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Recruitment and retention of WIC participants in a longitudinal dietary intervention trial.

ABSTRACT: Background:This paper describes strategies and outcomes of techniques to recruit and retain low-income women served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in a longitudinal dietary intervention trial. Methods:Community engagement strategies, methods to recruit and retain participants, and recruitment and retention rates are reported. Demographic and lifestyle predictors of loss to follow-up, contacts required to reach participants at each data collection point, participant reactions to the recruitment and retention strategies used, and reasons for drop out (assessed among those who discontinued their study involvement) also were examined. Results:Of 1281 eligible women, 744 were enrolled (58% recruitment rate); retention rates were 87%, 70%, and 55%, respectively, 2 weeks and 3 and 6 months post-intervention. Being unmarried, younger, and having low baseline vegetable intake predicted loss to follow-up. Between 4 and 5 contact attempts and 1 and 2 completed contacts were required to reach participants at each data collection point. Participants endorsed recruiting women while waiting for WIC appointments (as they were accessible, perceived the information provided as informative, and wanted to pass the time) and by word of mouth. Lacking time and loss of interest were commonly reported reasons for not completing assessments and dropout. To improve retention, shortening telephone assessments, conducting the assessments in person, and increasing the amount of incentives were recommended. Conclusion:Despite using recommended strategies, recruitment and retention rates were modest. Research is needed to identify and test approaches to effectively engage WIC-enrolled adults in health intervention trials.

SUBMITTER: Di Noia J

PROVIDER: S-EPMC6744523 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature

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Recruitment and retention of WIC participants in a longitudinal dietary intervention trial.

Di Noia Jennifer J Schultz Stephanie S Monica Dorothy D

Contemporary clinical trials communications 20190906

<h4>Background</h4>This paper describes strategies and outcomes of techniques to recruit and retain low-income women served by the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in a longitudinal dietary intervention trial.<h4>Methods</h4>Community engagement strategies, methods to recruit and retain participants, and recruitment and retention rates are reported. Demographic and lifestyle predictors of loss to follow-up, contacts required to reach participants at e ...[more]

PMID: 31535056

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Project description: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.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.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.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.Clinicaltrials.gov Identifier: NCT00661817.

Project description:BackgroundWeb-based behavioral programs efficiently disseminate health information to a broad population, and online tailoring may increase their effectiveness. While the number of Internet-based behavioral interventions has grown in the last several years, additional information is needed to understand the characteristics of subjects who enroll in these interventions, relative to those subjects who are invited to enroll.ObjectiveThe aim of the study was to compare the characteristics of participants who enrolled in an online dietary intervention trial (MENU) with those who were invited but chose not to participate, in order to better understand how these groups differ.MethodsThe MENU trial was conducted among five health plans participating in the HMO Cancer Research Network in collaboration with the University of Michigan Center for Health Communication Research. Approximately 6000 health plan members per site, between the ages of 21 and 65, and stratified by gender with oversampling of minority populations, were randomly selected for recruitment and were mailed an invitation letter containing website information and a US$2 bill with the promise of US$20 for completing follow-up surveys. Administrative and area-based data using geocoding along with baseline survey data were used to compare invitees (HMO members sent the introductory letter), responders (those who entered a study ID on the website), and enrollees (those who completed the enrollment process). Generalized estimating equation multivariate and logistic regression models were used to assess predictors of response and enrollment.ResultsOf 28,460 members invited to participate, 4270 (15.0%) accessed the website. Of the eligible responders, 2540 (8.9%) completed the consent form and baseline survey and were enrolled and randomized. The odds of responding were 10% lower for every decade of increased age (P < .001), while the likelihood of enrolling was 10% higher for every decade increase in age (P < .001). Women were more likely to respond and to enroll (P < .001). Those living in a census tract associated with higher education levels were more likely to respond and enroll, as well as those residing in tracts with higher income (P < .001). With a 22% (n = 566) enrollment rate for African Americans and 8% (n = 192) for Hispanics, the enrolled sample was more racially and ethnically diverse than the background sampling frame.ConclusionsRelative to members invited to participate in the Internet-based intervention, those who enrolled were more likely to be older and live in census tracts associated with higher socioeconomic status. While oversampling of minority health plan members generated an enrolled sample that was more racially and ethnically diverse than the overall health plan population, additional research is needed to better understand methods that will expand the penetration of Internet interventions into more socioeconomically diverse populations.Trial registrationClinicaltrials.gov NCT00169312; http://clinicaltrials.gov/ct2/show/NCT00169312 (Archived by WebCite at http://www.webcitation.org/5jB50xSfU).

