First effective mHealth nutrition and lifestyle coaching program for subfertile couples undergoing in vitro fertilization treatment: a single-blinded multicenter randomized controlled trial.

OBJECTIVE: To study compliance and effectiveness of the mHealth nutrition and lifestyle coaching program Smarter Pregnancy in couples undergoing in vitro fertilization (IVF) treatment with or without intracytoplasmic sperm injection (ICSI). DESIGN: Multicenter, single-blinded, randomized controlled trial, conducted from July 2014 to March 2017. SETTING: IVF clinics. PATIENT(S): A total of 626 women undergoing IVF treatment with or without ICSI and 222 male partners. INTERVENTIONS(S): Couples were randomly assigned to the light (control group) or regular (intervention group) Smarter Pregnancy program. Both groups filled out a baseline screening questionnaire on nutrition and lifestyle behaviors, and the intervention group received coaching tailored to inadequate behaviors during the 24-week period. MAIN OUTCOME MEASURE(S): Difference in improvement of a composite dietary and lifestyle risk score for the intake of vegetables, fruits, folic acid supplements, smoking, and alcohol use after 24 weeks of the program. RESULT(S): Compared with control subjects, women and men in the intervention group showed a significantly larger improvement of inadequate nutrition behaviors after 24 weeks of coaching. At the same time, the women also showed a significantly larger improvement of inadequate lifestyle behaviors. CONCLUSION(S): The mHealth coaching program Smarter Pregnancy is effective and improves the most important nutritional and lifestyle behaviors among couples undergoing IVF/ICSI treatment. International multicenter randomized trials are recommended to study the effect of using Smarter Pregnancy on pregnancy, live birth, and neonatal outcome. NETHERLANDS TRIAL REGISTER NUMBER: NTR4150.

A Mobile App Lifestyle Intervention to Improve Healthy Nutrition in Women Before and During Early Pregnancy: Single-Center Randomized Controlled Trial.

BACKGROUND: Unhealthy nutrition contributes to the worldwide rising prevalence of noncommunicable diseases. As most adverse reproductive outcomes originate during the periconception period, effective interventions targeting this period are needed. Therefore, we developed the lifestyle intervention Smarter Pregnancy to empower women to adapt a healthy diet prior to conception and during early pregnancy and performed a randomized controlled trial. OBJECTIVE: The objectives of this trial were to investigate compliance and effectiveness in women using the Smarter Pregnancy program. METHODS: Women aged between 18 and 45 years who were contemplating pregnancy or <13 weeks pregnant and their male partners living in the urban area of Rotterdam, the Netherlands, were eligible for participation. After baseline screening, the intervention group received personal online coaching based on identified inadequate intakes of vegetables, fruits, and folic acid supplements. The sum of these risk factors was used as a dietary risk score (DRS), ranging from 0 (healthy) to 9 (unhealthy). The control group did not receive coaching. We applied an intention-to-treat principle and used a multivariable linear regression model to evaluate the change in DRS after 24 weeks. Compliance was defined as the percentage of women who completed the screening questionnaire at 24 weeks. RESULTS: Of women recruited, 81.2% (177/218) completed the program (intervention: 91/218, 83.5%; control: 86/218, 78.9%; P=.95). After 24 weeks, the reduction in DRS of women in the intervention group was significantly larger than in the control group (ß=.75, 95% CI 0.18-1.34). This reduction was mainly due to increased vegetable intake (ß=.55, 95% CI 0.25-0.86). CONCLUSIONS: The high compliance and the larger improvements in nutritional behaviors, especially vegetable intake, in women in the intervention group emphasizes the effectiveness of empowering women by using the lifestyle change intervention Smarter Pregnancy. TRIAL REGISTRATION: Netherlands Trial Register: NL3927; https://www.trialregister.nl/trial/3927. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s12884-017-1228-5.

Potential benefits of the use of sympathomimetics for asthmatic disease, on semen quality in men of subfertile couples.

RESEARCH QUESTION: Is there an association between the use of sympathomimetics for asthmatic disease and semen quality in humans? DESIGN: Between 2007 and 2012 a prospective cohort study was conducted among couples visiting the preconception counselling clinic at a tertiary hospital in the Netherlands. The study included 882 men of subfertile couples and information on medication use was obtained from self-administered questionnaires. Moreover, data on semen parameters were retrieved from medical records. RESULTS: The study population of men revealed a mean (± SD) age of 34 ± 4 years with a mean body mass index (BMI) of 26.1 ± 2.3 kg/m2, and sympathomimetic use was reported by 3.6%. The use of sympathomimetics was positively associated with a 10% higher sperm motility (beta 10.265; 95% confidence interval [CI] 3.258-17.272) after adjustment for smoking, alcohol use, age, geographic background, BMI, folic acid supplement use, the four astronomical seasons and asthma/bronchitis. Subgroup analysis between men with total motile sperm count (TMSC) < or ≥10 million showed that this association remained (P ≤ 0.001) after adjustment for these confounders. After adjustment for confounders the sperm concentration was also positively associated with the use of sympathomimetics, but only in men with TMSC ≥10 million (beta 0.300; 95% CI 0.032-0.568). CONCLUSIONS: These preliminary data show the potential benefits of the use of sympathomimetics to improve sperm motility in men of subfertile couples, which needs further investigation.

