title: Pregnancy, exercise and nutrition research study with smart phone app support (Pears): Study protocol of a randomized controlled trial.
abstract: OBJECTIVE
  Maternal adiposity confers an increased risk of GDM in pregnancy. A low glycemic index (GI) dietary intervention has been found to improve glucose homeostasis and reduce gestational weight gain. Mobile Health (mHealth) Technology-assisted interventions are becoming commonplace as an aid to treating many chronic diseases. The aim of this study is to assess the impact of a 'healthy lifestyle package' with mHealth smart phone technology as support compared with usual care on the incidence of GDM in an overweight and obese pregnant population.
  
  
  METHODS
  We propose a randomized controlled trial of an mHealth assisted healthy lifestyle intervention package versus standard obstetric care in pregnant women with a BMI ≥25kg/m(2)-39.9kg/m(2). Patients are randomized to control or intervention group in a 1:1 ratio. The intervention arm healthy lifestyle package includes a motivational counseling session to encourage behavior change, involving targeted, low GI nutritional advice and daily physical activity prescription delivered before 18weeks gestation, as well as a smart phone app to provide ongoing healthy lifestyle advice and support throughout pregnancy. The primary outcome is the incidence of GDM at 29weeks' gestation and power analysis indicates that 253 women are required in each group to detect a difference.
  
  
  CONCLUSIONS
  This will be the first clinical trial to evaluate the effectiveness of a smart phone technology-assisted targeted healthy lifestyle intervention, which is grounded in behavior change theories and techniques, to support antenatal management of an overweight and obese pregnant population in preventing GDM.
authors.affiliation: UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland. Electronic address: maria.kennelly@ucd.ie.
authors.forename: Maria A
authors.initials: MA
authors.lastname: Kennelly
authors.affiliation: UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland.
authors.forename: Kate
authors.initials: K
authors.lastname: Ainscough
authors.affiliation: UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland.
authors.forename: Karen
authors.initials: K
authors.lastname: Lindsay
authors.affiliation: UCD Institute of Food and Health, Ireland.
authors.forename: Eileen
authors.initials: E
authors.lastname: Gibney
authors.affiliation: Food Business & Development, UCC, Ireland.
authors.forename: Mary
authors.initials: M
authors.lastname: Mc Carthy
authors.affiliation: UCD Obstetrics & Gynecology, School of Medicine and Medical Science, University College Dublin, National Maternity Hospital, Dublin, Ireland.
authors.forename: Fionnuala M
authors.initials: FM
authors.lastname: McAuliffe
mesh_terms: D000328:Adult; D016640:Diabetes, Gestational / Q000517:prevention & control*; D004035:Diet Therapy / Q000379:methods*; D005081:Exercise Therapy / Q000379:methods*; D005260:Female; D038321:Glycemic Index; D006801:Humans; D063731:Mobile Applications; D062405:Motivational Interviewing; D009043:Motor Activity; D009765:Obesity / Q000628:therapy*; D050177:Overweight / Q000628:therapy; D011247:Pregnancy; D011248:Pregnancy Complications / Q000628:therapy*; D011295:Prenatal Care; D000068997:Smartphone; D017216:Telemedicine; D055815:Young Adult
keywords: Exercise; Low glycemic index; Obesity; Overweight; Pregnancy; Smart phone technology