Participant views on participating in a pragmatic randomised controlled trial: the Aboriginal and Torres Strait Islander Women's Fitness Program

Canuto, Karla, McDermott, Robyn, and Cargo, Margaret (2014) Participant views on participating in a pragmatic randomised controlled trial: the Aboriginal and Torres Strait Islander Women's Fitness Program. International Journal for Equity in Health, 13. 77. pp. 1-10.

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Abstract

Introduction: The inequity of randomising participants to control groups in randomised controlled trials (RCTs) is often considered inappropriate, especially for research trials that include vulnerable populations such as Indigenous peoples. The Aboriginal and Torres Strait Islander Women's Fitness Program conducted a trial that randomly assigned participants to 'active' and 'waitlisted' groups. This paper reports on participant views of the randomisation protocol.

Methods: A pragmatic RCT was conducted in an urban setting to assess the effectiveness of the 12-week Aboriginal and Torres Strait Islander Women's Fitness Program on metabolic health outcomes and waist circumference. Qualitative interviews were conducted at follow-up, one of the objectives was to explore participant perspectives on the research protocol, including participant randomisation to 'Active' and 'Waitlisted' groups.

Results: A total of 49 interviews were conducted (26 Active and 23 Waitlisted participants). Two key factors influenced participant views on the protocol: 1) group assignment; and 2) how well they understood the research design, including the justification for randomisation. 'Active' participants were concerned about the inequity of the randomisation process but overall supported the study protocol. Although most Waitlisted participants were disappointed about having to wait 12-months for the program, some participants derived motivation from being waitlisted, whilst others lost motivation. Well-informed participants were more likely to express both support for the randomisation process and an understanding of the research benefits than participants not attending an information session prior to registration.

Conclusions Participants were more accepting of the research protocol if it was clearly explained to them, if they understood the randomisation process and felt the randomisation was justified in terms of the potential for the results to benefit other Aboriginal and Torres Strait Islander women. Our study suggests that the time and resources required to adequately explain the research protocol in research trials should not be undervalued.

Item ID: 36814
Item Type: Article (Research - C1)
ISSN: 1475-9276
Keywords: pragmatic RCTs, qualitative research, Aboriginal and Torres Strait Islander, physical activity, randomisation
Additional Information:

© 2014 Canuto et al.; licensee BioMed Central Ltd.

This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. 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.

Funders: National Health and Medical Research Council (NHMRC), Australian Research Council (ARC)
Projects and Grants: NHMRC grant number 570111, NHMRC Scholarship ID 456402, ARC Future Fellowship FT100100312, NHMRC Practictioner Research Fellowship number 1003375
Date Deposited: 12 Mar 2015 02:35
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111701 Aboriginal and Torres Strait Islander Health @ 100%
SEO Codes: 92 HEALTH > 9203 Indigenous Health > 920303 Aboriginal and Torres Strait Islander Health - Health System Performance (incl. Effectiveness of Interventions) @ 50%
92 HEALTH > 9202 Health and Support Services > 920205 Health Education and Promotion @ 50%
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