FitMum session

FitMum - A process evaluation of the FitMum intervention

Motivation and maintenance of physical activity during pregnancy. 

Background

Complex interventions are usually described as interventions containing multiple interacting components and are frequently developed to address health system deficiencies experienced by patients and providers (1,2). Several initiatives have focused on the assessment of validity and presentation of study results (3,4), but only half of the studies published on non-pharmacological interventions in well accepted journals leave information about which components that are included in the interventions (5). It leaves clinicians, patients, and other decision makers left unclear about how to reliably implement the intervention. Evaluation of complex interventions is needed to replicate or build on research findings (6).

To increase the likelihood of successful implementation of interventions and promote dissemination evaluating outcomes other than effectiveness is of great importance. To do this, the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework is used to systematically assess key dimensions and robustness of an intervention and the potential for up-scaling and develop in additional settings (7–9). The context will be studied primarily from individual- and intervention-level perspectives by use of both quantitative and qualitative data. The focus will be on the mechanisms that lead the interventions to work or not work and to open the "black box" between providing and receiving or developing and implementing (10–12). Data will be collected alongside the implementation of the two exercise programs.

The research project FitMum will generate evidence about how to implement physical activity in pregnant women’s everyday life by testing the efficacy of two very different exercise programs on physical activity levels during pregnancy. Fewer than four out of ten Danish pregnant women achieve the national recommended level of physical activity (13,14) even though it is well known that physical activity during pregnancy plays an important role for future mothers - and probably also for the next generation - in relation to obesity and related lifestyle disorders, which escalates globally (15,16). The two interventions, structured supervised exercise training and motivational counseling supported by health technology, are designed and developed based on principles for complex interventions to meet the motivators and overcome the specific barriers for physical activity among pregnant women (1,17). 

Project objectives

This PhD project is nested in the FitMum Study and will generate evidence about how to implement physical activity in pregnant women’s everyday life by testing the efficacy of two very different exercise programs on physical activity levels during pregnancy. Besides investigating the efficacy of the FitMum interventions, this project will explore if the FitMum interventions was delivered as intended, whether, how and why the interventions had an impact through participant’s and provider’s perspective and implementation barriers and facilitators of a complex intervention.

FitMum is carried out in collaboration between University of Copenhagen, Nordsjælland’s Hospital, Technical University of Denmark, Aarhus University and international researchers and brings together an interdisciplinary team of experts. The research project will fill the gap in evidence and practice on how to implement physical activity in pregnant women’s everyday life and provide the public sector with evidence of the effect of physical activity programs that can be made available to all pregnant women, independent of the social determinants of health.

References

  1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. BMJ. 2008;337(a1655):1–6.
  2. Liu H, Lindley R, Alim M, Felix C, Gandhi DBC, Verma SJ, et al. Protocol for process evaluation of a randomised controlled trial of family-led rehabilitation post stroke (ATTEND) in India. BMJ Open [Internet]. 2016 Sep 15 [cited 2018 Feb 19];6(9):e012027. Available from: http://www.ncbi.nlm.nih.gov/pubmed/27633636
  3.  Glasziou P, Meats E, Heneghan C, Shepperd S. What is missing from descriptions of treatment in trials and reviews? BMJ [Internet]. 2008 Jun 28 [cited 2018 Sep 20];336(7659):1472–4. Available from: http://www.ncbi.nlm.nih.gov/pubmed/18583680
  4.  Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P. Extending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration. Ann Intern Med [Internet]. 2008 Feb 19 [cited 2018 Sep 20];148(4):295. Available from: http://annals.org/article.aspx?doi=10.7326/0003-4819-148-4-200802190-00008
  5.  Hoffmann TC, Erueti C, Glasziou PP. Poor description of non-pharmacological interventions: Analysis of consecutive sample of randomised trials. BMJ. 2013;347(7924):1–10.
  6. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. BMJ. 2014;348(March):1–13.
  7. King DK, Glasgow RE, Leeman-Castillo B. Reaiming RE-AIM: using the model to plan, implement, and evaluate the effects of environmental change approaches to enhancing population health. Am J Public Health [Internet]. 2010 Nov [cited 2018 Mar 8];100(11):2076–84. Available from: http://www.ncbi.nlm.nih.gov/pubmed/20864705
  8. Glasgow RE, Vogt TM, Boles SM. Evaluating the Public Health Impact of Health Promotion Interventions: The RE-AIM Framework. 1999 [cited 2018 Mar 8];89(9). Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1508772/pdf/amjph00009-0018.pdf
  9. Forman J, Heisler M, Damschroder LJ, Kaselitz E, Kerr EA. Development and application of the RE-AIM QuEST mixed methods framework for program evaluation. Prev Med reports [Internet]. 2017 Jun [cited 2018 Mar 13];6:322–8. Available from: http://www.ncbi.nlm.nih.gov/pubmed/28451518
  10. Dybboe Bjerre E, Blaedel A, Hansen G. Komplekse interventioner i medicinsk forskning. [cited 2018 Feb 22]; Available from: http://ugeskriftet.dk/files/scientific_article_files/2018-02/V06170479_0.pdf
  11. Oakley A, Strange V, Bonell C, Allen E, Stephenson J, RIPPLE Study Team. Process evaluation in randomised controlled trials of complex interventions. BMJ [Internet]. 2006 Feb 18 [cited 2018 Feb 19];332(7538):413–6. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16484270
  12. F. Moore G, Raisanen L, Moore L, Ud Din N, Murphy S. Mixed-method process evaluation of the Welsh National Exercise Referral Scheme. Health Educ [Internet]. 2013 Oct 14 [cited 2018 Feb 20];113(6):476–501. Available from: http://www.emeraldinsight.com/doi/10.1108/HE-08-2012-0046
  13. Broberg L, Ersbøll AS, Backhausen MG, Damm P, Tabor A, Hegaard HK. Compliance with national recommendations for exercise during early pregnancy in a Danish cohort. BMC Pregnancy Childbirth. 2015;15:317.
  14. The Danish Health Authorities. Recommendations for pregnant women [Internet]. 2014. Available from: https://www.sst.dk/en/health-and-lifestyle/physical-activity/recommendations/pregnant-women
  15. World Health Organisation (WHO). Good Maternal Nutrition. The best start in life. 2016;
  16. Adamo KB, Ferraro ZM, Brett KE. Can we modify the intrauterine environment to halt the intergenerational cycle of obesity? Int J Environ Res Public Health. 2012;9(4):1263–307.
  17. Medical Research Council. Developing and evaluating complex interventions: new guidance. 2006 [cited 2017 Dec 11]; Available from: www.mrc.ac.uk/complexinterventionsguidance

FUNDING

CACHET icon
FitMum is funded by CACHET, The Independent Research Fond Denmark, Beckett-Fonden, Aase and Ejnar Danielsens Fond, Familien Hede Nielsens Fond, UCPH and Department of Gynecology and Obstetrics, Nordsjællands Hospital

Contact

Signe de Place Knudsen
PhD Student
Department of Biomedical Sciences

Contact

Bente Merete Stallknecht
Prorector, Professor
Department of Biomedical Sciences
+45 35 32 75 40
http://www.cachet.dk/research/phd-projects/fitmum-process-evaluation
16 FEBRUARY 2019