scholarly journals Effectiveness of a digital health intervention with a smartband and counselling App in gestational weight gain and physical activity in pregnant women with obesity (PAS & PES study): a randomised controlled trial (Preprint)

2021 ◽  
Author(s):  
Elena Gonzalez-Plaza ◽  
Jordi Bellart ◽  
Ángela Arranz ◽  
Leila Luján-Barroso ◽  
Esther Crespo ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Gain ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Mobile Apps ◽  
Controlled Trial ◽  
Perinatal Outcomes ◽  
Gestational Weight ◽  
Randomised Controlled ◽  
Health Counselling

BACKGROUND Obesity during pregnancy is a public health problem in our society. Pregnant women with obesity with excessive gestational weight gain (GWG) present a higher probability of presenting maternal and perinatal complications. The use of mobile Apps and a wristband during pregnancy may contribute to promoting healthy lifestyles and, thus, improving maternal and neonatal health. OBJECTIVE The objectives were to evaluate the effectiveness of the use of a smartband and an App with health counselling together with virtual support from a midwife in relation to GWG and physical activity (PA) in pregnant women with pre-pregnancy obesity and analyse the impact on maternal and perinatal outcomes. In addition, we studied the frequency of use, usability and satisfaction with the mobile Apps used by the women in the intervention group (IG). METHODS This parallel 2-arm randomised controlled trial included 150 pregnant women with obesity. The IG received a complex combined digital intervention called Pas & Pes. The intervention was delivered with a smartband (Mi band 2©) linked to the App Mi Fit© plus personalised health information and 24h/day midwife support through another App (Hangouts ©). Women in the control group (CG) only received standard antenatal care. The Spanish version of the International Physical Activity Questionnaire Short Form (IPAQ-SF) and the System Usability Scale (SUS) were used. Satisfaction was measured in a 1-5 point Likert scale. RESULTS We analysed 120 pregnant women; 30 have been withdrawn due to the COVID-19 pandemic. The mean GWG in the IG was 7 kg (Q1=4-Q3=11) vs. 9.3 kg (Q1=5.9-Q3=3.3) in the CG, P=.04. At the end of the study, the adjusted mean weight gain per week was 0.500 kg/week (95% confidence interval [CI]: 0.41 to 0.58) for the CG and 0.350 kg/week (95%CI: 0.27-0.43) for the IG.Between gestation weeks 35-37, the women in the IG performed greater mean PA than the GC (1,980 metabolic equivalent of tasks [METs]-min/week vs. 1,386 METs/min-week, respectively; P=.01). No differences were observed between study groups in the incidence of maternal and perinatal outcomes. In the IG, 61% (36) of the pregnant women used the smartband daily, and 74.6% (44) evaluated the usability of the Mi Fit© App as excellent. The grade of satisfaction with the health counselling and virtual midwife support through an App obtained a mean score of 4.8 (SD: 0.6) points. CONCLUSIONS The use of a smartband and a health counselling App together with virtual midwife support and standard prenatal controls were effective for obtaining a lower GWG and increasing the performance of PA in pregnant women with obesity. CLINICALTRIAL This trial was registered in the Clinical Trial Register of the National Library of Medicine of United States (NCT03706872).

scholarly journals Intake of Sweets, Snacks and Soft Drinks Predicts Weight Gain in Obese Pregnant Women: Detailed Analysis of the Results of a Randomised Controlled Trial

PLoS ONE ◽  
2015 ◽  
Vol 10 (7) ◽  
pp. e0133041 ◽  
Author(s):  
Kristina M. Renault ◽  
Emma M. Carlsen ◽  
Kirsten Nørgaard ◽  
Lisbeth Nilas ◽  
Ole Pryds ◽  
...  
Keyword(s):  
Weight Gain ◽  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Detailed Analysis ◽  
Controlled Trial ◽  
Soft Drinks ◽  
Randomised Controlled

scholarly journals Individually Tailored, Adaptive Intervention to Manage Gestational Weight Gain: Protocol for a Randomized Controlled Trial in Women With Overweight and Obesity (Preprint)

2017 ◽  
Author(s):  
Danielle Symons Downs ◽  
Jennifer S Savage ◽  
Daniel E Rivera ◽  
Joshua M Smyth ◽  
Barbara J Rolls ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Weight Gain ◽  
Pregnant Women ◽  
Healthy Eating ◽  
Controlled Trial ◽  
Overweight And Obesity ◽  
Adaptive Intervention ◽  
Gestational Weight ◽  
Randomized Controlled

