 and p = 0.001, respectively) and higher concentrations of arterial IL-1 beta (p = 0.03) compared to controls. The application of concurrent exercise-training programs could be a strategy to modulate immune responses in pregnant women and their fetuses. However, future research is needed to better understand the origin and clearance of these cytokines, their role in the maternal-placental-fetus crosstalk, and the influence of exercise interventions on them

A cognitive behavioural mHealth intervention for families in the postpartum period to enhance weight management, mental well-being and resilience : a study protocol for a randomised controlled trial (I‑PREGNO) : [version 1; peer review: awaiting peer review]

Introduction: The postpartum period goes along with an increased risk of unhealthy weight gain and numerous physical and psychological challenges, which are associated with mental well-being and resilience. Given the individual circumstances and the accompanying time constraints, evidence-based mHealth interventions may be useful for flexible, spot-on complementary care. Thus, the mHealth app I-PREGNO aims to enhance mental well-being and resilience by offering cognitive-behavioural and behaviour change skills training to prevent unhealthy weight development in this vulnerable life episode. In a randomised controlled trial, we will examine its effectiveness and acceptance. Protocol: Parents of infants between 0 and 12 months will be randomised to the intervention or control group. Both groups will take part in a baseline survey (t0) and further assessments after 12 weeks (intervention duration, t1), and 6 months (t2). The intervention group will use the self-guided mHealth app after t0 and both groups will get unlimited access after t2. The primary outcomes will be i) weight (difference of weight in kg after the intervention and pre-pregnancy); ii) mental well-being assessed through the Edinburgh-Postnatal-Depression-Scale and Parenting Stress Index; iii) resilience assessed through the General Self-Efficacy Scale and Difficulties in Emotion Regulation Scale. Secondary outcomes will be sociodemographic variables, eating behaviour, physical activity, relationship experiences, childhood trauma, postpartum bonding, regulatory disorders, and app usability. Gender differences between mothers and fathers will be considered. Conclusion: Positive effects on weight development in the postpartum period, mental well-being, and resilience due to the I-PREGNO intervention will support parental health in the critical postpartum phase. The study results will contribute to the growing field of evidence-based, highly scalable, low-cost, geographically independent, just-in-time mobile support for a target group that is restricted in time and resources. Trial registration: The trial has been registered at the German Clinical Trials Register (DRKS00031067) in January 2023 prospectively

I-PREGNO – prevention of unhealthy weight gain and psychosocial stress in families during pregnancy and postpartum using an mHealth enhanced intervention: a study protocol of two cluster randomized controlled trials

Background The transition to parenthood represents a critical life period with psychosocial, and behavioral changes and challenges for parents. This often increases stress and leads to unhealthy weight gain in families, especially in psychosocially burdened families. Although universal and selective prevention programs are offered to families, specific support often fails to reach psychosocially burdened families. Digital technologies are a chance to overcome this problem by enabling a low-threshold access for parents in need. However, there is currently a lack of smartphone-based interventions that are tailored to the needs of psychosocially burdened families. Aims The research project I-PREGNO aims to develop and evaluate a self-guided, smartphone-based intervention in combination with face-to-face counseling delivered by healthcare professionals for the prevention of unhealthy weight gain and psychosocial problems. The intervention is specifically tailored to the needs of psychosocially burdened families during the pregnancy and postpartum period. Methods In two cluster randomized controlled trials in Germany and Austria (N = 400) psychosocially burdened families will be recruited and randomized to i) treatment as usual (TAU), or ii) I-PREGNO intervention (self-guided I-PREGNO app with counseling sessions) and TAU. We expect higher acceptance and better outcomes on parental weight gain and psychosocial stress in the intervention group. Discussion The intervention offers a low cost and low-threshold intervention and considers the life situation of psychosocially burdened families who are a neglected group in traditional prevention programs. After positive evaluation, the intervention may easily be implemented in existing perinatal care structures in European countries such as Germany and Austria. Trial registration Both trials were registered prospectively at the German Clinical Trials Register (Germany: DRKS00029673; Austria: DRKS00029934) in July and August 2022

