The recruitment experience of a randomized clinical trial to aid young adult smokers to stop smoking without weight gain with interactive technology

AbstractMultiple recruitment strategies are often needed to recruit an adequate number of participants, especially hard to reach groups. Technology-based recruitment methods hold promise as a more robust form of reaching and enrolling historically hard to reach young adults. The TARGIT study is a randomized two-arm clinical trial in young adults using interactive technology testing an efficacious proactive telephone Quitline versus the Quitline plus a behavioral weight management intervention focusing on smoking cessation and weight change. All randomized participants in the TARGIT study were required to be a young adult smoker (18–35 years), who reported smoking at least 10 cigarettes per day, had a BMI < 40 kg/m2, and were willing to stop smoking and not gain weight. Traditional recruitment methods were compared to technology-based strategies using standard descriptive statistics based on counts and proportions to describe the recruitment process from initial pre-screening (PS) to randomization into TARGIT. Participants at PS were majority Black (59.80%), female (52.66%), normal or over weight (combined 62.42%), 29.5 years old, and smoked 18.4 cigarettes per day. There were differences in men and women with respect to reasons for ineligibility during PS (p < 0.001; ignoring gender specific pregnancy-related ineligibility). TARGIT experienced a disproportionate loss of minorities during recruitment as well as a prolonged recruitment period due to either study ineligibility or not completing screening activities. Recruitment into longer term behavioral change intervention trials can be challenging and multiple methods are often required to recruit hard to reach groups.ClinicalTrials.gov Identifier NCT01199185The NHLBI funded TARGIT as part of a U01 Cooperative Agreement and as such the study design was approved. They did not have input into the data collection, analysis, or the interpretation of the data or in the writing of this report

Social Isolation and Incident Heart Failure Hospitalization in Older Women: Women\u27s Health Initiative Study Findings

Background The association of social isolation or lack of social network ties in older adults is unknown. This knowledge gap is important since the risk of heart failure (HF) and social isolation increase with age. The study examines whether social isolation is associated with incident HF in older women, and examines depressive symptoms as a potential mediator and age and race and ethnicity as effect modifiers. Methods and Results This study included 44 174 postmenopausal women of diverse race and ethnicity from the WHI (Women\u27s Health Initiative) study who underwent annual assessment for HF adjudication from baseline enrollment (1993-1998) through 2018. We conducted a mediation analysis to examine depressive symptoms as a potential mediator and further examined effect modification by age and race and ethnicity. Incident HF requiring hospitalization was the main outcome. Social isolation was a composite variable based on marital/partner status, religious ties, and community ties. Depressive symptoms were assessed using CES-D (Center for Epidemiology Studies-Depression). Over a median follow-up of 15.0 years, we analyzed data from 36 457 women, and 2364 (6.5%) incident HF cases occurred; 2510 (6.9%) participants were socially isolated. In multivariable analyses adjusted for sociodemographic, behavioral, clinical, and general health/functioning; socially isolated women had a higher risk of incident HF than nonisolated women (HR, 1.23; 95% CI, 1.08-1.41). Adding depressive symptoms in the model did not change this association (HR, 1.22; 95% CI, 1.07-1.40). Neither race and ethnicity nor age moderated the association between social isolation and incident HF. Conclusions Socially isolated older women are at increased risk for developing HF, independent of traditional HF risk factors. Registration URL: http://www.clinicaltrials.gov; Unique identifier: NCT00000611

Social isolation and incident heart failure hospitalization in older women: Women\u27s health initiative study findings

Background The association of social isolation or lack of social network ties in older adults is unknown. This knowledge gap is important since the risk of heart failure (HF) and social isolation increase with age. The study examines whether social isolation is associated with incident HF in older women, and examines depressive symptoms as a potential mediator and age and race and ethnicity as effect modifiers. Methods and Results This study included 44 174 postmenopausal women of diverse race and ethnicity from the WHI (Women\u27s Health Initiative) study who underwent annual assessment for HF adjudication from baseline enrollment (1993-1998) through 2018. We conducted a mediation analysis to examine depressive symptoms as a potential mediator and further examined effect modification by age and race and ethnicity. Incident HF requiring hospitalization was the main outcome. Social isolation was a composite variable based on marital/partner status, religious ties, and community ties. Depressive symptoms were assessed using CES-D (Center for Epidemiology Studies-Depression). Over a median follow-up of 15.0 years, we analyzed data from 36 457 women, and 2364 (6.5%) incident HF cases occurred; 2510 (6.9%) participants were socially isolated. In multivariable analyses adjusted for sociodemographic, behavioral, clinical, and general health/functioning; socially isolated women had a higher risk of incident HF than nonisolated women (HR, 1.23; 95% CI, 1.08-1.41). Adding depressive symptoms in the model did not change this association (HR, 1.22; 95% CI, 1.07-1.40). Neither race and ethnicity nor age moderated the association between social isolation and incident HF. Conclusions Socially isolated older women are at increased risk for developing HF, independent of traditional HF risk factors. Registration URL: http://www.clinicaltrials.gov; Unique identifier: NCT00000611

