Effect of a behavioural intervention in obese pregnant women (the UPBEAT study): a multicentre, randomised controlled trial
Lucilla Poston, Ruth Bell, Helen Croker, Angela C Flynn, Keith M Godfrey, Louise Goff, Louise Hayes, Nina Khazaezadeh, Scott M Nelson, Eugene Oteng-Ntim, Dharmintra Pasupathy, Nashita Patel, Stephen C Robson, Jane Sandall, Thomas A B Sanders, Naveed Sattar, Paul T Seed, Jane Wardle, Melissa K Whitworth, Annette L Briley, UPBEAT Trial Consortium, Lucilla Poston, Andrew Shennan, Annette Briley, Claire Singh, Paul Seed, Jane Sandall, Thomas Sanders, Nashita Patel, Angela Flynn, Shirlene Badger, Suzanne Barr, Bridget Holmes, Louise Goff, Clare Hunt, Judy Filmer, Jeni Fetherstone, Laura Scholtz, Hayley Tarft, Anna Lucas, Tsigerada Tekletdadik, Deborah Ricketts, Carolyn Gill, Alex Seroge Ignatian, Catherine Boylen, Funso Adegoke, Elodie Lawley, James Butler, Rahat Maitland, Matias Vieira, Dharmintra Pasupathy, Louise Goff, Eugene Oteng-Ntim, Nina Khazaezadeh, Jill Demilew, Sile O'Connor, Yvonne Evans, Susan O'Donnell, Ari de la Llera, Georgina Gutzwiller, Linda Hagg, Stephen Robson, Ruth Bell, Louise Hayes, Tarja Kinnunen, Catherine McParlin, Nicola Miller, Alison Kimber, Jill Riches, Carly Allen, Claire Boag, Fiona Campbell, Andrea Fenn, Sarah Ritson, Alison Rennie, Robin Durkin, Gayle Gills, Roger Carr, Scott Nelson, Naveed Sattar, Therese McSorley, Hilary Alba, Kirsteen Paterson, Janet Johnston, Suzanne Clements, Maxine Fernon, Savannah Bett, Laura Rooney, Sinead Miller, Paul Welsh, Lynn Cherry, Melissa Whitworth, Natalie Patterson, Sarah Lee, Rachel Grimshaw, Christine Hughes, Jay Brown, Kim Hinshaw, Gillian Campbell, Joanne Knight, Diane Farrar, Vicky Jones, Gillian Butterfield, Jennifer Syson, Jennifer Eadle, Dawn Wood, Merane Todd, Asma Khalil, Deborah Brown, Paola Fernandez, Emma Cousins, Melody Smith, Jane Wardle, Helen Croker, Laura Broomfield, Keith Godfrey, Sian Robinson, Sarah Canadine, Lynne Greenwood, Catherine Nelson-Piercy, Stephanie Amiel, Gail Goldberg, Daghni Rajasingham, Penny Jackson, Sara Kenyon, Patrick Catalano, Lucilla Poston, Ruth Bell, Helen Croker, Angela C Flynn, Keith M Godfrey, Louise Goff, Louise Hayes, Nina Khazaezadeh, Scott M Nelson, Eugene Oteng-Ntim, Dharmintra Pasupathy, Nashita Patel, Stephen C Robson, Jane Sandall, Thomas A B Sanders, Naveed Sattar, Paul T Seed, Jane Wardle, Melissa K Whitworth, Annette L Briley, UPBEAT Trial Consortium, Lucilla Poston, Andrew Shennan, Annette Briley, Claire Singh, Paul Seed, Jane Sandall, Thomas Sanders, Nashita Patel, Angela Flynn, Shirlene Badger, Suzanne Barr, Bridget Holmes, Louise Goff, Clare Hunt, Judy Filmer, Jeni Fetherstone, Laura Scholtz, Hayley Tarft, Anna Lucas, Tsigerada Tekletdadik, Deborah Ricketts, Carolyn Gill, Alex Seroge Ignatian, Catherine Boylen, Funso Adegoke, Elodie Lawley, James Butler, Rahat Maitland, Matias Vieira, Dharmintra Pasupathy, Louise Goff, Eugene Oteng-Ntim, Nina Khazaezadeh, Jill Demilew, Sile O'Connor, Yvonne Evans, Susan O'Donnell, Ari de la Llera, Georgina Gutzwiller, Linda Hagg, Stephen Robson, Ruth Bell, Louise Hayes, Tarja Kinnunen, Catherine McParlin, Nicola Miller, Alison Kimber, Jill Riches, Carly Allen, Claire Boag, Fiona Campbell, Andrea Fenn, Sarah Ritson, Alison Rennie, Robin Durkin, Gayle Gills, Roger Carr, Scott Nelson, Naveed Sattar, Therese McSorley, Hilary Alba, Kirsteen Paterson, Janet Johnston, Suzanne Clements, Maxine Fernon, Savannah Bett, Laura Rooney, Sinead Miller, Paul Welsh, Lynn Cherry, Melissa Whitworth, Natalie Patterson, Sarah Lee, Rachel Grimshaw, Christine Hughes, Jay Brown, Kim Hinshaw, Gillian Campbell, Joanne Knight, Diane Farrar, Vicky Jones, Gillian Butterfield, Jennifer Syson, Jennifer Eadle, Dawn Wood, Merane Todd, Asma Khalil, Deborah Brown, Paola Fernandez, Emma Cousins, Melody Smith, Jane Wardle, Helen Croker, Laura Broomfield, Keith Godfrey, Sian Robinson, Sarah Canadine, Lynne Greenwood, Catherine Nelson-Piercy, Stephanie Amiel, Gail Goldberg, Daghni Rajasingham, Penny Jackson, Sara Kenyon, Patrick Catalano
