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Recruitment and retention in obesity prevention and treatment trials targeting minority or low-income children: a review of the clinical trials registration database

  • Zhaohui Cui1,
  • Elisabeth M. Seburg2,
  • Nancy E. Sherwood2,
  • Myles S. Faith1 and
  • Dianne S. Ward1Email author
Trials201516:564

https://doi.org/10.1186/s13063-015-1089-z

Received: 25 April 2015

Accepted: 27 November 2015

Published: 10 December 2015

Abstract

Background

Efforts to recruit and retain participants in clinical trials are challenging, especially in studies that include minority or low-income children. To date, no studies have systematically examined recruitment and retention strategies and their effectiveness in working successfully with this population. We examined strategies employed to recruit or retain minority or low-income children in trials that included an obesity-related behavior modification component.

Methods

First, completed home-, community-, and school-based trials involving minority or low-income children aged 2–17 years were identified in a search of the ClinicalTrials.gov registry. Second, a PubMed search of identified trials was conducted to locate publications pertinent to identified trials. Recruitment and retention rates were calculated for studies that included relevant information.

Results

Our final analytic sample included 43 studies. Of these, 25 studies reported recruitment or retention strategies, with the amount of information varying from a single comment to several pages; 4 published no specific information on recruitment or retention; and 14 had no publications listed in PubMed. The vast majority (92 %) of the 25 studies reported retention rates of, on average, 86 %. Retention rates were lower in studies that: targeted solely Hispanics or African Americans (vs. mixed races of African Americans, whites, and others); involved children and parents (vs. children only); focused on overweight or obese children (vs. general children), lasted ≥1 year (vs. <1 year), were home or community-based (vs. school-based), included nutrition and physical activity intervention (vs. either intervention alone), had body mass index or other anthropometrics as primary outcome measures (vs. obesity-related behavior, insulin sensitivity, etc.). Retention rates did not vary based on child age, number of intervention sessions, or sample size.

Conclusions

Variable amounts of information were provided on recruitment and retention strategies in obesity-related trials involving minority or low-income children. Although reported retention rates were fairly high, a lack of reporting limited the available information. More and consistent reporting and systematic cataloging of recruitment and retention methods are needed. In addition, qualitative and quantitative studies to inform evidence-based decisions in the selection of effective recruitment and retention strategies for trials including minority or low-income children are warranted.

Keywords

African AmericanbehaviorchildrenHispanicinterventionlifestylelow incomerecruitmentretentionsystematic review

Background

Successful recruitment and retention are critical for evaluating intervention effectiveness in clinical trials that address childhood obesity. However, the recruitment and retention of participants is challenging, especially in clinical trials that involve ethnic minority or low-income populations in the prevention or treatment of childhood obesity. Problems in participant recruitment may lead to untimely delays in implementation, added financial burden, and failure to meet recruitment goals. Once participants have been recruited, maintaining their engagement across the course of the trial requires thoughtful planning, careful monitoring, and sometimes extraordinary efforts.

Recently, the National Heart, Lung, and Blood Institute convened a workshop to address recruitment and retention strategies in phase 3 and 4 clinical trials. In an article about this initiative, Probstfield and Frye [1] summarized critical steps that must be taken to ensure adequate participant enrollment and retention. These authors noted that trials that involve women and minority populations are more challenging and costly because of issues related to transportation, childcare, and individual and community acceptance. Moreover, reaching minority participants creates additional challenges.

Childhood obesity studies, both for prevention and treatment, present additional challenges related to participant recruitment and retention. Parents and caregivers are often not interested in or have little concern for obesity as a problem and may not recognize excess body weight, especially when it occurs in younger children [2, 3]. An added component of research involving children is that family participation, either direct or indirect, is required. Even when parents or other primary caregivers are not targeted as study participants, family members must provide consent, support, and coordination for the child’s participation in the research study. Thus, recruitment and retention of participants must consider the index child and a parent or guardian for study success.

Childhood obesity intervention trials, especially those conducted within community settings, offer great challenges for participant recruitment and retention because of the time required for baseline measures, intervention delivery, post-intervention testing, and measures of sustainability. Although successful recruitment and retention strategies have been generally described in studies focusing on adults [4] and children [3], no prior reviews have systematically assessed the recruitment and retention of minority or low-income children and families in obesity treatment and prevention studies. In addition, no studies have attempted to determine what information about recruitment and retention is provided in childhood obesity intervention studies following their completion. More information is needed about successful recruitment and retention strategies for interventions that involve minority or low-income children and families to provide researchers with needed information for better design and budgeting for research studies.

