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Despite recommendations to do so, few clinical trials focus on ethnic minority groups. There are concerns that data from general trials may not apply to them. PODOSA (Prevention of Diabetes and Obesity in South Asians) is a rare example of a prevention trial in European South Asians. The prevalence of type 2 diabetes among UK South Asian adults is extremely high.
Objectives of the Trial
To assess the feasibility and cost-effectiveness of the PODOSA lifestyle intervention (see below).
PODOSA is a cluster randomised controlled trial evaluating a family based, ethnically tailored, lifestyle intervention aiming to reduce the incidence of diabetes in people of Indian and Pakistani origin by reducing weight and increasing physical activity. Recruitment is via several channels. Eligible participants are those found to have impaired glucose levels (and therefore at high risk of developing diabetes) on an oral glucose tolerance test. The intervention group receives 15 contacts with a dietician over three years. The control group has 4 dietetic contacts. The dieticians’ toolkit contains culturally tailored resources on diet and exercise.
Recruitment commenced in July 2007 and plans to finish around August 2009. The trial has enjoyed support from individuals, community and religious organisations, media, leaders and health professionals. 122 families, with 135 people at high risk of diabetes and 101 family volunteers, have been recruited at the time of writing. Recruitment into the screening component of the trial has been slow, taxing and expensive. Referrals from NHS professionals have been few, and responses to radio, newspaper and website based publicity trivial. The response to written invitations has also been low. Face-to-face recruitment both with individuals and groups, has proved successful. 95% of those eligible have entered the trial.
The trial is challenging, both in terms of recruitment, and motivating behaviour change. The presentation will elaborate on the recruitment experience into a trial evaluating the effectiveness of interventions in ethnic minority populations.
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