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

doi:10.1186/s13063-015-0730-1

Randomized Controlled Trial

. 2015 May 7:16:209.

doi: 10.1186/s13063-015-0730-1.

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 Willcox¹, Karen Jane Campbell², Elizabeth Anne McCarthy^{3

4}, Shelley Ann Wilkinson⁵, Martha Lappas^{6

7}, Kylie Ball⁸, Brianna Fjeldsoe⁹, Anne Griffiths¹⁰, Robyn Whittaker¹¹, Ralph Maddison¹², Alexis Shub^{13

14}, Deborah Pidd¹⁵, Elise Fraser¹⁶, Nelly Moshonas¹⁷, David Andrew Crawford¹⁸

Affiliations

¹ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. jwillcox@deakin.edu.au.
² Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. karen.campbell@deakin.edu.au.
³ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. eamcca@unimelb.edu.au.
⁴ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. eamcca@unimelb.edu.au.
⁵ Mater Mothers Hospital/Mater Research, Queensland, Australia. shelley.wilkinson@mater.org.au.
⁶ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. mlappas@unimelb.edu.au.
⁷ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. mlappas@unimelb.edu.au.
⁸ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. kylie.ball@deakin.edu.au.
⁹ Cancer Prevention Research Centre, School of Population Health, University of Queensland, Queensland, Australia. b.fjeldsoe@sph.uq.edu.au.
¹⁰ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. anne.griffiths@deakin.edu.au.
¹¹ National Institute for Health Innovation, University of Auckland, Auckland, New Zealand. r.whittaker@nihi.auckland.ac.nz.
¹² National Institute for Health Innovation, University of Auckland, Auckland, New Zealand. r.maddison@nihi.auckland.ac.nz.
¹³ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. ashub@internode.on.net.
¹⁴ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. ashub@internode.on.net.
¹⁵ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. DPidd@mercy.com.au.
¹⁶ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. EFraser@mercy.com.au.
¹⁷ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. NMoshonas@mercy.com.au.
¹⁸ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. david.crawford@deakin.edu.au.

PMID: 25947578
PMCID: PMC4426547
DOI: 10.1186/s13063-015-0730-1

Randomized Controlled Trial

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 et al. Trials. 2015.

. 2015 May 7:16:209.

doi: 10.1186/s13063-015-0730-1.

Authors

Affiliations

¹ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. jwillcox@deakin.edu.au.
² Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. karen.campbell@deakin.edu.au.
³ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. eamcca@unimelb.edu.au.
⁴ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. eamcca@unimelb.edu.au.
⁵ Mater Mothers Hospital/Mater Research, Queensland, Australia. shelley.wilkinson@mater.org.au.
⁶ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. mlappas@unimelb.edu.au.
⁷ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. mlappas@unimelb.edu.au.
⁸ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. kylie.ball@deakin.edu.au.
⁹ Cancer Prevention Research Centre, School of Population Health, University of Queensland, Queensland, Australia. b.fjeldsoe@sph.uq.edu.au.
¹⁰ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. anne.griffiths@deakin.edu.au.
¹¹ National Institute for Health Innovation, University of Auckland, Auckland, New Zealand. r.whittaker@nihi.auckland.ac.nz.
¹² National Institute for Health Innovation, University of Auckland, Auckland, New Zealand. r.maddison@nihi.auckland.ac.nz.
¹³ Department of Obstetrics and Gynaecology, University of Melbourne, Melbourne, Victoria, Australia. ashub@internode.on.net.
¹⁴ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. ashub@internode.on.net.
¹⁵ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. DPidd@mercy.com.au.
¹⁶ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. EFraser@mercy.com.au.
¹⁷ Mercy Hospital for Women, University of Melbourne, Melbourne, Victoria, Australia. NMoshonas@mercy.com.au.
¹⁸ Centre for Physical Activity and Nutrition Research, Deakin University, Geelong, Victoria, Australia. david.crawford@deakin.edu.au.