The United States Clinical Trials Registration Database (CTRD) offers an excellent study frame to address these issues. For this database, a clinical trial is defined as any research study that assigns human participants to interventions (e.g., a medical product, behavior, or procedure) to evaluate the effects on health outcomes [5]. In 2000, the United States CTRD (ClinicalTrials.gov) was established as an official web platform and catalog for registering a clinical trial. Run by the United States National Library of Medicine, ClinicalTrials.gov was the first online registry for clinical trials and is the largest and most widely used trial registry today. Part of the purpose of the CTRD is to make clinical trial information more widely available and to standardize information provided about trials. In 2005, the International Committee of Medical Journal Editors initiated the policy that trials will be considered for publication only if they were registered before submission [6]. This policy has been followed by a large number of journals [7]. The CTRD is accepted by the International Committee of Medical Journal Editors [6].

Because of the importance of recruitment and retention strategies, the increased participation of community intervention trials in the CTRD, and the provision of information on the trials’ process, a review of the recruitment and retention strategies of childhood obesity prevention and treatment intervention studies located within the database was undertaken. The purpose of the review was to glean collective information from the registered trials, which could be used to improve subsequent childhood obesity interventions and to enhance future recruitment and retention efforts. Specifically, this review aimed to (1) describe strategies employed to recruit minority participants to intervention trials targeting child diet, physical activity, or obesity-related outcomes and assess the success of these recruitment efforts; and (2) examine strategies used to retain participants in these intervention trials and evaluate retention success.

Methods

The CTRD was searched to identify ‘completed’ trials (as defined by CTRD) that contained information about recruitment and retention of child or adolescent participants in studies with diet, physical activity, or obesity-related outcomes on 6 March 2014. We included home-, community-, and school-based interventions with a behavioral intervention component. Inclusion criteria included: (a) ethnic minority or low-income children or adolescents as the intervention target; (b) diet, physical activity, or obesity-related outcome; (c) a completed trial; and (d) specific information on recruitment or retention numbers and strategies used. Studies were excluded if they tested a specialized diet, medication, dietary supplement, or monitoring device; studied infants (i.e., <2 years of age); or focused on an infectious disease outcome or illness other than obesity or diabetes.

Using the CTRD search engine, specific search terms used included: (underserved OR ‘hidden population’ OR uninsured OR minority OR low income OR Latino OR Latina OR Hispanic OR black OR African American OR Mexican American OR poverty OR vulnerable OR ethnic). Also within the CTRD search engine: the ‘Recruitment’ parameter was constrained to be ‘completed’; the ‘Study type’ parameter was constrained to ‘interventional studies’; the ‘Conditions’ parameter was constrained to (type 2 diabetes OR diabetes mellitus OR obesity OR overweight OR diet OR nutrition OR physical activity OR sedentary behavior); and the ‘Age group’ parameter was constrained to ‘Child (birth to 17 years)’.

As secondary sources of information on recruitment and retention, we searched within CTRD for pertinent papers associated with each identified study. In addition, a PubMed search was conducted using the following information: (CTRD number OR grant number OR intervention name noted in the CTRD) AND name of the principal investigator AND date of study start. All searches of the CTRD and PubMed were conducted by the first author (ZC) after consulting a university librarian assigned to services exclusively for public health research. The first author (ZC) read all of the registration information in an effort to identify appropriate studies. Studies that provided information on recruitment or retention numbers and strategies were retained. Data extraction was performed independently by two authors using tailored tables, and results were cross-checked for accuracy and completeness. Disagreements between the two authors were discussed and resolved in regular writing group meetings.

Results

Analytic sample and sample characteristics

A total of 98 studies were retrieved from our search of the CTRD (Fig. 1). Of these, 57 studies were excluded for the following reasons: drug trials (n = 10); special diet trials (n = 8); dietary supplement (n = 18); infectious disease (n = 3); monitoring device (n = 5); 2-day trial (n = 1); participants younger than 2 years (n = 9) or older than 17 years (n = 3). This yielded a total of 41 eligible studies. Search methods identified two additional papers that described studies that were linked to two of the 41 CTRD numbers but appeared to represent slightly different studies (different sample sizes). These were included as separate studies, bringing our final analytic sample total to 43 studies. Of these 43 studies, 29 had at least one published article in a peer-reviewed journal, with 25 having specific information on recruitment or retention of participants. One of the 25 studies (i.e., Girls Health Enrichment Multi-Site Studies or GEMS) included several articles published, from seven different study phases or sites.
Fig. 1

