scholarly journals Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Sharleen L. O’Reilly ◽  
Christy Burden ◽  
Cristina Campoy ◽  
Fionnuala M. McAuliffe ◽  
Helena Teede ◽  
...  
Keyword(s):  
Weight Gain ◽  
High Risk ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Early Pregnancy ◽  
Evidence Based ◽  
Non Communicable Diseases ◽  
Gestational Weight ◽  
Pregnancy And Postpartum ◽  
In Pregnancy

Abstract Background Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM. Methods Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks’ gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m2 at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received. Discussion Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation. Trial registration Australian New Zealand Clinical Trials Registry ACTRN12620001240932. Registered on 19 November 2020

Rationale, design, and challenges with implementing a clinical intervention to teach appropriate gestational weight gain (TAGG): Protocol of a Randomized controlled trial (Preprint)

2019 ◽  
Author(s):  
Awathif Mackeen ◽  
Danielle Downs ◽  
Vonda Hetherington ◽  
Shawnee Lutcher ◽  
Jacob Mowery ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Usual Care ◽  
Gestational Weight Gain ◽  
Perceived Stress ◽  
Controlled Trial ◽  
Household Food Security ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND Excessive gestational weight gain (GWG) has public health implications including preterm birth, preeclampsia, gestational diabetes, and cesarean delivery. In an effort to mitigate adverse consequences of excessive GWG, this study tests a health intervention that includes enhancements to improve knowledge and awareness of appropriate GWG, and patient-centered nutritional counseling to promote appropriate GWG. OBJECTIVE The primary objective of the study was to increase the proportion of women who are managing their GWG as recommended by the IOM.4,5 METHODS This randomized controlled trial was conducted at Geisinger in Pennsylvania where excessive GWG is common among women with pre-conception obesity. Eligible, consenting participants with pre-pregnancy body mass index >30.0 kg/m2 were randomized (1:1) to: 1) Usual Care: usual written educational materials and counseling by an obstetric care provider or 2) Enhanced Care: Usual Care plus a) a personalized letter from a physician detailing appropriate GWG, b) exposure to individualized GWG chart in the electronic health record via the patient portal, and c) a consult with a Registered Dietitian Nutritionist and follow-up via tele-health counseling (10-20 mins/1-2 weeks) for the duration of the pregnancy. RESULTS The primary outcome was the proportion of women that gain less than 20 pounds over the course of the pregnancy. Secondary outcomes include knowledge, expectations, and attitude about pregnancy weight gain; increased self-efficacy for ability to eat healthy and being physically active to manage weight; and eating behavior. Potential moderators that will be explored include sleep, perceived stress, perceived involvement in care, and household food security. Data collection has been completed as of November 2019. CONCLUSIONS As GWG care was initiated for mothers with pre-pregnancy BMI >30 kg/m2 within the first and second trimesters, the intervention may have the additional benefit of reducing other adverse pregnancy outcomes including the incidence of gestational diabetes due to healthier rates of GWG. In addition to assessing appropriate GWG, this project will assess eating habits, physical activity, GWG attitudes, sleep quality, and psychological measures, all of which are associated with GWG. Exploratory mediators including perceived stress and food insecurity will also be evaluated. CLINICALTRIAL ClinicalTrials.gov NCT02963428

scholarly journals Lower education predicts poor response to dietary intervention in pregnancy, regardless of neighbourhood affluence: secondary analysis from the ROLO randomised control trial

2017 ◽  
Vol 20 (16) ◽  
pp. 2959-2969 ◽  
Author(s):  
Eileen C O’Brien ◽  
Goiuri Alberdi ◽  
Aisling A Geraghty ◽  
Fionnuala M McAuliffe
Keyword(s):  
Weight Gain ◽  
Gestational Weight Gain ◽  
Dietary Intervention ◽  
Randomised Control Trial ◽  
Control Group ◽  
Education Session ◽  
Neighbourhood Deprivation ◽  
Gestational Weight ◽  
Dietary Education ◽  
In Pregnancy

AbstractObjectiveTo determine if response to a low glycaemic index (GI) dietary intervention, measured by changes in dietary intake and gestational weight gain, differed across women of varying socio-economic status (SES).DesignSecondary data analysis of the ROLO randomised control trial. The intervention consisted of a two-hour low-GI dietary education session in early pregnancy. Change in GI was measured using 3 d food diaries pre- and post-intervention. Gestational weight gain was categorised as per the 2009 Institute of Medicine guidelines. SES was measured using education and neighbourhood deprivation.SettingThe National Maternity Hospital, Dublin, Ireland.SubjectsWomen (n 625) recruited to the ROLO randomised control trial.ResultsThe intervention significantly reduced GI and excess gestational weight gain (EGWG) among women with third level education residing in both disadvantaged (GI, mean (sd), intervention v. control: −3·30 (5·15) v. −0·32 (4·22), P=0·024; EGWG, n (%), intervention v. control: 7 (33·6) v. 22 (67·9); P=0·022) and advantaged areas (GI: −1·13 (3·88) v. 0·06 (3·75), P=0·020; EGWG: 41 (34·1) v. 58 (52·6); P=0·006). Neither GI nor gestational weight gain differed between the intervention and control group among women with less than third level education, regardless of neighbourhood deprivation.ConclusionsA single dietary education session was not effective in reducing GI or gestational weight gain among less educated women. Multifaceted, appropriate and practical approaches are required in pregnancy interventions to improve pregnancy outcomes for less educated women.