BACKGROUND High gestational weight gain is a major public health concern as it independently predicts adverse maternal and infant outcomes. Past interventions have had only limited success in effectively managing pregnancy weight gain, especially among women with overweight and obesity. Well-designed interventions are needed that take an individualized approach and target unique barriers to promote healthy weight gain. OBJECTIVE The primary aim of the study is to describe the study protocol for Healthy Mom Zone, an individually tailored, adaptive intervention for managing weight in pregnant women with overweight and obesity. METHODS The Healthy Mom Zone Intervention, based on theories of planned behavior and self-regulation and a model of energy balance, includes components (eg, education, self-monitoring, physical activity/healthy eating behaviors) that are adapted over the intervention (ie, increase in intensity) to better regulate weight gain. Decision rules inform when to adapt the intervention. In this randomized controlled trial, women are randomized to the intervention or standard care control group. The intervention is delivered from approximately 8-36 weeks gestation and includes step-ups in dosages (ie, Step-up 1 = education + physical activity + healthy eating active learning [cooking/recipes]; Step-up 2 = Step-up 1 + portion size, physical activity; Step-up 3 = Step-up 1 + 2 + grocery store feedback, physical activity); 5 maximum adaptations. Study measures are obtained at pre- and postintervention as well as daily (eg, weight), weekly (eg, energy intake/expenditure), and monthly (eg, psychological) over the study period. Analyses will include linear mixed-effects models, generalized estimating equations, and dynamical modeling to understand between-group and within-individual effects of the intervention on weight gain. RESULTS Recruitment of 31 pregnant women with overweight and obesity has occurred from January 2016 through July 2017. Baseline data have been collected for all participants. To date, 24 participants have completed the intervention and postintervention follow-up assessments, 3 are currently in progress, 1 dropped out, and 3 women had early miscarriages and are no longer active in the study. Of the 24 participants, 13 women have completed the intervention to date, of which 1 (8%, 1/13) received only the baseline intervention, 3 (23%, 3/13) received baseline + step-up 1, 6 (46%, 6/13) received baseline + step-up 1 + step-up 2, and 3 (23%, 3/13) received baseline + step-up 1 + step-up 2 +step-up 3. Data analysis is still ongoing through spring 2018. CONCLUSIONS This is one of the first intervention studies to use an individually tailored, adaptive design to manage weight gain in pregnancy. Results from this study will be useful in designing a larger randomized trial to examine efficacy of this intervention and developing strategies for clinical application. REGISTERED REPORT IDENTIFIER RR1-10.2196/9220

scholarly journals Effectiveness of a behavioural intervention involving regular weighing and feedback by community midwives within routine antenatal care to prevent excessive gestational weight gain: POPS2 randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (9) ◽  
pp. e030174 ◽  
Author(s):  
Amanda Daley ◽  
Kate Jolly ◽  
Susan A Jebb ◽  
Andrea Roalfe ◽  
Lucy Mackilllop ◽  
...  
Keyword(s):  
Physical Activity ◽  
Weight Gain ◽  
Gestational Weight Gain ◽  
Controlled Trial ◽  
Behavioural Intervention ◽  
Maximum Weight ◽  
Gestational Weight ◽  
Excessive Gestational Weight Gain ◽  
Community Midwives ◽  
Randomised Controlled

ObjectivesTo assess the effectiveness of a brief behavioural intervention based on routine antenatal weighing to prevent excessive gestational weight gain (defined by US Institute of Medicine).DesignRandomised controlled trial.SettingAntenatal clinic in England.ParticipantsWomen between 10+0and 14+6weeks gestation, not requiring specialist obstetric care.InterventionsParticipants were randomised to usual antenatal care or usual care (UC) plus the intervention. The intervention involved community midwives weighing women at antenatal appointments, setting maximum weight gain limits between appointments and providing brief feedback. Women were encouraged to monitor and record their own weight weekly to assess their progress against the maximum limits set by their midwife. The comparator was usual maternity care.Primary and secondary outcome measuresExcessive gestational weight gain, depression, anxiety and physical activity.ResultsSix hundred and fifty-six women from four maternity centres were recruited: 329 women were randomised to the intervention group and 327 to UC. We found no evidence that the intervention decreased excessive gestational weight gain. At 38 weeks gestation, the proportions gaining excessive gestational weight were 27.6% (81/305) versus 28.9% (90/311) (adjusted OR 0.84, 95% CI: 0.53 to 1.33) in the intervention and UC group, respectively. There were no significant difference between the groups in anxiety or depression scores (anxiety: adjusted mean −0.58, 95% CI:−1.25 to –0.8; depression: adjusted mean −0.60, 95% CI:−1.24 to –0.05). There were no significant differences in physical activity scores between the groups.ConclusionsA behavioural intervention delivered by community midwives involving routine weighing throughout pregnancy, setting maximum weight gain targets and encouraging women to weigh themselves each week to check progress did not prevent excessive gestational weight gain. There was no evidence of psychological harm.Trial registration numberISRCTN67427351

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