Flowchart for identification of studies and published papers

Characteristics of the 25 studies included in this review are described in Table 1. More than half of the studies were randomized controlled trials (n = 14); five were cluster randomized controlled trials; two were non-randomized controlled trials; and four were trials without a control group. Studies were conducted in various settings, including home or community, including county extension offices, YMCA and childcare centers (n = 11), schools (n = 7), clinics (n = 5), laboratories (n = 3). Categories are not mutually exclusive, as some studies had more than one setting. By design, all studies enrolled Hispanics or African Americans, but could have enrolled white participants. Eighty percent of the studies targeted both children and parents. More than 75 % of studies included both nutrition and physical activity intervention components. Two-thirds of the studies lasted less than 1 year. Most studies utilized body mass index (BMI, n = 11) or insulin sensitivity or blood glucose metabolism (n = 10) as the primary outcome measures, while others used physical activity or fitness (n = 5), body fat (n = 4), diet (n = 3) or adherence behaviors (n = 3).
Table 1

Characteristics of extracted studies

Reference and CTRD number

Participants

Intervention

Primary outcome

Child’s race or ethnicity

Child’s body weight status

Child’s age in years (sex)a

Parental participation

Setting

Focus

Length

Hasson et al. [14]

Black

Obese

15.4 ± 1.1

Yes

Laboratory

Nutrition, physical activity

16 weeks

Adiposity, inflammation, insulin sensitivity

NCT01441323

Davis et al. [15]

Hispanic

Overweight or obese

14–18

Yes

Laboratory

Nutrition, physical activity

16 weeks

Adiposity, insulin sensitivity

Ventura et al. [16]

NCT00697580

Azevedo et al. [17]

Hispanic

All weights

7–11

Yes

Not reported for dance; at home for TV time

Nutrition, physical activity

2 years

BMI

NCT00476775

Berry et al. [1820]b

Black (63 %), white (32 %), other (5 %)

Overweight or obese

7–10

Overweight or obese

School

Nutrition, physical activity

12 months

Child’s BMI percentile, parent BMI

NCT01378806

Elizondo-Montemayor et al. [21] c

Hispanic

Overweight or obese

6–12

Yes

School

Nutrition

1 school year

BMI percentile, dietary intake and eating habits

NCT01925976

Wang et al. [22, 23] b

Black

All weights

5–7th grade

No

School

Nutrition, physical activity

 

Feasibility of intervention

NCT00061165

Black et al. [24, 25]

Black

All weights

11–16

Yes

Home and community

Nutrition, physical activity

11 months

BMI

Hurley et al. [26]

Witherspoon et al. [27]

NCT00746083

Weigensberg et al. [28]

Hispanic

Obese

14–17

No

Not clear

Nutrition, physical activity, interactive guided imagery

12 weeks

Insulin sensitivity

NCT01895595

Wilson et al. 2011 [2931]b

Black (73 %), other

All weights

6th grade

No

School

Physical activity

17 weeks

Moderate-to-vigorous physical activity

NCT01028144

Naar-King et al. [32]

Black

Obese

12–17

Yes

Home

Nutrition, physical activity

6 months

BMI, overweight (%), percentage body fat

NCT00604981

Ritchie et al. [33]

Black

Overweight

9–10

Yes

YMCA

Nutrition, physical activity

4–9 seasons

Insulin sensitivity

Sharma et al. [34]d

NCT01039116

Eisenmann et al. [35]d

Hispanic or black

All weights

3rd–5th grade

Yes

School and community

Nutrition, physical activity

2 years

Physical activity, healthy eating index

NCT01385046

Barkin et al. [36]

Hispanic

All weights

2–6

Yes

Community recreation center

Nutrition, physical activity

12 weeks

BMI

NCT00808431

Burnet et al. [37]e

Black

Overweight or obese

9-12, with family history of type 2 diabetes mellitus

Yes

Community

Nutrition, physical activity

1 year

Child’s BMI z score, parent’s BMI, glucose tolerance

NCT00723853

Davis et al. [3840]

White (58 %), black (39 %), Hispanic (3 %)

Overweight or obese

7–11

No

Laboratory

Nutrition, physical activity

10–15 weeks

Risk of type 2 diabetes mellitus, VO2 max, percentage body fat, visceral fat

Tkacz et al. [41]

Petty et al. [42]

NCT00108901

Madsen et al. [43] b

Hispanic (42 %), Asian (32 %), black (12 %), white (0.6 %), other (13.4 %)

All weights

4th or 5th grade

No

School

Physical activity

24 weeks

Change in minutes of after-school moderate-to-vigorous physical activity, VO2 max, BMI

NCT01156103

Wickham et al. [44]

Black (70.3 %), white (26.1 %), Hispanic (1.8 %)

Obese

11–18

Yes

Weight management clinic

Nutrition, physical activity

2 years (results at 6 months reported)

BMI, metabolic indicators, fitness

NCT00167830

Bean et al. [45] e

Black (75.3 %), white (22.0 %), other (2.7 %)

Obese

11–18

Yes

Weight management clinic

Nutrition, physical activity

2 years (results at 6 months reported)