scholarly journals Cardiometabolic and mental health in women with early gestational diabetes mellitus: A prospective cohort study

2021 ◽  
Author(s):  
Dan Yedu Quansah ◽  
Justine Gross ◽  
Leah Gilbert ◽  
Amelie Pauchet ◽  
Antje Horsch ◽  
...  
Keyword(s):  
Mental Health ◽  
Risk Factors ◽  
Weight Gain ◽  
Gestational Diabetes ◽  
Gestational Weight Gain ◽  
Gestational Age ◽  
Prospective Cohort ◽  
Gestational Weight ◽  
Pregnancy And Postpartum ◽  
History Of

Abstract Context Early diagnosis and treatment of gestational diabetes (GDM) may reduce adverse obstetric and neonatal outcomes, especially in high-risk women. However, there is a lack of data for other outcomes. Objective We compared cardiometabolic and mental health outcomes in women with early (eGDM) and classical (cGDM) GDM. Methods This prospective cohort included 1185 women with cGDM and 76 women with eGDM. eGDM had GDM-risk factors (BMI >30kg/m 2, family history of diabetes, history of GDM, ethnicity), were tested at <20 weeks gestational age and diagnosed using ADA prediabetes criteria. Women underwent lifestyle adaptations. Obstetric, neonatal, mental, cardiometabolic outcomes were assessed during pregnancy and postpartum. Results eGDM had lower gestational weight gain than cGDM (10.7±6.2 vs 12.6±6.4, p=0.03), but needed more medical treatment (66% vs 42%, p<0.001). They had similar rates of adverse maternal and neonatal outcomes, except for increased large-for-gestational-age infants (25% vs 15%, p=0.02). Mental health during pregnancy and postpartum did not differ between groups. eGDM had more atherogenic postpartum lipid profile than cGDM (p≤0.001). In eGDM, the postpartum prevalence of metabolic syndrome (MetS) was 1.8-times, prediabetes was 3.1-times and diabetes was 7.4-times higher than cGDM (MetS-waist circumference-based: 62% vs 34%/MetS-BMI-based: 46% vs 24%; prediabetes: 47.5% vs 15.3%; diabetes: 11.9% vs 1.6%, all p<0.001). These differences remained unchanged after adjusting for GDM-risk factors. Conclusion Compared to cGDM, eGDM was not associated with differences in mental health, but with increased adverse cardiometabolic outcomes, independent of GDM-risk factors and gestational weight gain. This hints to a pre-existing risk-profile in eGDM.

Antenatal body mass index (BMI) and weight gain in pregnancy – its association with pregnancy and birthing complications

2016 ◽  
Vol 44 (4) ◽  
Author(s):  
Josefine Theresia Maier ◽  
Elisabeth Schalinski ◽  
Ulrich Gauger ◽  
Lars Hellmeyer
Keyword(s):  
Weight Gain ◽  
Gestational Weight Gain ◽  
Overweight And Obesity ◽  
Labor Induction ◽  
Reproductive Age ◽  
Common Finding ◽  
Pregnancy Weight Gain ◽  
Gestational Weight ◽  
Pregnancy Weight ◽  
In Pregnancy

AbstractOverweight and obesity is a serious health risk in both developed and developing nations. It is a common finding among women in their reproductive age. Half of patients entering their pregnancy in the US have a BMI >25.0 and therefore qualify as overweight or obese. Moreover, there is a tendency towards increased weight gain during pregnancy. Studies have shown that gestational overweight is associated with complications in pregnancy and birthing as well as short-term and long-term impacts on neonatal outcome in childhood and adulthood.Five hundred and ninety-one women visiting our tertiary perinatal center in 2014 were analyzed for antenatal BMI, gestational weight gain, as well as pregnancy outcome and complication together with neonatal weight and outcome. Pregnancy weight gain was assessed based on the IOM guidelines (Institute of Medicine) issued in 2009.Twenty-nine percent of our population was overweight with a BMI of more than 25.0. The general weight gain was in every BMI group similar (median ranging from 12.0 to 14.0 kg). Approximately one third gained more than the appropriate amount (37%, P<0.001). Women with more gestational weight were at risk of labor induction (55.0% vs. 45.7% labor induction in total, P=0.007). Strikingly, those patients were found to have significantly higher rates of secondary cesarean section (22.4% vs. 15.4%) and decreased chances of spontaneous vaginal birth (57.5% vs. 61.4%) (P=0.008). Furthermore women with a pregnancy weight gain in excess of the guidelines gave birth to neonates with a higher birth weight (>75.centile, 28.3% vs. 21.3%, P<0.001).Altogether, one third of the analyzed population is already overweight or obese when entering pregnancy. A higher gestational weight gain than the recommended amount was found in 37% of cases. We found an association with pregnancy and birthing complications as well as higher infant weight. This highlights the importance of preconceptive and prenatal advice, and if necessary, intervention on BMI and weight gain.

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