Testing the feasibility of a mobile technology intervention promoting healthy gestational weight gain in pregnant women (txt4two) - study protocol for a randomised controlled trial

BackgroundOverweight, obesity and excess gestational weight gain (GWG) are associated with negative health outcomes for mother and child in pregnancy and across the life course. Interventions promoting GWG within guidelines report mixed results. Most are time and cost intensive, which limits scalability. Mobile technologies (mHealth) offer low cost, ready access and individually-tailored support. We aim to test the feasibility of an mHealth intervention promoting healthy nutrition, physical activity and GWG in women who begin pregnancy overweight or obese.Methods/Designtxt4two is a parallel randomised control trial pilot recruiting women with a singleton, live gestation between 10+0 and 17+6 weeks at the first hospital antenatal clinic visit. Inclusion criteria are pre-pregnancy BMI > 25 kg/m2 and mobile phone ownership. One hundred consenting women will be randomised to intervention or control groups at a 1:1 ratio.All participants will receive standard antenatal care. In addition, the txt4two intervention will be delivered from baseline to 36 weeks gestation and consists of a tailored suite of theoretically-grounded, evidence-based intervention strategies focusing on healthy nutrition, physical activity and GWG. This includes: mobile phone interactive text messages promoting positive health behaviours, goal setting and self-monitoring; video messages; an information website; and a private moderated Facebook® chat forum.The primary outcome is the feasibility of the intervention. Secondary outcomes include GWG and participants’ knowledge and behaviour regarding diet and physical activity during pregnancy.DiscussionFindings will inform the development of larger-scale mHealth programmes to improve the delivery of healthy pregnancy nutrition, physical activity and GWG, that could be widely translated and disseminated.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRNU111111544397. Date of registration: 19 March 2014.

[1]  G. Eysenbach.  CONSORT-EHEALTH: Improving and Standardizing Evaluation Reports of Web-based and Mobile Health Interventions , 2011, Journal of medical Internet research.

[2]  B W Mol,et al.  Effects of interventions in pregnancy on maternal weight and obstetric outcomes: meta-analysis of randomised evidence , 2012, BMJ : British Medical Journal.

[3]  E. Gibney,et al.  Technology-supported dietary and lifestyle interventions in healthy pregnant women: a systematic review , 2014, European Journal of Clinical Nutrition.

[4]  J. Dodd,et al.  Developing a tool for obtaining maternal skinfold thickness measurements and assessing inter-observer variability among pregnant women who are overweight and obese , 2013, BMC Pregnancy and Childbirth.

[5]  Maria E Fernandez,et al.  How we design feasibility studies. , 2009, American journal of preventive medicine.

[6]  Alireza Ahmadvand.  CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions , 2011 .

[7]  Briege M Lagan,et al.  Internet use in pregnancy informs women's decision making: a web-based survey. , 2010, Birth.

[8]  J. Shults,et al.  Gestational weight gain and risk of overweight in the offspring at age 7 y in a multicenter, multiethnic cohort study. , 2008, The American journal of clinical nutrition.

[9]  K. Stange,et al.  Racial, ethnic, and socioeconomic differences in the incidence of obesity related to childbirth. , 2009, American journal of public health.

[10]  B. Fjeldsoe,et al.  Behavior change interventions delivered by mobile telephone short-message service. , 2009, American journal of preventive medicine.

[11]  E. Finkelstein,et al.  Obesity and severe obesity forecasts through 2030. , 2012, American journal of preventive medicine.

[12]  Gunther Eysenbach,et al.  CONSORT-EHEALTH: Implementation of a Checklist for Authors and Editors to Improve Reporting of Web-Based and Mobile Randomized Controlled Trials , 2013, MedInfo.

[13]  S. Murphy,et al.  The multiphase optimization strategy (MOST) and the sequential multiple assignment randomized trial (SMART): new methods for more potent eHealth interventions. , 2007, American journal of preventive medicine.

[14]  Ann L. Yaktine,et al.  Weight Gain During Pregnancy , 2009 .

[15]  Ralph Maddison,et al.  A Development and Evaluation Process for mHealth Interventions: Examples From New Zealand , 2012, Journal of health communication.

[16]  J. Brug,et al.  Resilience to obesity among socioeconomically disadvantaged women: the READI study , 2012, International Journal of Obesity.

[17]  Ann L. Yaktine,et al.  Weight Gain During Pregnancy , 2009 .

[18]  Helen Croker,et al.  Lifestyle interventions for overweight and obese pregnant women to improve pregnancy outcome: systematic review and meta-analysis , 2012, BMC Medicine.

[19]  P. Sampson,et al.  Fine Particulate Air Pollution and the Progression of Carotid Intima-Medial Thickness: A Prospective Cohort Study from the Multi-Ethnic Study of Atherosclerosis and Air Pollution , 2013, PLoS medicine.

[20]  J. Kuk,et al.  Characteristics of Weight Gain in Pregnancy Among Canadian Women , 2012, Maternal and Child Health Journal.

[21]  C. Weisman,et al.  Preconception predictors of weight gain during pregnancy: prospective findings from the Central Pennsylvania Women's Health Study. , 2010, Women's health issues : official publication of the Jacobs Institute of Women's Health.

