Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

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Abstract

Background

Gestational diabetes (GDM) impacts 8–18% of pregnancies and greatly increases both maternal and child risk of developing non-communicable diseases such as type 2 diabetes and obesity. Whilst lifestyle interventions in pregnancy and postpartum reduce this risk, a research translation gap remains around delivering implementable interventions with adequate population penetration and participation. Impact Diabetes Bump2Baby is an implementation project of an evidence-based system of care for the prevention of overweight and obesity. Bump2Baby and Me is the multicentre randomised controlled trial investigating the effectiveness of a mHealth coaching programme in pregnancy and postpartum for women at high risk of developing GDM.

Methods

Eight hundred women will be recruited in early pregnancy from 4 clinical sites within Ireland, the UK, Spain, and Australia. Women will be screened for eligibility using the validated Monash GDM screening tool. Participants will be enrolled from 12 to 24 weeks’ gestation and randomised on a 1:1 basis into the intervention or control arm. Alongside usual care, the intervention involves mHealth coaching via a smartphone application, which uses a combination of synchronous and asynchronous video and text messaging, and allows for personalised support and goal setting with a trained health coach. The control arm receives usual care. All women and their children will be followed from early pregnancy until 12 months postpartum. The primary outcome will be a difference in maternal body mass index (BMI) of 0.8 kg/m ² at 12 months postpartum. Secondary maternal and infant outcomes include the development of GDM, gestational weight gain, pregnancy outcomes, improvements in diet, physical activity, sleep, and neonatal weight and infant growth patterns. The 5-year project is funded by the EU Commission Horizon 2020 and the Australian National Health and Medical Research Council. Ethical approval has been received.

Discussion

Previous interventions have not moved beyond tightly controlled efficacy trials into routine service delivery. This project aims to provide evidence-based, sustainable support that could be incorporated into usual care for women during pregnancy and postpartum. This study will contribute evidence to inform the early prevention of non-communicable diseases like obesity and diabetes in mothers and the next generation.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12620001240932. Registered on 19 November 2020

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-021-05892-4.

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Most cited references 58

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The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research

Daniel J. Buysse, Charles Reynolds III, Timothy H Monk … (1989)

Despite the prevalence of sleep complaints among psychiatric patients, few questionnaires have been specifically designed to measure sleep quality in clinical populations. The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score. Clinical and clinimetric properties of the PSQI were assessed over an 18-month period with "good" sleepers (healthy subjects, n = 52) and "poor" sleepers (depressed patients, n = 54; sleep-disorder patients, n = 62). Acceptable measures of internal homogeneity, consistency (test-retest reliability), and validity were obtained. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p less than 0.001) in distinguishing good and poor sleepers. The clinimetric and clinical properties of the PSQI suggest its utility both in psychiatric clinical practice and research activities.

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International physical activity questionnaire: 12-country reliability and validity.

CORA L. CRAIG, ALISON L. MARSHALL, MICHAEL SJ??STR??M … (2003)

Physical inactivity is a global concern, but diverse physical activity measures in use prevent international comparisons. The International Physical Activity Questionnaire (IPAQ) was developed as an instrument for cross-national monitoring of physical activity and inactivity. Between 1997 and 1998, an International Consensus Group developed four long and four short forms of the IPAQ instruments (administered by telephone interview or self-administration, with two alternate reference periods, either the "last 7 d" or a "usual week" of recalled physical activity). During 2000, 14 centers from 12 countries collected reliability and/or validity data on at least two of the eight IPAQ instruments. Test-retest repeatability was assessed within the same week. Concurrent (inter-method) validity was assessed at the same administration, and criterion IPAQ validity was assessed against the CSA (now MTI) accelerometer. Spearman's correlation coefficients are reported, based on the total reported physical activity. Overall, the IPAQ questionnaires produced repeatable data (Spearman's rho clustered around 0.8), with comparable data from short and long forms. Criterion validity had a median rho of about 0.30, which was comparable to most other self-report validation studies. The "usual week" and "last 7 d" reference periods performed similarly, and the reliability of telephone administration was similar to the self-administered mode. The IPAQ instruments have acceptable measurement properties, at least as good as other established self-reports. Considering the diverse samples in this study, IPAQ has reasonable measurement properties for monitoring population levels of physical activity among 18- to 65-yr-old adults in diverse settings. The short IPAQ form "last 7 d recall" is recommended for national monitoring and the long form for research requiring more detailed assessment.