Dietary changes

NCT00167830

Wysocki et al. [46, 47]

White (78.2 %), black (21.0 %), Hispanic (0.8 %)

All weights

12–16.75 with type 1 diabetes mellitus

Yes

Treatment center

Parent–adolescent conflict

12 months (results at 3 months reported)

Family relationships, psychological adjustment to diabetes treatment, treatment adherence, diabetic control

NCT00358059

Wysocki et al. [4850]

White (63.5 %), black (30.8 %), Hispanic (2.9 %), other (2.9 %)

All weights

11–16, with type 1 diabetes mellitus

Yes

Pediatric center

Parent–adolescent conflict

6 months

Family relationships, treatment adherence, HbA1c, health care use

NCT00358059

Ellis et al. [51, 52]

Black (63 %), white (26 %), other (11 %)

All weights

10–17, with type 1 diabetes mellitus

Yes

Home, community

Home-based psychotherapy

Approximately 6 months

Adherence to medical regimen, metabolic control, hospital use

NCT00519935

Story et al. [2]

Black

Phase I: BMI ≥25th or ≥50th percentile;

8–10 (girls)

Overweight or obese

Community center, school, home

Nutrition, physical activity

Phase I: 12 weeks;

Phase I: process measures;

Rochon et al. [53]

Phase II: BMI ≥25th percentile but ≤35 kg/m2

Phase II: 2 years

Phase II: change in child’s BMI

Kumanyika et al. [54, 55]

Klesges et al. [56, 57]

Robinson et al. [58, 59]

Stockton et al. [60]

NCT00000615

Natale et al. [61] b

Hispanic (60 %), Haitian (15 %), black (12 %), white (2 %), other (11 %)

All weights

2–5

Yes

Childcare center

Nutrition, physical activity

2 years

Child’s BMI

NCT01722032

Nansel et al. [62]

White (75 %), Hispanic (10 %), black (9 %), other (6 %)

All weights

9–14.9, with type 1 diabetes mellitus

Yes

Pediatric endocrinology clinic

Diabetes management behavior

2 years

HbA1c

NCT00273286

Janicke et al. [63]

White (76.1 %), black (9.8 %), Hispanic (8.5 %), biracial (4.2 %)

Overweight or obese

8–14

Yes

County extension office

Nutrition, physical activity

16 weeks

Change in child’s BMI

Follansbee-Junger et al. [64]

Radcliff et al. [65]

NCT00248677

BMI body mass index

aIncluded both sexes if not specified

bCluster randomized clinical trial

cTrial without control group

dNon-randomized controlled trial

ePre-post study design

Recruitment rates and strategies

Recruitment information provided in the studies is described in Table 2. Of the 25 studies, 16 (64 %) did not report a recruitment target; 8 (32 %) did not report capture rate expressed as the ratio of participants who were enrolled to potential participants who were screened. When capture rate was included, it ranged from 10 % to 90 %. Eight (32 %) of the 25 studies did not report formative research information on recruitment. Only eight studies reported recruitment durations, which ranged from 2.5 months (enrolled approximately 60 girls) to 3 years (enrolled 235 children). Recruitment was primarily conducted in community, school, and primary care settings. Specific recruitment strategies were reported in only 14 studies, with the amount of information varying from a single comment to several pages. Common recruitment methods were presentations, flyers, brochures, posters, media advertisements, phone calls, and word-of-mouth. Two-thirds of studies did not report any information on barriers for recruitment. When barriers were reported, they included participants’ time constraints, competing demands, transportation safety and distance, childcare needs, lack of interest, and study funding limitations.
Table 2

Study recruitment: effectiveness, setting, strategies employed, and barriers reported

Reference

Sample size

Reach (% capture)

Formative research

Recruitment duration

Recruitment setting

Recruitment strategies

Recruitment barriers

Hasson et al. [14]

58 families

11.6

Yes

Davis et al. [15]

68 families

17.0

Yes

Ventura et al. [16]

Azevedo et al. [17]

252 families

Community

Berry et al. [1820]

358 parent–child dyads

27.5

Yes

2 years 9 months

School

1) Meeting with school staff

2) Printed study information

3) Presentation to children and parents

4) Printed study contact information

5) Friendly manner

Elizondo-Montemayor et al. [21]

125 caregiver–child dyads

9.6

School

Wang et al. [22, 23]

249 children

37.1

Yes

School

Black et al. [24, 25]

235 children

1 year 10 months

School

Hurley et al. [26]

Witherspoon et al. [27]

Weigensberg et al. [28]

35 adolescents

62.5

Yes

Pediatric clinics, health fairs

School vacation

Wilson et al. 2011 [2931]

