TY - JOUR
T1 - Optimising gestational weight gain and improving maternal and infant health outcomes through antenatal dietary, lifestyle and physical activity advice
T2 - The OPTIMISE randomised controlled trial protocol
AU - Dodd, Jodie M.
AU - Deussen, Andrea R.
AU - Louise, Jennie
N1 - Publisher Copyright:
© 2018 Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved.
PY - 2018/2/1
Y1 - 2018/2/1
N2 - Introduction Obesity represents a significant health burden, and WHO recognises the importance of preventing weight gain and subsequent development of obesity among adults who are within the healthy weight range. Women of reproductive age have demonstrated high rates of weight gain during pregnancy placing them at risk of becoming overweight or obese. We will evaluate the effects of dietary and physical activity advice on maternal, fetal and infant health outcomes, among pregnant women of normal body mass index (BMI). Methods and analysis We will conduct a randomised controlled trial, consenting and randomising women with a live singleton pregnancy between 10 +0 and 20 +0 weeks and BMI 18.5-24.9 kg/m 2 at first antenatal visit, from a tertiary maternity hospital. Women randomised to the Lifestyle Advice Group will receive three face-to-face sessions (two with a research dietitian and one with a trained research assistant) and three telephone calls over pregnancy, in which they will be provided with dietary and lifestyle advice and encouraged to make change using a SMART goals approach. Women randomised to the Standard Care Group will receive routine antenatal care. The primary outcome is infant birth weight >4 kg. Secondary outcomes will include adverse infant and maternal outcomes, maternal weight change, maternal diet and physical activity changes, maternal quality of life and emotional well-being, fetal growth and costs of healthcare. We will recruit 624 women to detect a reduction from 8.72% to 3.87% (alpha 0.05 (two-tailed); power 70%) in infants with birth weight >4 kg. Analyses will be intention to treat with estimates reported as relative risks and 95% CIs. Ethics and dissemination Ethical approval has been obtained from the Women's and Children's Hospital ethics committee. Findings will be disseminated widely via journal publication and conference presentation(s), and participants informed of results.
AB - Introduction Obesity represents a significant health burden, and WHO recognises the importance of preventing weight gain and subsequent development of obesity among adults who are within the healthy weight range. Women of reproductive age have demonstrated high rates of weight gain during pregnancy placing them at risk of becoming overweight or obese. We will evaluate the effects of dietary and physical activity advice on maternal, fetal and infant health outcomes, among pregnant women of normal body mass index (BMI). Methods and analysis We will conduct a randomised controlled trial, consenting and randomising women with a live singleton pregnancy between 10 +0 and 20 +0 weeks and BMI 18.5-24.9 kg/m 2 at first antenatal visit, from a tertiary maternity hospital. Women randomised to the Lifestyle Advice Group will receive three face-to-face sessions (two with a research dietitian and one with a trained research assistant) and three telephone calls over pregnancy, in which they will be provided with dietary and lifestyle advice and encouraged to make change using a SMART goals approach. Women randomised to the Standard Care Group will receive routine antenatal care. The primary outcome is infant birth weight >4 kg. Secondary outcomes will include adverse infant and maternal outcomes, maternal weight change, maternal diet and physical activity changes, maternal quality of life and emotional well-being, fetal growth and costs of healthcare. We will recruit 624 women to detect a reduction from 8.72% to 3.87% (alpha 0.05 (two-tailed); power 70%) in infants with birth weight >4 kg. Analyses will be intention to treat with estimates reported as relative risks and 95% CIs. Ethics and dissemination Ethical approval has been obtained from the Women's and Children's Hospital ethics committee. Findings will be disseminated widely via journal publication and conference presentation(s), and participants informed of results.
KW - dietary and lifestyle intervention
KW - gestational weight gain
KW - postpartum weight retention
UR - http://www.scopus.com/inward/record.url?scp=85051984399&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2017-019583
DO - 10.1136/bmjopen-2017-019583
M3 - Article
C2 - 29463591
AN - SCOPUS:85051984399
SN - 2044-6055
VL - 8
JO - BMJ open
JF - BMJ open
IS - 2
M1 - e019583
ER -