Effects of a preconception lifestyle intervention in obese infertile women on diet and physical activity; : A secondary analysis of a randomized controlled trial

Funding: The LIFEstyle study was funded by ZonMw, the Dutch Organization for Health Research and Development, grant number: 50- 50110-96-518. TvE is supported by grants from the Dutch Heart Foundation (2013T085) and the European Commission (Horizon2020 project 633595 DynaHealth). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscriptPeer reviewedPublisher PD

Cost-effectiveness of an exercise program during pregnancy to prevent gestational diabetes: Results of an economic evaluation alongside a randomised controlled trial

<p>Abstract</p> <p>Background</p> <p>The prevalence of gestational diabetes mellitus (GDM) is increasing worldwide. GDM and the risks associated with GDM lead to increased health care costs and losses in productivity. The objective of this study is to evaluate whether the FitFor2 exercise program during pregnancy is cost-effective from a societal perspective as compared to standard care.</p> <p>Methods</p> <p>A randomised controlled trial (RCT) and simultaneous economic evaluation of the FitFor2 program were conducted. Pregnant women at risk for GDM were randomised to an exercise program to prevent high maternal blood glucose (n = 62) or to standard care (n = 59). The exercise program consisted of two sessions of aerobic and strengthening exercises per week. Clinical outcome measures were maternal fasting blood glucose levels, insulin sensitivity and infant birth weight. Quality of life was measured using the EuroQol 5-D and quality-adjusted life-years (QALYs) were calculated. Resource utilization and sick leave data were collected by questionnaires. Data were analysed according to the intention-to-treat principle. Missing data were imputed using multiple imputations. Bootstrapping techniques estimated the uncertainty surrounding the cost differences and incremental cost-effectiveness ratios.</p> <p>Results</p> <p>There were no statistically significant differences in any outcome measure. During pregnancy, total health care costs and costs of productivity losses were statistically non-significant (mean difference €1308; 95%CI €-229 - €3204). The cost-effectiveness analyses showed that the exercise program was not cost-effective in comparison to the control group for blood glucose levels, insulin sensitivity, infant birth weight or QALYs.</p> <p>Conclusion</p> <p>The twice-weekly exercise program for pregnant women at risk for GDM evaluated in the present study was not cost-effective compared to standard care. Based on these results, implementation of this exercise program for the prevention of GDM cannot be recommended.</p> <p>Trial registration</p> <p>NTR1139</p

DALI:Vitamin D and lifestyle intervention for gestational diabetes mellitus (GDM) prevention: an European multicentre, randomised trial - study protocol

BACKGROUND: Gestational diabetes mellitus (GDM) is an increasing problem world-wide. Lifestyle interventions and/or vitamin D supplementation might help prevent GDM in some women. METHODS/DESIGN: Pregnant women at risk of GDM (BMI 65 29 (kg/m(2))) from 9 European countries will be invited to participate and consent obtained before 19+6 weeks of gestation. After giving informed consent, women without GDM will be included (based on IADPSG criteria: fasting glucose<5.1 mmol; 1 hour glucose <10.0 mmol; 2 hour glucose <8.5 mmol) and randomized to one of the 8 intervention arms using a 2 7 (2 7 2) factorial design: (1) healthy eating (HE), 2) physical activity (PA), 3) HE+PA, 4) control, 5) HE+PA+vitamin D, 6) HE+PA+placebo, 7) vitamin D alone, 8) placebo alone), pre-stratified for each site. In total, 880 women will be included with 110 women allocated to each arm. Between entry and 35 weeks of gestation, women allocated to a lifestyle intervention will receive 5 face-to-face, and 4 telephone coaching sessions, based on the principles of motivational interviewing. The lifestyle intervention includes a discussion about the risks of GDM, a weight gain target <5 kg and either 7 healthy eating 'messages' and/or 5 physical activity 'messages' depending on randomization. Fidelity is monitored by the use of a personal digital assistance (PDA) system. Participants randomized to the vitamin D intervention receive either 1600 IU vitamin D or placebo for daily intake until delivery. Data is collected at baseline measurement, at 24-28 weeks, 35-37 weeks of gestation and after delivery. Primary outcome measures are gestational weight gain, fasting glucose and insulin sensitivity, with a range of obstetric secondary outcome measures including birth weight. DISCUSSION: DALI is a unique Europe-wide randomised controlled trial, which will gain insight into preventive measures against the development of GDM in overweight and obese women