1422 children

91.0

Yes

School and home

1) Presentation to parents and students

2) Home visit

Naar-King et al. [32]

49 families

69.0

Yes

An urban adolescent medicine clinic

1) Time constraint;

2) Lack of interest

Ritchie et al. [33]

235 families

Yes

3 years

School, community

1) Announcements

1) Transportation;

Sharma et al. [34]

2) Incentives

2) Competing demands;

3) Distrust;

Eisenmann et al. [35]

434 families

57.0

School

Barkin et al. [36]

106 parent–child dyads

22.2

4–5 months

Cooperating community agencies such as social service agencies, pediatric clinics, community centers

1) Printed study information

1) Transportation;

2) Radio

2) On-site childcare

3) Participant referral

Burnet et al. [37]

29 families

Yes

Community, pediatric clinics

Printed study information

Davis et al. [3840]

222 children

26.4 %

2 years 8 months

School

Printed study information

Tkacz et al. [41]

Petty et al. [42]

Madsen et al. [43]

156 children, six schools

11.7 % , 50 %, 89.7 %

Yes

School

Presentation to school staff

Change in school administration

Wickham et al. [44]

165 adolescents

2 years 4 months

Comprehensive weight management program

Healthcare provider referral

Bean et al. [45]

186 adolescents

Yes

2 years 11 months

Health care, school, community

Healthcare provider referral

Wysocki et al. [46, 47]

119 families

31.3 %

Yes

1) Transportation;

2) Time constraint

Wysocki et al. [4850]

104 families

23.9 %

Yes

Pediatric diabetes centers

1) Mailed invitation letter

Funding limitation

2) Phone call

Ellis et al. [51, 52]

127 adolescents

69.8 %

Yes

Endocrinology clinic

Story et al. [2]

Phase I: 35–61 girls;

Phase I : not reported;

Yes

Phase I: 2.5–4 monthsa;

Community churches, community centers, community events and school

1) Active placebo study group

Phase I:

Rochon et al. [53]

Phase II: 261–303 girls

Phase II: 48.1 %-65.4 %

Phase II: 17 months

2) Media adverts, stories, interviews

1) No-treatment control group;

Kumanyika et al. [54, 55]

3) Flyers to homes

2) Parents interested in both child health and self-esteem programs, while children interested in fun programs;

Klesges et al. [56, 57]

4) Presentations to families at community and school

3) Blood draw.

Robinson et al. [58, 59]

5) Separate consent for blood draw, which was not required for participation

Phase II:

Stockton et al. [60]

1) School vacation

2) Study staff issues

3) Study site locations

Natale et al. [61]

1105 children

Child care center

Nansel et al. [62]

390 families

69.1 %

 

Pediatric endocrinology clinics

Janicke et al. [63]

93 parent–child dyads

83.8 %

Yes

 

Community and school

1) Printed study information

Follansbee-Junger et al. [64]

2) Community presentations

Radcliff et al. [65]

3) Toll-free line

a11.7 % of screened schools, 50 % of eligible schools at principals’ meeting, 89.7 % of children

Retention rates and strategies

Table 3 shows the average retention rates from individual studies based on study characteristics. Of the 25 studies examined, 23 studies reported retention rates, with an average rate of 86 %. Studies solely targeting Hispanics or African Americans had lower average retention rates, of 82.8 % and 83.5 %, respectively, than those targeting both ethnic minority and white participants (92.1 %). Three studies included children only; the average retention rate from these studies was higher than the average retention rate from studies that involved both children and parents (91.1 % vs. 85.6 %). On average, studies that focused on overweight or obese children had lower retention rates than those that targeted children generally (79.6 % vs. 90.0 %). Accordingly, treatment studies had a lower average retention rate than prevention studies, especially when the intervention lasted over 1 year (74.0 % vs. 88.8 %). Overall, longer-term studies produced lower retention rates than shorter-term studies, especially for treatment studies (74.0 % for ≥ 1 year vs. 87.2 % for < 1 year). Interestingly, studies with BMI or anthropometrics as primary outcome measures had lower retention rates than studies with other primary outcome measures (e.g., obesity-related behavior, insulin sensitivity; 82.9 % vs. 89.0 %). Home- or community-based studies had lower retention rates than school-based studies (85.5 % vs. 91.7 %). Studies including both nutrition and physical activity intervention components tended to have lower retention rates than studies focusing solely on nutrition or physical activity (85.0 % vs. 92.8 %). Retention rates did not differ by the mean age of children (<12 years vs. ≥ 12 years), number of intervention sessions (≤12 vs. ≥13), or study sample size (<100 vs. ≥100).
Table 3

Average retention rates by study characteristics

 