Mobile Health Coaching on Nutrition and Lifestyle Behaviors for Subfertile Couples Using the Smarter Pregnancy Program: Model-Based Cost-Effectiveness Analysis.

BACKGROUND: The health care costs for reproductive care have substantially increased with the use of in vitro fertilization (IVF) treatment. The mobile health (mHealth) coaching program Smarter Pregnancy is an effective intervention to improve nutrition and lifestyle behaviors and pregnancy rates in (sub)fertile couples, including those who undergo IVF treatment. Therefore, we hypothesize that this mHealth program can also reduce health care costs associated with IVF treatment. OBJECTIVE: This study aimed to evaluate the cost-effectiveness of the mHealth coaching program Smarter Pregnancy and compare it to usual care in women of subfertile couples who start their first IVF cycle. METHODS: This model-based cost-effectiveness analysis was performed on data from couples undergoing IVF treatment at the Erasmus MC, University Medical Center Rotterdam. A decision tree model was used to assess the incremental cost-effectiveness ratio (ICER) of ongoing pregnancies and costs of use of the mHealth program as compared to usual care. A probabilistic sensitivity analysis was performed to consider the uncertainty surrounding the point estimates of the input parameters. RESULTS: Based on our model including 793 subfertile women undergoing IVF treatment, use of the mHealth program resulted in 86 additional pregnancies and saved €270,000 compared to usual care after two IVF cycles, with an ICER of -€3050 (95% CI -3960 to -540) per additional pregnancy. The largest cost saving was caused by the avoided IVF treatment costs. Sensitivity analyses showed that the mHealth program needs to increase the ongoing pregnancy rate by at least 51% after two IVF cycles for cost saving. CONCLUSIONS: The mHealth coaching program Smarter Pregnancy is potentially cost saving for subfertile couples preceding their first IVF treatment. Implementation of this mHealth program in routine preconception care for subfertile couples should be seriously considered, given the relatively low costs and promising cost-effectiveness estimates.

No independent associations between preconception paternal dietary patterns and embryonic growth; the Predict Study.

BACKGROUND & AIM: Several studies show the importance of periconceptional maternal dietary patterns on human embryonic growth. Healthy paternal nutrition has been associated with better semen quality and fecundability, however, evidence on the impact on pregnancy outcome is limited. Therefore, the aim of this study was to investigate the association between preconception paternal dietary patterns and first trimester embryonic growth using the parameters longitudinal crown-rump length (CRL) and embryonic volume (EV). METHODS: A total of 638 couples were enrolled in the Rotterdam Periconceptional Cohort and received longitudinal three dimensional transvaginal ultrasound scans from 7+0 up to 12+0 weeks of gestation. Virtual reality software was used to perform offline measurements of the embryonic CRL and EV. Food frequency questionnaires (FFQ) were used to estimate habitual food intake in couples. Principal component analysis (PCA) was performed to identify paternal and maternal dietary patterns. Linear mixed models adjusted for potential confounders were applied to analyze associations between paternal and maternal dietary patterns and embryonic growth parameters. RESULTS: The paternal dietary patterns retrieved were identified as "Whole wheat grains and Vegetables", "Sauces and Snacks Refined Grains", "Fish and Legumes" and explained 27.5% of the total variance of the dietary intake. No significant additional effects, independent of maternal dietary patters and other maternal and paternal potential confounders, were shown of these paternal dietary patterns on embryonic growth in spontaneous or IVF/ICSI pregnancies. CONCLUSION: No significant effects of paternal dietary patterns independent of maternal dietary patters and other parental potential confounders on embryonic growth parameters could be established in spontaneous or IVF/ICSI pregnancies. The biological importance of paternal nutrition on semen quality, however, supports the need of periconceptional tailored nutritional counselling of couples trying to conceive.

The impact of maternal lifestyle factors on periconception outcomes: a systematic review of observational studies.