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes—individual patient data (IPD) meta-analysis and health economic evaluation

Abstract Background Pregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women. Methods/design Randomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage weight gain in pregnancy and undertake a value of information analysis to inform future research. Systematic review registration PROSPERO 2013: CRD4201300380

The effects of a controlled worksite environmental intervention on determinants of dietary behavior and self-reported fruit, vegetable and fat intake

BACKGROUND: Eating patterns in Western industrialized countries are characterized by a high energy intake and an overconsumption of (saturated) fat, cholesterol, sugar and salt. Many chronic diseases are associated with unhealthy eating patterns. On the other hand, a healthy diet (low saturated fat intake and high fruit and vegetable intake) has been found important in the prevention of health problems, such as cancer and cardio-vascular disease (CVD). The worksite seems an ideal intervention setting to influence dietary behavior. The purpose of this study is to present the effects of a worksite environmental intervention on fruit, vegetable and fat intake and determinants of behavior. METHODS: A controlled trial that included two different governmental companies (n = 515): one intervention and one control company. Outcome measurements (short-fat list and fruit and vegetable questionnaire) took place at baseline and 3 and 12 months after baseline. The relatively modest environmental intervention consisted of product information to facilitate healthier food choices (i.e., the caloric (kcal) value of foods in groups of products was translated into the number of minutes to perform a certain (occupational) activity to burn these calories). RESULTS: Significant changes in psychosocial determinants of dietary behavior were found; subjects at the intervention worksite perceived more social support from their colleagues in eating less fat. But also counter intuitive effects were found: at 12 months the attitude and self-efficacy towards eating less fat became less positive in the intervention group. No effects were found on self-reported fat, fruit and vegetable intake. CONCLUSION: This environmental intervention was modestly effective in changing behavioral determinant towards eating less fat (social support, self-efficacy and attitude), but ineffective in positively changing actual fat, fruit and vegetable intake of office workers

Study protocol: differential effects of diet and physical activity based interventions in pregnancy on maternal and fetal outcomes--individual patient data (IPD) meta-analysis and health economic evaluation.

© 2014 Ruifrok et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.BACKGROUND: Pregnant women who gain excess weight are at risk of complications during pregnancy and in the long term. Interventions based on diet and physical activity minimise gestational weight gain with varied effect on clinical outcomes. The effect of interventions on varied groups of women based on body mass index, age, ethnicity, socioeconomic status, parity, and underlying medical conditions is not clear. Our individual patient data (IPD) meta-analysis of randomised trials will assess the differential effect of diet- and physical activity-based interventions on maternal weight gain and pregnancy outcomes in clinically relevant subgroups of women. METHODS/DESIGN: Randomised trials on diet and physical activity in pregnancy will be identified by searching the following databases: MEDLINE, EMBASE, BIOSIS, LILACS, Pascal, Science Citation Index, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Database of Abstracts of Reviews of Effects, and Health Technology Assessment Database. Primary researchers of the identified trials are invited to join the International Weight Management in Pregnancy Collaborative Network and share their individual patient data. We will reanalyse each study separately and confirm the findings with the original authors. Then, for each intervention type and outcome, we will perform as appropriate either a one-step or a two-step IPD meta-analysis to obtain summary estimates of effects and 95% confidence intervals, for all women combined and for each subgroup of interest. The primary outcomes are gestational weight gain and composite adverse maternal and fetal outcomes. The difference in effects between subgroups will be estimated and between-study heterogeneity suitably quantified and explored. The potential for publication bias and availability bias in the IPD obtained will be investigated. We will conduct a model-based economic evaluation to assess the cost effectiveness of the interventions to manage weight gain in pregnancy and undertake a value of information analysis to inform future research. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 2013: CRD42013003804.This study was funded by the National Institute for Health Research (NIHR) HTA (Health Technology Assessment) UK programme 12/01