Recruitment of older adults with type 2 diabetes into a community-based exercise and nutrition randomised controlled trial.

Eliza G Miller,Deborah A Kerr,David Menzies,David W Dunstan,Vicky Solah,Robin M Daly,Caryl A Nowson

doi:10.1186/s13063-016-1589-5

Abstract

BackgroundRecruitment of participants into long-term community-based lifestyle intervention trials, particularly adults with a chronic disease, is often slow and challenging. Currently there is limited data on successful recruitment strategies suitable for older adults with type 2 diabetes into community-based exercise and nutrition programs, and no information on cost estimates associated with such recruitment. The aim of this report is to describe the recruitment strategies used and the success of each approach in recruiting older adults with type 2 diabetes into a 6-month community-based exercise and nutritional supplementation randomised controlled trial (RCT). A secondary aim is to assess the costs associated with the recruitment methods used.MethodsThe Resistance Exercise, Vitamin D and Muscle Protein Intervention Trial (REVAMP-IT) for type 2 diabetes is a 24-week RCT targeting 202 adults with type 2 diabetes which is designed to evaluate whether post-exercise ingestion of a whey- protein and vitamin D-enriched drink can enhance the effects of progressive resistance training (PRT) on glycaemic control, body composition and cardiometabolic health. Participants in this trial were randomly allocated to either: (1) the Lift for Life® community-based PRT program combined with additional whey protein and vitamin D, or (2) the Lift for Life® PRT program alone. Recruitment strategies included state and local newspaper and radio advertisements, targeted mail-outs, doctor and allied health referrals, community presentations, web-based media and word of mouth. The number of expressions of interest, participants screened and included in the trial, and how they first heard about the study were recorded by research staff during the screening process. Reasons for ineligibility or non-participation in the trial were also recorded as was the cost of each recruitment method used.ResultsA total of 1157 expressions of interest were received over a 21-month recruitment period. Overall 959 (83 %) individuals were screened and found to be ineligible for the trial or chose not to participate or could not be contacted further following their initial enquiry. As a result, 198 participants were randomised to the 24-week intervention. The most effective recruitment strategies were targeted mass mail-outs (39 % of the total participant sample), state (27 %) and local (14 %) print media. In total recruitment expenditure was AUD$40,421, which equated to AUD$35 per enquiry and AUD$204 per eligible participant. Targeted mail-outs and state print media were the most expensive strategies each accounting for 38 % of total expenditure.ConclusionsTo recruit around 200 older adults with type 2 diabetes into a community-based lifestyle intervention trial in a timely manner, it is important to ensure that an adequate budget is allocated to recruitment as targeted mail-outs and state/local print media were the most costly but effective strategies.Trial registrationAustralian New Zealand Clinical Trials Registry reference ACTRN12613000592741. Registered on 27 May 2013.

Highlights

Recruitment of participants into long-term community-based lifestyle intervention trials, adults with a chronic disease, is often slow and challenging
The Resistance Exercise, Vitamin D and Muscle Protein Intervention Trial (REVAMP-IT for type 2 diabetes) is a large-scale randomised controlled trial (RCT) involving 202 adults with type 2 diabetes designed to evaluate whether post-exercise ingestion of a whey-protein and vitamin D-enriched drink can enhance the effects of progressive resistance training (PRT) on glycaemic control, body composition and cardiometabolic health
1157 Expression of interest (EOI) were received from which 198 older adults with type 2 diabetes were deemed eligible for the trial and subsequently randomised

Summary

Introduction

Recruitment of participants into long-term community-based lifestyle intervention trials, adults with a chronic disease, is often slow and challenging. The aim of this report is to describe the recruitment strategies used and the success of each approach in recruiting older adults with type 2 diabetes into a 6-month community-based exercise and nutritional supplementation randomised controlled trial (RCT). One of the key challenges associated with conducting intervention trials, those that target populations with specific medical conditions such as people with type 2 diabetes, is finding the appropriate balance between recruitment of an adequate number of participants within monetary budgets and established timelines. Despite compelling evidence that exercise and diet are key elements in the management (and prevention) of type 2 diabetes, individuals with this condition are typically inactive and have poor dietary habits [1, 2] It is often difficult for these people to commit to a long-term behavioural change program that is central to these types of studies. Common barriers and reasons that have been identified for why many adults (including those with type 2 diabetes) do not participate in exercise trials include inconvenience, a lack of time to dedicate when managing work/family commitments and a lack of understanding of the potential health benefits of participating in such trials [3, 4]

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