Recruitment of precarious families in an interventional study: Lessons from the French “Fruits and vegetables at home” (FLAM) trial

Abstract

BackgroundThe FLAM study was set up in order to assess the effectiveness of FV vouchers allowed to low-income households, on their FV consumption. The aim of the present study was to investigate issues associated with conducting interventional trials in disadvantaged populations using the FLAM study as an example of reaching target populations and recruitment difficulties.MethodsFamilies were recruited in Saint-Denis city (North Paris suburb), via social and municipal structures. Main interest variables in the study (food consumptions) were collected using face-to-face food interviews, either at home or municipal facilities. A qualitative analysis was performed among people who refused to participate in order to understand the barriers to participation.ResultsA total of 95 parents-child pairs were included from May 2015 to May 2016. The families were mostly in precarious situation (63.3%), and most of parents were unemployed (71.3%). Almost the two third of children and 79.4% of parents were small consumers of FV (less than 3.5 servings per day). Several reasons for non-participation were reported including time constraints, understanding and mistrust issues.ConclusionsThough using facilitating strategies, we recruited fewer participants than expected. The population finally included was mainly made of precarious families with a low consumption of FV. These results highlight the importance of identifying effective facilitating strategies to improve recruitment in disadvantaged populations.Trial registrationClinicalTrial.gov no. NCT02461238, on June 3, 2015, retrospectively registered.

Facilitators and barriers of children's participation in nutrition, physical activity, and obesity interventions: A systematic review

“…Seven were qualitative studies (which included interviews or focus groups with potential participants to inform a future clinical trial) 29–35 . Lastly, 16 studies applied mixed methods (which included the review of study records to evaluate recruitment and/or supplementary interviews, focus groups, surveys, or questionnaires about recruitment) 36–51 . Fifteen studies questioned parents and children about the facilitators and/or barriers to engaging in clinical trials, 29–33,41–49,52 and within these, only three studies assessed perceptions of both parents and children 47,48,52 .…”

“…Lastly, 16 studies applied mixed methods (which included the review of study records to evaluate recruitment and/or supplementary interviews, focus groups, surveys, or questionnaires about recruitment) 36–51 . Fifteen studies questioned parents and children about the facilitators and/or barriers to engaging in clinical trials, 29–33,41–49,52 and within these, only three studies assessed perceptions of both parents and children 47,48,52 . Also, 15 studies questioned research staff 25–28,34–40,44,46,50,51 .…”

“…Sample size varied from 37 to 1,879 in the mixed methods studies, 23–306 in quantitative studies, and 16–1,355 in qualitative studies. Lastly, 16 studies were conducted in the United States, 25–28,30,33,35,37–40,44,45,48,50,52 nine in Europe, 29,31,34,41–43,46,47,49 two in Australia, 32,51 and one in Canada 36 …”

Impact of fruits and vegetables vouchers on food insecurity in disadvantaged families from a Paris suburb

“…The percentage of people lost to follow-up was estimated to be about 40%, and the calculation took into account a type I error of 5% and with an expected power of 90%, leading to an expected number of participants of 300. Despite a wide range of recruitment strategies [45], we finally included 92 parent-child pairs, including 47 in the control group and 45 in the intervention group.…”