PMID: 25947578
PMCID: PMC4426547
DOI: 10.1186/s13063-015-0730-1

Abstract

Background: 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. 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/design: txt4two 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/m(2) 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.

Discussion: 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.

Trial registration: Australian New Zealand Clinical Trials Registry: ACTRNU111111544397 . Date of registration: 19 March 2014.

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References

1. World Health Organization . Global action plan for the prevention and control of noncommunicable diseases 2013–2020. Geneva: World Health Organization; 2013.
1. Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, et al. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012;42(6):563–70. doi: 10.1016/j.amepre.2011.10.026. - DOI - PubMed
1. Davis EM, Zyzanski SJ, Olson CM, Stange KC, Horwitz RI. Racial, ethnic, and socioeconomic differences in the incidence of obesity related to childbirth. Am J Public Health. 2009;99(2):294–9. doi: 10.2105/AJPH.2007.132373. - DOI - PMC - PubMed
1. IOM NRC, Rasmussen K, Yaktine A. Weight gain during pregnancy: reexamining the guidelines. Washington: The National Academies Press; 2009. - PubMed
1. Viswanathan M, Siega-Riz A, Moos M-K, Deierlein A, Mumford S, Knaack J, et al. Outcomes of maternal weight gain. Evidence report/technology assessment No. 168. Rockville, MD: Prepared by RTI International-University of North Carolina Evidence-based Practice Center under Contract No. 290-02-0016; 2008. - PMC - PubMed

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[1] World Health Organization . Global action plan for the prevention and control of noncommunicable diseases 2013–2020. Geneva: World Health Organization; 2013.

[2] World Health Organization . Global action plan for the prevention and control of noncommunicable diseases 2013–2020. Geneva: World Health Organization; 2013.

[3] Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, et al. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012;42(6):563–70. doi: 10.1016/j.amepre.2011.10.026. - DOI - PubMed

[4] Finkelstein EA, Khavjou OA, Thompson H, Trogdon JG, Pan L, Sherry B, et al. Obesity and severe obesity forecasts through 2030. Am J Prev Med. 2012;42(6):563–70. doi: 10.1016/j.amepre.2011.10.026. - DOI - PubMed

[5] Davis EM, Zyzanski SJ, Olson CM, Stange KC, Horwitz RI. Racial, ethnic, and socioeconomic differences in the incidence of obesity related to childbirth. Am J Public Health. 2009;99(2):294–9. doi: 10.2105/AJPH.2007.132373. - DOI - PMC - PubMed

[6] Davis EM, Zyzanski SJ, Olson CM, Stange KC, Horwitz RI. Racial, ethnic, and socioeconomic differences in the incidence of obesity related to childbirth. Am J Public Health. 2009;99(2):294–9. doi: 10.2105/AJPH.2007.132373. - DOI - PMC - PubMed

[7] IOM NRC, Rasmussen K, Yaktine A. Weight gain during pregnancy: reexamining the guidelines. Washington: The National Academies Press; 2009. - PubMed

[8] IOM NRC, Rasmussen K, Yaktine A. Weight gain during pregnancy: reexamining the guidelines. Washington: The National Academies Press; 2009. - PubMed

[9] Viswanathan M, Siega-Riz A, Moos M-K, Deierlein A, Mumford S, Knaack J, et al. Outcomes of maternal weight gain. Evidence report/technology assessment No. 168. Rockville, MD: Prepared by RTI International-University of North Carolina Evidence-based Practice Center under Contract No. 290-02-0016; 2008. - PMC - PubMed

[10] Viswanathan M, Siega-Riz A, Moos M-K, Deierlein A, Mumford S, Knaack J, et al. Outcomes of maternal weight gain. Evidence report/technology assessment No. 168. Rockville, MD: Prepared by RTI International-University of North Carolina Evidence-based Practice Center under Contract No. 290-02-0016; 2008. - PMC - PubMed

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

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

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