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

Jane Catherine Willcox,Karen Jane Campbell,Deborah Pidd,Shelley Ann Wilkinson,David Andrew Crawford,Ralph Maddison,Anne Griffiths,Nelly Moshonas,Kylie Ball,Robyn Whittaker,Alexis Shub,Martha Lappas,Elizabeth Anne Mccarthy,Elise Fraser,Brianna Fjeldsoe

doi:10.1186/s13063-015-0730-1

Abstract

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.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-015-0730-1) contains supplementary material, which is available to authorized users.

Highlights

Overweight, obesity and excess gestational weight gain (GWG) are associated with negative health outcomes for mother and child in pregnancy and across the life course
Findings 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
Results will be Discussion This paper presents an randomised controlled trial (RCT) protocol to determine the feasibility of an mHealth intervention to promote healthy nutrition, physical activity and weight gain in pregnant women who were overweight or obese prior to pregnancy

Summary

Discussion

This paper presents an RCT protocol to determine the feasibility of an mHealth intervention to promote healthy nutrition, physical activity and weight gain in pregnant women who were overweight or obese prior to pregnancy. Previous authors have called for high-quality RCTs promoting healthy GWG grounded in health behaviour theoretical frameworks with adequate sample sizes and feasibility for translation to public health settings [15,23] If effective, this mHealth intervention offers a programme that could be delivered for large numbers of pregnant women. Given that future intervention success depends on the acceptability of the delivery modality to the target group, and their providers of care, the intervention model and elements of the model require consumer testing to ensure resonance and relevance This feasibility study has been designed to provide unique data regarding the suitability of an mHealthdelivered intervention to promote healthy diet, activity and weight in pregnant women.

Background

Findings