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

Karla Canuto, Robyn McDermott, Margaret CARGO

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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. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12610000224022).

Original languageEnglish
Article number77
Pages (from-to)1-10
Number of pages10
JournalInternational Journal for Equity in Health
Volume13
Issue number1
DOIs
Publication statusPublished - Oct 2014
Externally publishedYes

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Random Allocation
Randomized Controlled Trials
Research
Interviews
Waist Circumference
Vulnerable Populations
New Zealand
Registries
Research Design
Clinical Trials
Control Groups
Health

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title = "Participant views on participating in a pragmatic randomised controlled trial: The Aboriginal and Torres Strait Islander Women's Fitness Program",
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. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12610000224022).",
keywords = "Aboriginal and Torres Strait Islander, Physical activity, Pragmatic RCTs, Qualitative research, Randomisation, Women's Health, Humans, Middle Aged, Vulnerable Populations, Waist Circumference, Adult, Female, Interviews as Topic, Physical Fitness, Research Subjects/psychology, Australia, Oceanic Ancestry Group",
author = "Karla Canuto and Robyn McDermott and Margaret CARGO",
year = "2014",
month = "10",
doi = "10.1186/s12939-014-0077-3",
language = "English",
volume = "13",
pages = "1--10",
journal = "International Journal for Equity in Health",
issn = "1475-9276",
publisher = "BioMed Central",
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TY - JOUR

T1 - Participant views on participating in a pragmatic randomised controlled trial: The Aboriginal and Torres Strait Islander Women's Fitness Program

AU - Canuto, Karla

AU - McDermott, Robyn

AU - CARGO, Margaret

PY - 2014/10

Y1 - 2014/10

N2 - 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. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12610000224022).

AB - 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. Trial registration: Australian New Zealand Clinical Trials Registry (ACTRN12610000224022).

KW - Aboriginal and Torres Strait Islander

KW - Physical activity

KW - Pragmatic RCTs

KW - Qualitative research

KW - Randomisation

KW - Women's Health

KW - Humans

KW - Middle Aged

KW - Vulnerable Populations

KW - Waist Circumference

KW - Adult

KW - Female

KW - Interviews as Topic

KW - Physical Fitness

KW - Research Subjects/psychology

KW - Australia

KW - Oceanic Ancestry Group

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SN - 1475-9276

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