Project description:Background/aimsEfficient and effective participant recruitment is key for successful clinical research. Adolescent and emerging adult recruitment into clinical trials can be particularly challenging, especially when targeting underrepresented groups. This study aimed to determine the most successful recruitment strategies from those employed during a pediatric trial testing the efficacy of a behavioral intervention on adiposity and cardiovascular disease risk.MethodsWe determined the effectiveness, cost, and diversity of the final research population by each recruitment method utilized in the EMPower trial, a randomized clinical trial designed to test the effect of a technology-delivered behavioral Healthy Lifestyle intervention on adiposity, blood pressure, and left ventricular mass among adolescents and emerging adults with overweight or obesity. Effectiveness was determined by respondent yield (RY; number of respondents/number contacted), scheduled yield (SY; number scheduled for a baseline visit/number of respondents), enrollment yield (EY; number enrolled/number of respondents), and retention (number completed/number enrolled). Cost-effectiveness of each recruitment method was calculated and demographics of participants recruited via each method was determined.ResultsA minimum of 109,314 adolescents and emerging adults were contacted by at least one recruitment method (clinic, web-based, postal mailing, electronic medical record (EMR) messaging) leading to 429 respondents. The most successful strategies in terms of RY were clinic-based recruitment (n = 47, 61% RY), community web-postings (n = 109, 5.33% RY), and EMR messaging (n = 163, 0.99% RY); however, website, postal mailings, and EMR recruitment led to more successful SY and EY. Postal mailings were the most costly strategy to employ (US$3261/completed participant) with EMR messaging the second most costly (US$69/completed participant). Community web-postings were free of charge. Clinic-based recruitment did not add additional costs, per se, but did require a substantial amount of personnel time (63.6 h/completed participant). Final cohort diversity primarily came from postal mailings (57% Black) and EMR messages (50% female).ConclusionElectronic medical record messaging and web-based recruitment were highly successful and cost-effective strategies in a pediatric clinical trial targeting adolescents and emerging adults, but was less successful in recruiting a diverse cohort. Clinic recruitment and postal mailings, despite being costly and time-consuming, were the strategies that enrolled a greater proportion of underrepresented groups. While online forms of trial recruitment are growing in popularity, clinic-based recruitment and non-web-based strategies may be required to ensure participant diversity and representation.

Project description:BackgroundWe discuss barriers to recruitment, retention, and intervention delivery in a randomized controlled trial (RCT) of patients presenting with firearm injuries to a Level 1 trauma center. The intervention was adapted from the Critical Time Intervention and included a six-month period of support in the community after hospital discharge to address recovery goals. This study was one of the first RCTs of a hospital- and community-based intervention provided solely among patients with firearm injuries.Main textBarriers to recruitment included limited staffing, coupled with wide variability in length of stay and admission times, which made it difficult to predict the best time to recruit. At the same time, more acutely affected patients needed more time to stabilize in order to determine whether eligibility criteria were met. Barriers to retention included insufficient patient resources for stable housing, communication and transportation, as well as limited time for patients to meet with study staff to respond to follow-up surveys. These barriers similarly affected intervention delivery as patients who were recruited, but had fewer resources to help with recovery, had lower intervention engagement. These barriers fall within the broader context of system avoidance (e.g., avoiding institutions that keep formal records). Since the patient sample was racially diverse with the majority of patients having prior criminal justice system involvement, this may have precluded active participation from some patients, especially those from communities that have been subject to long and sustained history of trauma and racism. We discuss approaches to overcoming these barriers and the importance of such efforts to further implement and evaluate hospital-based violence intervention programs in the future.ConclusionDeveloping strategies to overcome barriers to data collection and ongoing participant contact are essential to gathering robust information to understand how well violence prevention programs work and providing the best care possible for people recovering from injuries.Trial registrationClinicalTrials.gov NCT02630225 . Registered 12/15/2015.