Number of studies

Study enrollmenta

Study retentionb

Average retention rates

Race or ethnicity

 Hispanic

5

586

511

82.8

 African American

10

1331

1059

83.5

 African American, white and other

8

1927

1763

92.1

Intervention target

 Children

3

413

388

91.1

 Children and parent

20

3431

2945

85.6

Body weight status

 Overweight or obese

9

1581

1314

79.6

 All weights

10

1523

1334

90.0

 Body weight status not measured

4

740

685

92.6

Study type

 Prevention

10

1523

1334

90.0

 Treatment

13

2321

1999

83.6

Intervention length

 <1 year

16

1658

1461

88.6

 ≥1 year

7

2186

1872

81.1

Study type and treatment length

 Prevention <1 year

7

707

614

90.4

 Prevention ≥1 year

3

816

720

88.8

 Treatment <1 year

9

951

847

87.2

 Treatment ≥1 year

4

1073

873

74.0

Primary outcome

 BMI or anthropometrics

10

2342

2026

82.9

 Other (behavior, physiology, etc.)

13

1502

1307

89.0

Intervention settingc

 School

5

1273

1151

91.7

 Home or community

15

2410

2051

85.5

 Laboratory

2

126

102

81.1

Main intervention group

 Nutrition or physical activity

4

755

712

92.8

 Nutrition and physical activity

19

3089

2621

85.0

Study design

 Randomized controlled trial

19

2739

2440

89.3

 Cluster randomized controlled trial

2

745

656

75.6

 Controlled trial

1

235

136

57.9

 Trial without control

1

125

101

80.8

Mean age of childrend

 <12 years

15

2708

2333

86.2

 ≥12 years

8

1136

1000

86.7

Number of intervention sessionse

 ≤12

7

752

636

86.3

 ≥13

15

2840

2445

85.5

Sample size

 <100

9

493

435

86.9

 ≥100

14

3351

2898

86.0

aThe sum of numbers of participants enrolled in individual studies

bThe sum of numbers of participants retained in individual studies

cIntervention setting was not reported in the study by Weigensberg et al. [28]

d<12 years group includes one study with participants aged 8–14 years; ≥12 years group includes one study with participants aged 9–14 years, one study with participants aged 10–17 years and two studies with participants aged 11–16 years

eNumber of intervention sessions was not reported in the study by Azevedo et al. [17]

Of the 25 studies, 18 (72 %) reported retention strategies. We analyzed and coded retention strategies used in these studies and categorized strategies into intervention design, incentive, project bond, participant convenience, and participant tracking (Table 4). Retention strategies related to intervention design included culturally appropriate intervention activities and staff, developmentally appropriate goals for participants, a run-in phase before randomization, provision of counseling or technical support to help participants address participation barriers, regular interventionist–principal investigator meetings to ensure participant-centered intervention, and the use of a delayed or alternative intervention for control group. Incentives, such as grocery gift cards, gifts, cash, food, recipe books, and exercise equipment, were offered for intervention attendance or completion at each data collection point. Study staff also established project bonds with participants or the broader community by building staff–participant relationships, and regular communication with participants, such as thank-you notes, postcards, or project newsletters. Retention strategies related to participant convenience included transportation support to and from intervention activities or data collection, make-up sessions for missed intervention sessions, upcoming event reminders, childcare services, and optional days or home visits for data collection. To facilitate tracking participants, complete contact information was collected from participants at baseline and a tracking database established. One study mentioned sending personalized letters to participants who were difficult to reach, to schedule data collection appointments. Common retention methods used were alternative or delayed interventions for the control groups, monetary incentives, regular contact and relationship building with participants and the community, provision of transportation support, and offering flexible intervention and measurement visits.
Table 4

Retention strategies described in articles reviewed

Reference

Retention strategy

 

Retention rate

Intervention design

Incentive

Project bond

Participant convenience

Participant tracking

Davis et al. [15]

Run-in phase

Weekly grocery gift cards

Transportation support

79.4 % (54/68)

Ventura et al. [16]

Azevedo et al. [17]

Rewards for retention

100 % (252/252)

Berry et al. [1820]

1) Delayed intervention for control group

2) Counseling or support

1) Exercise equipment

2) Money for data collection

3) Food

4) Gifts

1) Regular contact

2) Refrigerator magnet

3) Building staff–participant relationship

1) Reminder message

2) Flexible data collection days

3) Childcare

4) Transportation support

1) Complete contact information

2) Toll-free line

3) Tracking letter

89.1 % (638/716)

Elizondo-Montemayor et al. [21]

Building staff–participant relationship

Reminder message

80.8 % (101/125)

Black et al. [24, 25]

Culturally sensitive

78.3 % (184/235)

Hurley et al. [26]

Witherspoon et al. [27]

Weigensberg et al. [28]

 

Transportation support Make-up session

82.9 % (29/35)

