Recruitment for phase II of the Trials of Hypertension Prevention. Effective strategies and predictors of randomization. Trials of Hypertension Prevention (TOHP) Collaborative Research Group

Ann Epidemiol. 1995 Mar;5(2):140-8. doi: 10.1016/1047-2797(94)00058-2.

Abstract

Phase II of the Trials of Hypertension Prevention is a multicenter, randomized, controlled trial designed to determine the efficacy of weight loss and reduction of sodium intake for lowering blood pressure and incidence of hypertension among persons with high-normal levels of blood pressure. The 2 x 2 factorial study design includes weight loss alone, restricted sodium intake alone, the combination of weight loss and sodium restriction, and a control group. Nine clinical centers used a variety of recruitment strategies to enroll 2382 participants over 17 months, which exceeded the sample size goal of 2250. Among randomized participants, 21% were minorities and 34% were women. Overall, direct mail generated the most randomized participants (73%), followed by community screening (12%) and media advertisement (11%). Referrals from community health care providers yielded few participants. Prescreening improved overall efficiency and reduced costs. Participants who were more likely to drop out voluntarily during the three-visit screening regimen tended to be younger, single, male, smokers, and less educated.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Blood Pressure
  • Combined Modality Therapy
  • Diet, Sodium-Restricted*
  • Female
  • Humans
  • Hypertension / drug therapy*
  • Hypertension / epidemiology
  • Hypertension / prevention & control*
  • Incidence
  • Male
  • Middle Aged
  • Oregon / epidemiology
  • Patient Dropouts
  • Patient Participation
  • Patient Selection*
  • Research Design
  • Weight Loss*