Project description:BACKGROUND:Recruitment of research participants poses challenges in socioeconomically deprived areas. The Awareness and Beliefs About Cancer (ABACus) phase 3 Randomised Control Trial recruited adult participants from socioeconomically deprived areas using a combined healthcare/community engagement model. We report the strategies used to successfully recruit and retain our trial participant sample. METHODS:Community and healthcare settings in areas of high socioeconomic deprivation were identified by lay advisors who recruited participants opportunistically or by appointment. Follow-up was done by telephone or post at 2-weeks and 6-months after recruitment, and all participants were offered financial incentives. Qualitative interviews were conducted with lay advisors regarding their experience and reflections. RESULTS:The lay advisors identified and contacted 107 potential recruitment venues across South and West Yorkshire and South East Wales of which 41.1% (n?=?42) were opened for recruitment. A total of 234 participants were recruited, with 91% (n?=?212) retention at 2-weeks and 85% (n?=?199) at 6-months. Community settings yielded 75% (n?=?176) of participants. Participants had a mean age of 61.3?years and 63.3% (n?=?148) were female, with 66% (n?=?154) resident in the most deprived geographical areas. Lay advisors described recruitment as intensive, although engaging participants was easier in community settings. CONCLUSIONS:The ABACus3 trial achieved recruitment and high retention with a population that is often "hard to reach" or entirely missed in health research. Strategies were specifically tailored to engage the venues and adult residents of highly deprived areas. Future studies recruiting adults living in the most deprived areas might benefit from community recruitment and from collaborating with local gatekeepers who are key to engagement. This study adheres to CONSORT guidelines. TRIAL REGISTRATION:Retrospectively registered with ISRCTN ( http://www.isrctn.com/ISRCTN16872545 ) on 12.01.2018.

Project description:Background and aimThe recruitment process in a randomized trial can be challenging. Poor recruitment can have a negative impact on the allocated budget and estimated completion date of the study and may result in an underpowered study. We aimed to perform a Study Within A Trial (SWAT) to evaluate the impact of same-day consent or delayed consent on recruitment and retention in the host trial.MethodsThis SWAT is designed as a prospective cohort design. The host trial was a randomized controlled trial evaluating the effectiveness of an intensive lifestyle modification programme in participants with peripheral arterial disease. Researchers screened the participants for inclusion and exclusion criteria. Informed consents were obtained from the participants who were willing to participate in the study on a standardized consent form. Participants were given the option to consent on the same day or to delay their consent. Following the consent, the participants were allocated to two groups (same-day consent vs. delayed consent) based on pre-determined criteria for SWAT. One hundred sixteen participants were consented to take part in the host trial. Seventy-five participants were randomized to the host trial. The primary outcome was the proportion of participants who withdrew consent at the recruitment phase. Secondary outcomes were reasons for consent withdrawal and dropout, attrition rate, and adherence with the host trial intervention.ResultsThere was a significantly lower consent-withdrawal rate in same-day consent (17.4%, n = 8/46), compared to the delayed consent group (47.1%, n = 33/70), p = 0.001. There was a significantly lower dropout rate in participants randomized following same-day consent (10.5%, n = 4/38), compared to those randomized after delayed consent (29.7%, n = 11/37), p = 0.038. Transport was the main reason mentioned for consent withdrawal and dropout. In participants randomized to the host trial intervention arm, there was a significant difference in adherence (percentage of the 12-week programme completed) between same-day consent (96.7% ± 4.9) and delayed consent participants (86.4% ± 11.2), p = 0.003, as well as number of weeks completed (mean difference = - 1.547, 95% confidence intervals (- 2.237 to - 0.85)), p = 0.02.ConclusionThis SWAT found evidence that participants who gave consent on the same day seemed to have better adherence and fewer-withdrawal and dropout rates.Swat registrationThe SWAT was registered on the Northern Ireland Network for Trials Methodology Research, SWAT 84.

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Recruitment and retention of WIC participants in a longitudinal dietary intervention trial.

Publications

Recruitment and retention of WIC participants in a longitudinal dietary intervention trial.

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