Ritchie et al. [33]

1) Alternative intervention for control group

2) Counseling or support

3) Culturally sensitive

1) Exercise equipment

2) Recipe books

1) Building staff–participant relationship

2) Regular contact

Transportation support

57.9 % (136/235)

Sharma et al. [34]

Burnet et al. [37]

1) Culturally sensitive

2) Activities at YMCA and grocery stores

Building staff–participant relationship

1) Convenient intervention sites

2) Transportation support

3) Child care

62.1 % (18/29)

Davis et al. [3840]

1) Weekly prizes

2) Increasing money for data collections

3) Food at intervention session

Regular contact

Transportation support

94.1 % (209/222)

Tkacz et al. [41]

Petty et al. [42]

Wickham et al. [44]

YMCA membership

Bean et al. [45]

1) YMCA membership

2) Grocery store gift card for data collection

Wysocki et al. [46, 47]

Alternative intervention for control group

1) Money for each data collection

2) Money for completing all intervention sessions

96.6 % (115/119)

Wysocki et al. [4850]

Alternative intervention for control group

1) Money for each data collection

2) Money for completion of all intervention sessions

88.5 % (92/104)

Ellis et al. [51, 52]

Alternative intervention for control group

Convenient intervention sites

92.9 % (118/127)

Story et al. [2]

1) Alternative intervention for control group

2) Fun intervention activities

3) Culturally sensitive

1) Gift for intervention attendance

2) Money

3) Increasing money for data collections

4) Additional money for blood draw

5) Food

1) Family nights

2) Regular contact

3) Build relationship between study and broader community

1) Convenient intervention sites

2) Flexible study procedures and measurement visits

3) Home visits for data collection

4) Transportation support

5) Childcare

6) Email and telephone reminders

1) Complete contact information

2) Tracking database

3) Calls from ‘non-identifiable’ cell phones

Phase I:

Rochon et al. [53]

Kumanyika et al. [54, 55]

91.4 % (32/35) and 100 % (60/60)

Klesges et al. [56, 57]

Phase II:

Robinson et al. [58, 59]

80.2 % (243/303) and 86.2 % (225/261)

Stockton et al. [60]

Natale et al. [61]

Alternative intervention for control group

Incentives (not specified)

Regular contact

Nansel et al. [62]

Alternative intervention for control group

1) Money for completing all data collections

2) Additional money for child providing blood glucose meter data

1) Appointment reminder calls

2) Follow-up calls after appointment

1) Transportation support

2) Midpoint evaluations by telephone

92.3 % (360/390)

Janicke et al. [63]

1) Delayed intervention for control group

2) Proper participant goals

3) Person-centered intervention

1) Drawing for gift card at weekly child session

2) Gift card per family for each session

3) Money for data collections

4) Food

1) Build community connections

2) Regular contact

3) Phone calls to participants after missed sessions

Make-up sessions

87.1 % (81/93)

Follansbee-Junger et al. [64]

Radcliff et al. [65]

Discussion

Summary of key findings

Our systematic review of recruitment and retention of minority or low-income children into obesity-related intervention trials identified 41 completed studies in the CTRD, two of which were linked to two studies. Of these 43 studies, only 25 (60 %) had published information on recruitment or retention in a peer-reviewed article, with considerable variation in the amount of information provided among studies. A further ≈ 10 % included no information about recruitment and retention in their papers. Even when we examined only the studies completed 2 years prior to the close date of our CTRD search, more than 30 % had no publications in peer-review journals. Although most studies with relevant information reported high retention rates, differences in retention rates existed by participant characteristics (i.e., race, obesity status, involving parents or caregivers) and study design (i.e., prevention or treatment, study duration, primary outcome, home-, community-, or school-based).

Previous studies that have examined recruitment and retention in this population

Two other studies have systematically examined published articles about recruitment and retention of children into obesity-related studies. Schoeppe et al. [3] summarized strategies used to recruit and retain children in behavioral health risk factor studies that achieved high capture rates and low attrition rates, while Amon et al. [8] systematically reviewed literature that included the use of Facebook to recruit 10–18-year-old children into studies that aimed to address physical or mental health issues. The authors found that paid advertising on Facebook was effective in recruiting these participants. These two studies used published literature only as their study frame; thus, their results did not cover studies without publications and could not evaluate the proportion of studies conducted with published information on recruitment and retention. Furthermore, these reviews focused on youth generally; thus, it is unclear whether findings can be generalized to minority or low-income children.