Abstract
Background: Behavioural interventions might improve clinical outcomes in pregnant women who are obese. We aimed to investigate whether a complex intervention addressing diet and physical activity could reduce the incidence of gestational diabetes and large-for-gestational-age infants.
Methods: The UK Pregnancies Better Eating and Activity Trial (UPBEAT) is a randomised controlled trial done at antenatal clinics in eight hospitals in multi-ethnic, inner-city locations in the UK. We recruited pregnant women (15-18 weeks plus 6 days of gestation) older than 16 years who were obese (BMI ≥30 kg/m(2)). We randomly assigned participants to either a behavioural intervention or standard antenatal care with an internet-based, computer-generated, randomisation procedure, minimising by age, ethnic origin, centre, BMI, and parity. The intervention was delivered once a week through eight health trainer-led sessions. Primary outcomes were gestational diabetes (diagnosed with an oral glucose tolerance test and by criteria from the International Association of Diabetes in Pregnancy Study Groups) and large-for-gestational-age infants (≥90th customised birthweight centile). Analysis was by intention to treat. This trial is registered with Current Controlled Trials, ISCRTN89971375. Recruitment and pregnancy outcomes are complete but childhood follow-up is ongoing.
Findings: Between March 31, 2009, and June 2, 2014, we assessed 8820 women for eligibility and recruited 1555, with a mean BMI of 36·3 kg/m(2) (SD 4·8). 772 were randomly assigned to standard antenatal care and 783 were allocated the behavioural intervention, of which 651 and 629 women, respectively, completed an oral glucose tolerance test. Gestational diabetes was reported in 172 (26%) women in the standard care group compared with 160 (25%) in the intervention group (risk ratio 0·96, 95% CI 0·79-1·16; p=0·68). 61 (8%) of 751 babies in the standard care group were large for gestational age compared with 71 (9%) of 761 in the intervention group (1·15, 0·83-1·59; p=0·40). Thus, the primary outcomes did not differ between groups, despite improvements in some maternal secondary outcomes in the intervention group, including reduced dietary glycaemic load, gestational weight gain, and maternal sum-of-skinfold thicknesses, and increased physical activity. Adverse events included neonatal death (two in the standard care group and three in the intervention group) and fetal death in utero (ten in the standard care group and six in the intervention group). No maternal deaths were reported. Incidence of miscarriage (2% in the standard care group vs 2% in the intervention group), major obstetric haemorrhage (1% vs 3%), and small-for-gestational-age infants (≤5th customised birthweight centile; 6% vs 5%) did not differ between groups.
Interpretation: A behavioural intervention addressing diet and physical activity in women with obesity during pregnancy is not adequate to prevent gestational diabetes, or to reduce the incidence of large-for-gestational-age infants.
Funding: National Institute for Health Research, Guys and St Thomas' Charity, Chief Scientist Office Scotland, Tommy's Charity.
Copyright © 2015 Poston et al. Open Access article distributed under the terms of CC BY-NC-ND. Published by Elsevier Ltd.. All rights reserved.
Source: PubMed