title: Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: results and lessons learned.
abstract: BACKGROUND
  Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status. Recruitment and retention of these populations in research trials, and retention in weight loss trials has been an ongoing challenge.
  
  
  METHODS
  Be Fit, Be Well was a pragmatic randomized weight loss and hypertension management trial of patients attending one of three community health centers in Boston, Massachusetts. Participants were asked to complete follow-up assessments every 6-months for two years. We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention. We also identify baseline participant characteristics associated with retention status. Retention strategies included financial incentives, contact between assessment visits, building relationships with health center primary care providers (PCPs) and staff, and putting participant convenience first.
  
  
  RESULTS
  Active refusal rates were low with 130 of 2,631 patients refusing participation (4.9%). Of 474 eligible persons completing telephone screening, 365 (77.0%) completed their baseline visit and were randomized into the study. The study population was predominantly non-Hispanic Black (71.2%), female (68.5%) and reported annual household income of less than $35,000 (70.1%). Recruitment strategies included use of passive approval of potential participants by PCPs, use of part-time staff, and outsourcing calls to a call center. A total of 314 (86.0%) people completed the 24-month visit. Retention levels varied across study visits and intervention condition. Most participants completed three or more visits (69.6%), with 205 (56.2%) completing all four. At 24-months, lower retention was observed for males and the intervention condition. Retention strategies included building strong relationships with clinic staff, flexibility in overcoming participant barriers through use of taxi vouchers, night and weekend appointments, and keeping participants engaged via newsletters and social gatherings.
  
  
  CONCLUSIONS
  We were able to retain 86.0% of participants at 24-months. Recruitment and retention of high percentages of racial/ethnic minorities and lower income samples is possible with planning, coordination with a trusted community setting and staff (e.g. community health centers and RAs), adaptability and building strong relationships.
  
  
  BACKGROUND
  Clinicaltrials.gov Identifier: NCT00661817.
authors.affiliation: Department of Epidemiology, Harvard School of Public Health, 677 Huntington Ave, Boston, MA, USA. ewarner@hsph.harvard.edu
authors.forename: Erica T
authors.initials: ET
authors.lastname: Warner
authors.forename: Russell E
authors.initials: RE
authors.lastname: Glasgow
authors.forename: Karen M
authors.initials: KM
authors.lastname: Emmons
authors.forename: Gary G
authors.initials: GG
authors.lastname: Bennett
authors.forename: Sandy
authors.initials: S
authors.lastname: Askew
authors.forename: Bernard
authors.initials: B
authors.lastname: Rosner
authors.forename: Graham A
authors.initials: GA
authors.lastname: Colditz
mesh_terms: D001741:Black or African American / Q000706:statistics & numerical data; D000368:Aged; D001900:Boston; D003151:Community Health Centers / Q000458:organization & administration* / Q000706:statistics & numerical data*; D005260:Female; D005500:Follow-Up Studies; D006630:Hispanic or Latino / Q000706:statistics & numerical data; D006801:Humans; D006973:Hypertension / Q000208:ethnology / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000208:ethnology / Q000517:prevention & control*; D010358:Patient Participation / Q000706:statistics & numerical data*; D018579:Patient Selection; D011203:Poverty / Q000706:statistics & numerical data; D015397:Program Evaluation; D013997:Time Factors; D061217:Weight Reduction Programs / Q000706:statistics & numerical data*