[22]  Ruth P Saunders,et al.  Developing a Process-Evaluation Plan for Assessing Health Promotion Program Implementation: A How-To Guide , 2005, Health promotion practice.

[23]  M. Teare,et al.  Sample size requirements to estimate key design parameters from external pilot randomised controlled trials: a simulation study , 2014, Trials.

[24]  Youth,et al.  Weight Gain During Pregnancy: Reexamining the Guidelines , 2010 .

[25]  Abdullah Al Mamun,et al.  Associations of excess weight gain during pregnancy with long-term maternal overweight and obesity: evidence from 21 y postpartum follow-up. , 2010, The American journal of clinical nutrition.

[26]  Abdullah Al Mamun,et al.  Associations of maternal pre-pregnancy obesity and excess pregnancy weight gains with adverse pregnancy outcomes and length of hospital stay , 2011, BMC pregnancy and childbirth.

[27]  L. Massey,et al.  Development of an assessment form: attitude toward weight gain during pregnancy. , 1985, Journal of the American Dietetic Association.

[28]  A. Haines,et al.  The Effectiveness of Mobile-Health Technology-Based Health Behaviour Change or Disease Management Interventions for Health Care Consumers: A Systematic Review , 2013, PLoS medicine.

[29]  Meera Viswanathan,et al.  Outcomes of maternal weight gain. , 2008, Evidence report/technology assessment.

[30]  M. Permezel,et al.  Reducing excessive weight gain in pregnancy: a randomised controlled trial , 2009, The Medical journal of Australia.

[31]  Frederick Muench,et al.  Understanding Messaging Preferences to Inform Development of Mobile Goal-Directed Behavioral Interventions , 2014, Journal of medical Internet research.

[32]  J. Dodd,et al.  Antenatal interventions for overweight or obese pregnant women: a systematic review of randomised trials , 2010, BJOG : an international journal of obstetrics and gynaecology.

[33]  B. Heitmann,et al.  Systematic review of clinical trials on dietary interventions to prevent excessive weight gain during pregnancy among normal weight, overweight and obese women , 2011, BMC pregnancy and childbirth.

[34]  H. Beck-Nielsen,et al.  Gestational weight gain and pregnancy outcomes in 481 obese glucose-tolerant women. , 2005, Diabetes care.

[35]  Eric R. Ziegel,et al.  Generalized Linear Models , 2002, Technometrics.

[36]  A. Siega-Riz,et al.  The relationship between pregnancy weight gain and glucose tolerance status among black and white women in central North Carolina. , 2006, American journal of obstetrics and gynecology.

[37]  H. Skouteris,et al.  Interventions designed to limit gestational weight gain: a systematic review of theory and meta‐analysis of intervention components , 2013, Obesity reviews : an official journal of the International Association for the Study of Obesity.

[38]  S. Phelan,et al.  Reducing Excessive Gestational Weight Gain: Lessons from the Weight Control Literature and Avenues for Future Research , 2011, Women's health.

[39]  Lisa Chasan-Taber,et al.  Development and validation of a Pregnancy Physical Activity Questionnaire. , 2004, Medicine and science in sports and exercise.

[40]  C. Sims,et al.  Randomized controlled trial to prevent excessive weight gain in pregnant women , 2002, International Journal of Obesity.

[41]  A. Beyerlein,et al.  Physical activity and gestational weight gain: a meta‐analysis of intervention trials , 2011, BJOG : an international journal of obstetrics and gynaecology.

[42]  D. Rennie,et al.  SPIRIT 2013 statement: defining standard protocol items for clinical trials. , 2013, Annals of internal medicine.

[43]  J. Yang.  Of markets and rights: Discourse in the 2008 and 2013 Global Action Plan for the Prevention and Control of Noncommunicable Diseases , 2016 .

[44]  R. Shaban,et al.  ‘The Australian Immunisation Handbook 8th Edition’. National Health and Medical Research Council, Australian Government. Canberra: Commonwealth of Australia; 2003. 350 pages, ISBN 0-642-82204-2 , 2015 .

[45]  Andreas Beyerlein,et al.  Can gestational weight gain be modified by increasing physical activity and diet counseling? A meta-analysis of interventional trials. , 2010, The American journal of clinical nutrition.

[46]  S. Wilkinson,et al.  Nutrition and maternal health: What women want and can we provide it? , 2010 .

[47]  Shelly M Asbee,et al.  Preventing Excessive Weight Gain During Pregnancy Through Dietary and Lifestyle Counseling: A Randomized Controlled Trial , 2009, Obstetrics and gynecology.

[48]  C. Olson,et al.  Evaluation of psychosocial measures for understanding weight-related behaviors in pregnant women , 2001, Annals of behavioral medicine : a publication of the Society of Behavioral Medicine.

[49]  S. Michie,et al.  A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: The CALO-RE taxonomy , 2011, Psychology & health.

[50]  Y. Miller,et al.  The Effects of a Woman-Focused, Woman-Held Resource on Preventive Health Behaviors During Pregnancy: The Pregnancy Pocketbook , 2010, Women & health.

[51]  P. Lumbiganon,et al.  Interventions for preventing excessive weight gain during pregnancy. , 2012, The Cochrane database of systematic reviews.

[52]  Farris K Timimi.  Medicine, morality and health care social media , 2012, BMC Medicine.