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The behaviour change wheel: A new method for characterising and designing behaviour change interventions

Susan Michie, Maartje M. van Stralen, Robert H. West (2012)

Background Improving the design and implementation of evidence-based practice depends on successful behaviour change interventions. This requires an appropriate method for characterising interventions and linking them to an analysis of the targeted behaviour. There exists a plethora of frameworks of behaviour change interventions, but it is not clear how well they serve this purpose. This paper evaluates these frameworks, and develops and evaluates a new framework aimed at overcoming their limitations. Methods A systematic search of electronic databases and consultation with behaviour change experts were used to identify frameworks of behaviour change interventions. These were evaluated according to three criteria: comprehensiveness, coherence, and a clear link to an overarching model of behaviour. A new framework was developed to meet these criteria. The reliability with which it could be applied was examined in two domains of behaviour change: tobacco control and obesity. Results Nineteen frameworks were identified covering nine intervention functions and seven policy categories that could enable those interventions. None of the frameworks reviewed covered the full range of intervention functions or policies, and only a minority met the criteria of coherence or linkage to a model of behaviour. At the centre of a proposed new framework is a 'behaviour system' involving three essential conditions: capability, opportunity, and motivation (what we term the 'COM-B system'). This forms the hub of a 'behaviour change wheel' (BCW) around which are positioned the nine intervention functions aimed at addressing deficits in one or more of these conditions; around this are placed seven categories of policy that could enable those interventions to occur. The BCW was used reliably to characterise interventions within the English Department of Health's 2010 tobacco control strategy and the National Institute of Health and Clinical Excellence's guidance on reducing obesity. Conclusions Interventions and policies to change behaviour can be usefully characterised by means of a BCW comprising: a 'behaviour system' at the hub, encircled by intervention functions and then by policy categories. Research is needed to establish how far the BCW can lead to more efficient design of effective interventions.

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Author and article information

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 28 December 2021

Publication date PMC-release: 28 December 2021

Publication date Collection: 2021

Volume: 22

Electronic Location Identifier: 963

Affiliations

[1 ]GRID grid.7886.1, ISNI 0000 0001 0768 2743, School of Agriculture and Food Science, , University College Dublin, ; Belfield, Dublin, Ireland

[2 ]GRID grid.415614.3, ISNI 0000 0004 0617 7309, UCD Perinatal Research Centre, School of Medicine, University College Dublin, , National Maternity Hospital, ; Dublin, Ireland

[3 ]GRID grid.5337.2, ISNI 0000 0004 1936 7603, Faculty of Health Sciences, , University of Bristol, ; Bristol, UK

[4 ]GRID grid.4489.1, ISNI 0000000121678994, Department of Paediatrics, School of Medicine, , University of Granada, ; Granada, Spain

[5 ]GRID grid.1002.3, ISNI 0000 0004 1936 7857, Monash Centre for Health Research and Implementation, School of Public Health and Preventive Medicine, , Monash University, Clayton, ; Melbourne, Victoria Australia

[6 ]LIVA Healthcare, Copenhagen, Denmark

[7 ]GRID grid.1021.2, ISNI 0000 0001 0526 7079, Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, , Deakin University Geelong, ; Geelong, Victoria Australia

[8 ]GRID grid.7048.b, ISNI 0000 0001 1956 2722, Department of Public Health, Section for Health Promotion and Health Services, , Aarhus University, ; Aarhus, Denmark

[9 ]GRID grid.5254.6, ISNI 0000 0001 0674 042X, Department of Public Health, Center for Health Economics and Policy, , University of Copenhagen, ; Copenhagen, Denmark

[10 ]GRID grid.7886.1, ISNI 0000 0001 0768 2743, School of Public Health, Physiotherapy, and Sports Science, , University College Dublin, ; Belfield, Dublin, Ireland

[11 ]GRID grid.1021.2, ISNI 0000 0001 0526 7079, Deakin Rural Health, School of Medicine, Faculty of Health, , Deakin University, ; Geelong, Victoria Australia

[12 ]GRID grid.5254.6, ISNI 0000 0001 0674 042X, Institut for Psykologi, Center for Sundhed of Samfund, , Københavns Universitet, ; Øster Farimagsgade, København K, Denmark

[13 ]GRID grid.1018.8, ISNI 0000 0001 2342 0938, University Department of Rural Health, , La Trobe University, ; Bendigo, Australia

Author information

Sharleen L. O’Reilly http://orcid.org/0000-0003-3547-6634

Article

Publisher ID: 5892

DOI: 10.1186/s13063-021-05892-4

PMC ID: 8713543

PubMed ID: 34963483

SO-VID: f437f126-d8a9-46df-8f35-bf95167bfb53

License:

Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.

History

Date received : 1 July 2021

Date accepted : 28 November 2021

Funding

Funded by: FundRef http://dx.doi.org/10.13039/100010676, h2020 societal challenges;

Award ID: 847984

Funded by: FundRef http://dx.doi.org/10.13039/501100000925, national health and medical research council;

Award ID: APP1194234

Award Recipient : Helena Teede

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: pregnancy,gestational diabetes,obesity,mhealth,implementation,postpartum,health coaching,maternal health,weight management,foetal programming

Data availability:

ScienceOpen disciplines: Medicine

Keywords: pregnancy, gestational diabetes, obesity, mhealth, implementation, postpartum, health coaching, maternal health, weight management, foetal programming

Bump2Baby and Me: protocol for a randomised trial of mHealth coaching for healthy gestational weight gain and improved postnatal outcomes in high-risk women and their children

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Abstract

Background

Methods

Discussion

Trial registration

Supplementary Information

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Point-of-Care Testing for Infectious Diseases Super Collection

Most cited references 58

The Pittsburgh sleep quality index: A new instrument for psychiatric practice and research

International physical activity questionnaire: 12-country reliability and validity.

The behaviour change wheel: A new method for characterising and designing behaviour change interventions

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