Qualitative and quantitative evidence in recruitment and retention

The articles identified in our review mainly provided narrative descriptions of recruitment and retention strategies used, investigators’ opinions on the effectiveness of these strategies, and lessons learned in individual studies. While this describes important qualitative study experiences related to recruitment and retention strategies, quantitative assessments of these strategies may also improve our understanding of their correlates and effects. Two prior observational studies have quantitatively examined factors associated with the success of recruitment and retention in intervention studies. Using discriminant function analysis and analysis of variance, Coatsworth et al. [9] found that retention patterns (i.e., non-attenders, variable attenders or consistently high attenders over intervention sessions) were associated with sociodemographic and child- and family-level characteristics in a family-based intervention aiming to prevent substance use in adolescent girls. Another study using chi-square analyses found that attrition of adolescent girls (the majority being African Americans) involved in a randomized controlled trial of a HIV-prevention intervention was associated with recruiters’ experiences, recruitment method, contact status, and parental awareness of study participation [10]. Our study is the first to examine retention rates quantitatively by participant characteristics and study design in obesity-related trials conducted in minority or low-income children and found results as expected.

In addition to retrospective analysis of the recruitment and retention efforts, prospective studies designed to test specific recruitment and retention strategies are needed. The randomized clinical trial design is considered to provide the strongest causal evidence. We identified three randomized trials that examined the effectiveness of direct mail letters containing different information in the recruitment of minority adults. For example, Brown et al. [11] randomly assigned 30,000 minority women into four groups formed by a factorial design: ethnically specific or generic statement on disease risk and personalized or non-personalized letterhead. They found that women who received letters with the ethnically specific statements were 34 % more likely to respond than women who received letters with a generic statement, while there was no significant difference in response between women who received personalized letters and those who received non-personalized letters. However, we did not identify any randomized controlled trials that examined the effect of recruitment and retention strategies in minority or low-income children. Considering the limited amount of quantitative evidence available, further analytical study is needed to examine the success rates of recruitment and retention strategies in a broader scope.

Limited publications available

We found that one-third of eligible studies had not published a peer-reviewed paper. This proportion remained true if we allowed for additional time for manuscripts to reach the publication stage by excluding studies that were completed less than 2 years before our search of the CTRD. Ross et al. [12] examined 635 clinical trials funded by the National Institutes of Health and registered within CTRD and found that more than half of the trials did not publish an article in a peer-reviewed journal indexed by Medline within 2.5 years of trial completion. Furthermore, after 51 months of trial completion, a third of trials remained unpublished. Multiple factors might have contributed to this high non-publication rate, including those beyond the control of the investigators [12, 13]. Ross et al. [12] also suggested that 12–24 months should be the goal for results from clinical trials to be published. Furthermore, among studies with published peer-reviewed papers, the scope and amount of information reported varied. The non-publication of studies and inconsistent report of recruitment and retention hinders the sharing of experiences and lessons learned, as well as limiting the synthesis of data across studies. Reporting guidelines, including STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) and Consolidated Standards of Reporting Trials (CONSORT), have improved the reporting of observational and experimental studies in journals that support these guidelines. The development of guidelines for reporting recruitment and retention would be a first step in improving the quality of information reported in this area.

Strengths and limitations

An advantage of our study is that we used the CTRD as the study frame and focused specifically on minority or low-income participants. In addition, the studies included varied substantially in terms of participants’ characteristics and study design, which allowed us to describe recruitment and retention strategies more broadly and to examine the retention rates quantitatively by study characteristics. Our study has limitations. We searched only one trial registry. However, most obesity-related trials conducted in the United States after the launch of the CTRD might have been registered in this database. In addition, the limited number of studies identified in our study hampered our ability to conduct multivariate analysis, to examine factors associated with retention rates.

Conclusions

In conclusion, although studies with a published, peer-reviewed article generally achieved high retention rates, limited information on recruitment and retention strategies was available. There is a need for more consistent reporting and systematic cataloging of recruitment and retention methods. Both qualitative and quantitative evidence are warranted to inform evidence-based decisions in choosing effective recruitment and retention strategies for trials involving minority or low-income children.

Abbreviations

BMI: 

body mass index

CONSORT: 

Consolidated Standards of Reporting Trials

CTRD: 

Clinical Trials Registration Database

GEMS: 

Girls Health Enrichment Multi-Site Studies

STROBE: 

STrengthening the Reporting of OBservational studies in Epidemiology

Declarations

Acknowledgements

This research was supported by grants U01 HL103561, U01 HL103620, U01 HL103622, U01 HL103629, and U01 HD068890 from the National Heart, Lung, and Blood Institute and the Eunice Kennedy Shriver National Institute of Child Health and Development and the Office of Behavioral and Social Sciences Research. This work was also supported by the National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health (grant numbers R21DK078239, P30DK050456, P30DK092924). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the National Institute of Child Health and Development.

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

Authors’ Affiliations

(1)
Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill
(2)
HealthPartners Institute for Education and Research

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