Methods and baseline characteristics of a randomized trial treating early childhood obesity: The Positive Lifestyles for Active Youngsters (Team PLAY) trial

There are few effective obesity interventions directed towards younger children, particularly young minority children. This paper describes the design, intervention, recruitment methods, and baseline data of the ongoing Positive Lifestyles for Active Youngsters (Team PLAY) study. This randomized controlled trial is designed to test the efficacy of a 6-month, moderately intense, primary care feasible, family-based behavioral intervention, targeting both young children and their parent, in promoting healthy weight change. Participants are 270 overweight and obese children (ages 4 to 7 years) and their parent, who were recruited from a primarily African American urban population. Parents and children were instructed in proven cognitive behavioral techniques (e.g. goal setting, self-talk, stimulus control and reinforcement) designed to encourage healthier food choices (more whole grains, fruits and vegetables, and less concentrated fats and sugar), reduce portion sizes, decrease sweetened beverages and increase moderate to vigorous physical activity engagement. The main outcome of this study is change in BMI at two years post enrollment. Recruitment using reactive methods (mailings, TV ads, pamphlets) was found to be more successful than using only a proactive approach (referral through physicians). At baseline, most children were very obese with an average BMI z-score of 2.6. Reported intake of fruits and vegetables and minutes of moderate to vigorous physical activity engagement did not meet national recommendations. If efficacious, Team PLAY would offer a model for obesity treatment directed at families with young children that could be tested and translated to both community and primary care settings

Body Esteem, Peer Difficulties, and Perceptions of Physical Health in Overweight and Obese Urban Children Ages 5 to 7 Years

Objective—To determine whether there is an association between body mass index (BMI) and body esteem in young overweight and obese urban children, and to test peer relationship difficulties and perceived physical health as mediators of this relationship. Methods—Child self-reported body esteem, and parent-reported child peer relationship difficulties (being bullied by peers and peer rejection) and physical health perceptions were obtained from 218 overweight and obese children ages 5–7 years (81% racial/ethnic minority, M BMI = 25.3) and their primary caregivers. Results—Higher BMI was associated with lower body esteem for both girls and boys. This relation was mediated by poor physical health for boys but not for girls. Peer relationship difficulties did not mediate the observed association between BMI and body esteem in either group; however, girls with higher BMI experienced more bullying and being bullied by peers was associated with lower body esteem in girls. Conclusions—Intervening with perceptions of physical health may buffer overweight and obese boys from developing low body esteem in early childhood

Screening, safety, and adverse events in physical activity interventions: Collaborative experiences from the behavior change consortium

Researchers who conduct physical activity (PA) intervention studies provide an invaluable opportunity to further the prevention science knowledge base for implementing and delivering PA programs. Despite recommendations that screening is important to increase patient safety, the specific screening criteria best suited for different community applications are unknown. To add to the limited knowledge base, we examined the screening procedures and the occurrence of adverse events among more than 5,500 participants from 11 diverse PA interventions participating in a trans-National Institutes of Health (NIH) collaborative known as the Behavior Change Consortium (BCC). Numerous adverse events occur in sedentary, chronically ill, or older populations, although few are attributed to activity/exercise interventions. No serious study-related adverse events (SRAEs) were reported across different screening practices, interventions, and/or populations. Relatively few minor SRAEs were reported (primarily musculoskeletal injuries), emphasizing the need to be aware of potential musculoskeletal sequelae during exercise interventions. One common characteristic of these studies is that they recommended start low and go slow strategies, with moderate intensity PA as the goal behavior. Recommendations to reframe the meaning and use of screening criteria to initiate PA in the community are discussed. Although we were unable to conduct generalizable quantitative analyses from our data, the combined experience of the BCC studies provides a unique opportunity to examine PA-related screening and safety issues across diverse populations, settings, and intervention programs. © 2005 by The Society of Behavioral Medicine

Strategies for retaining study participants in behavioral intervention trials: Retention experiences of the NIH behavior change consortium

Failing to retain an adequate number of study participants in behavioral intervention trials poses a threat to interpretation of study results and its external validity. This qualitative investigation describes the retention strategies promoted by the recruitment and retention committee of the Behavior Change Consortium, a group of 15 university-based sites funded by the National Institutes of Health to implement studies targeted toward disease prevention through behavior change. During biannual meetings, focus groups were conducted with all sites to determine barriers encountered in retaining study participants and strategies employed to address these barriers. All of the retention strategies reported were combined into 8 thematic retention categories. Those categories perceived to be most effective for retaining study participants were summarized and consistencies noted among site populations across the life course (e.g., older adults, adults, children, and adolescents). Further, possible discrepancies between site populations of varying health statuses are discussed, and an ecological framework is proposed for use in future investigations on retention. © 2005 by The Society of Behavioral Medicine