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Recruitment Strategies for a Randomised Controlled Trial Comparing Fast Versus Slow Weight Loss in Postmenopausal Women with Obesity—The TEMPO Diet Trial

1
The Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Sydney Medical School, Charles Perkins Centre, The University of Sydney, Camperdown, NSW 2006, Australia
2
Metabolism & Obesity Services, Royal Prince Alfred Hospital, Camperdown, NSW 2050, Australia
3
School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, TAS 7250, Australia
*
Authors to whom correspondence should be addressed.
These authors contributed equally to this work.
Healthcare 2018, 6(3), 76; https://doi.org/10.3390/healthcare6030076
Received: 12 June 2018 / Revised: 2 July 2018 / Accepted: 3 July 2018 / Published: 6 July 2018
(This article belongs to the Special Issue Dietary Management of Obesity)
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Abstract

Current research around effective recruitment strategies for clinical trials of dietary obesity treatments have largely focused on younger adults, and thus may not be applicable to older populations. The TEMPO Diet Trial (Type of Energy Manipulation for Promoting optimal metabolic health and body composition in Obesity) is a randomised controlled trial comparing the long-term effects of fast versus slow weight loss on body composition and cardio-metabolic health in postmenopausal women with obesity. This paper addresses the recruitment strategies used to enrol participants into this trial and evaluates their relative effectiveness. 101 post-menopausal women aged 45–65 years, with a body mass index of 30–40 kg/m2 were recruited and randomised to either fast or slow weight loss. Multiple strategies were used to recruit participants. The total time cost (labour) and monetary cost per randomised participant from each recruitment strategy was estimated, with lower values indicating greater cost-effectiveness and higher values indicating poorer cost-effectiveness. The most cost-effective recruitment strategy was word of mouth, followed (at equal second place) by free publicity on TV and radio, and printed advertorials, albeit these avenues only yielded 26/101 participants. Intermediate cost-effective recruitment strategies were flyer distribution at community events, hospitals and a local tertiary education campus, internet-based strategies, and clinical trial databases and intranets, which recruited a further 40/101 participants. The least cost-effective recruitment strategy was flyer distribution to local health service centres and residential mailboxes, and referrals from healthcare professionals were not effective. Recruiting for clinical trials involving postmenopausal women could benefit from a combination of recruitment strategies, with an emphasis on word of mouth and free publicity via radio, TV, and print media, as well as strategic placement of flyers, supplemented with internet-based strategies, databases and intranets if a greater yield of participants is needed. View Full-Text
Keywords: weight loss; clinical trial; diet—reducing; recruitment; obesity weight loss; clinical trial; diet—reducing; recruitment; obesity
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Hsu, M.S.; Harper, C.; Gibson, A.A.; Sweeting, A.N.; McBride, J.; Markovic, T.P.; Caterson, I.D.; Byrne, N.M.; Sainsbury, A.; Seimon, R.V. Recruitment Strategies for a Randomised Controlled Trial Comparing Fast Versus Slow Weight Loss in Postmenopausal Women with Obesity—The TEMPO Diet Trial. Healthcare 2018, 6, 76.

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