The main risk factors for important reproductive health issues such as subfertility and perinatal mortality largely originate in the periconception period. To evaluate associations between modifiable maternal lifestyle factors and periconception outcomes, a systematic search was conducted for relevant studies published from 1990 to February 2017 on Embase, Medline, Web of Science, Cochrane database, PubMed and Google Scholar. The initial search identified 6166 articles, of which 49 studies were eligible for inclusion. Fecundity (the capacity to have a live birth) showed significant inverse associations with smoking, alcohol use and poor diet. Studies regarding time to pregnancy showed a decline in fecundity ratios (the monthly conception rate among exposed relative to unexposed couples) with increasing body mass index (BMI). Furthermore, risk of first-trimester miscarriage was found to be increased in smokers, alcohol and caffeine consumers, and with increasing BMI. Vitamin supplement use showed a decrease in this risk. This review demonstrates that maternal modifiable lifestyle factors affect periconception outcomes. If couples planning a pregnancy are more aware and supported to adopt healthy lifestyles during the periconceptional 'window of opportunity', short-term reproductive health as well as health in later life and even of future generations can be further improved.

Strong adherence to a healthy dietary pattern is associated with better semen quality, especially in men with poor semen quality.

OBJECTIVE: To study associations between periconceptional dietary patterns and semen quality parameters. DESIGN: Prospective periconception cohort study. SETTING: Tertiary hospital. PATIENT(S): One hundred and twenty-nine male partners of pregnant women who participated in the Rotterdam Periconception Cohort (Predict study). INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Semen quality parameters-ejaculate volume, sperm concentration, total sperm count, progressive motility, immotile sperm, and total motile sperm count (TMSC). RESULT(S): Men included in our study were on average 35 (±6 standard deviation) years old and had a body mass index of 26.4 ± 4 kg/m2. Two dietary patterns were identified using principle component analysis, which were labeled as "healthy" and "unhealthy." An increase of one factor score (stated as ß) represented an increase of 1 standard deviation. Sperm concentration (ß = 0.278; 95% CI, 0.112-0.444), total sperm count (ß = 1.369; 95% CI, 0.244-2.495), progressive motility (ß = 4.305; 95% CI, 0.675-7.936), and TMSC (ß = 0.319; 95% CI, 0.113-0.526) were all positively associated with a strong adherence to the healthy dietary pattern. Subgroup analysis showed that these associations were mainly present in men with a TMSC <10 million spermatozoa. Although there was a trend toward a diminution in semen quality, we found no statistically significant associations with strong adherence to the unhealthy dietary pattern. CONCLUSION(S): The positive associations between strong adherence to a healthy dietary pattern and semen parameters in men with poor semen quality support the importance of preconceptional tailored nutritional counseling and coaching of couples who are trying to conceive.

The use of the mHealth program Smarter Pregnancy in preconception care: rationale, study design and data collection of a randomized controlled trial.

BACKGROUND: Unhealthy nutrition and lifestyle contribute to the worldwide rising prevalence of non-communicable diseases. This also accounts for the reproductive population, in which unhealthy behavior affects fertility and pregnancy outcome. Maternal smoking, alcohol consumption and inadequate folic acid supplement use are strongly associated with fetal complications as small for gestational age, premature birth and congenital malformations. In the Netherlands 83% of the perinatal mortality rate is due to these complications and is relatively high compared to other European countries. In order to reduce this prevalence rate, preconception care should be focused on the promotion of health of prospective parents by identification and intervention on modifiable nutrition and lifestyle risk factors. We developed the personal mHealth program 'Smarter Pregnancy' (Dutch version available on: https://www.slimmerzwanger.nl ) to provide individual coaching and information to improve nutrition and lifestyle during the preconception period in order to improve health of the reproductive population and subsequent generations. METHODS: Women between 18 and 45 years of age, and trying to conceive are eligible for inclusion in a randomized controlled trial. Participants are allocated either to a general population cohort or a subfertile (IVF/ICSI) population cohort. The intervention group receives personal online coaching based on the identified nutrition and lifestyle risk factors at baseline. Coaching comprises recipes, incentives, additional questions including feedback and text and e-mail messages, with a maximum of three per week. The control group only receives one recipe per week to maintain adherence to the program and prevent drop out. Screening questionnaires are send in both groups at 6, 12, 18, and 24 weeks of the program to monitor the change in the identified risk factors. DISCUSSION: We expect to demonstrate that the mHealth program 'Smarter Pregnancy' can effectively improve nutrition and lifestyle in couples contemplating pregnancy. By the identification and improvement of modifiable nutrition and lifestyle risk factors on a large scale, both reproductive and pregnancy outcomes can be improved and subsequent perinatal morbidity and mortality rates are expected to be reduced. The current use and rapid development of mHealth applications offers new opportunities to reach and educate large populations, which can facilitate the implementation of preconception care. TRIAL REGISTRATION: Dutch trial register: NTR4150 . (Registered 19th August 2013).