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

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

Risk Factors for Poor Attendance in a Family-based Pediatric Obesity Intervention Program for Young Children

Objective—This study examined the role of demographic characteristics, psychological factors, and family functioning on attendance in a randomized controlled trial of a family-based pediatric obesity program. Method—Participants included 155 children between the ages of 4 and 7 years (M age = 5.77, 57.4% female, 73.6% African-American, M BMI = 25.5) and their primary caregivers who were randomized to the treatment group. Three groups of participants were created based on their patterns of attendance during the program: 1) noncompleters, 2) partial completers, and 3) completers. Results—Results indicated no differences among the attendance groups in child gender, child BMI, or child psychological functioning. Significant group differences were found with respect to race/ethnicity, parent marital status, and family income, such that noncompleters were more likely to be racial/ethnic minorities, to living in single parent households, and to have lower incomes than partial completers and completers. After controlling for the effects these socio-demographic risk factors, noncompleters and partial completers reported more family dysfunction characterized by high levels of disengagement than completers. Conclusion—Adapting existing weight management programs to include a focus on family engagement in the early stages of treatment may help to improve participation in family-based obesity interventions targeting high risk, socio-economically disadvantaged youth

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

Get fit with the Grizzlies: A community-school-home initiative to fight childhood obesity led by a professional sports organization

Background: Professional sports organizations in the United States have notable celebrity status, and several teams have used this star power to collaborate with local schools toward the goal of affecting childhood obesity (e.g., NFL Play 60). Program effectiveness is unknown owing to the absence of comprehensive evaluations for any of these initiatives. In 2006, the Memphis Grizzlies, the city\u27s National Basketball Association (NBA) franchise, launched Get Fit with the Grizzlies, a 6-week, curricular addition focusing on nutrition and physical activity for the 4th and 5th grades in Memphis City Schools. The health-infused mini-unit was delivered by the physical education teachers during their classes. National and local sponsors whose business objectives matched the Get Fit objectives were solicited to fund the program. Here we highlight the program evaluation results from the first year of Get Fit and the Journal of School Health article. However, the Get Fit program has now taken place in Memphis area schools for 5 years. During the 2010-11 school-year, Get Fit evolved into a new program called Healthy Home Court with Kellogg\u27s as the primary sponsor. Healthy Home Court included the original fitness part of the program and added a breakfast component at high schools where data indicated great need. Kellogg\u27s sponsored special carts with healthy breakfast options (i.e., fruit, protein bars) for students to grab and eat. This program matched their existing program Food Away from Home. Research supports the objectives of these programs and has shown that breakfast consumption can have a positive impact on academic achievement, behavior in school, and overall health status. Method: Survey research employed over the first 4 years measured health knowledge acquisition and health behavior change using a matched pre/post test design (n=2210) in randomly chosen schools (n=18) from all elementary schools in the Memphis area. McNemar\u27s test for significance (p\u3c.05) was applied to measure correct answers pre and post. Also, breakfast attendance numbers were observed for intervention high schools and compared with breakfast attendance numbers from control high schools. Results: Analyses confirmed that, from the first year through this past one (2010-11), there was significant health knowledge acquisition and health behavior improvement at post-intervention. Breakfast numbers matched these findings. Also, exit polling that took place at one intervention high school indicated the students attending the breakfast assembly gained knowledge and positively changed attitudes regarding the academic and health benefits of eating a healthy breakfast. Conclusions: This community-school-home initiative using a professional team\u27s celebrity platform is largely overlooked by school districts and should be considered as an effective way to confront childhood obesity. © 2012 The authors and IOS Press. All rights reserved

Get fit with the grizzlies: A community-school-home initiative to fight childhood obesity

Background: Professional sport organizations in the United States have notable celebrity status, and several teams have used this star power to collaborate with local school districts toward the goal of affecting children\u27s health. Program effectiveness is unknown due to the absence of comprehensive evaluations for these initiatives. The Memphis Grizzlies, the city\u27s National Basketball Association franchise, launched Get Fit with the Grizzlies, a 6-week, curricular addition focusing on nutrition and physical activity for the fourth and fifth grades in Memphis City Schools (MCS). The health-infused mini-unit was delivered by physical education teachers during their classes. The purpose of this study was to evaluate the Get Fit program effectiveness.Methods: Survey research was employed which measured health knowledge acquisition and health behavior change using a matched pre/posttest design in randomly chosen schools (n = 11) from all elementary schools in the MCS system (N = 110). The total number of matched pre/posttests (n = 888) equaled approximately 5% of the total fourth-/fifth-grade population. McNemar\u27s test for significance (p \u3c .05) was applied. Odds ratios were calculated for each question.Results: Analyses confirmed that there was significant health knowledge acquisition (7 of 8 questions) with odds ratios confirming moderate to strong associations. Seven out of 10 health behavior change questions significantly improved after intervention, whereas odds ratios indicated a low level of association after intervention.Conclusions: This community-school-home initiative using a professional team\u27s celebrity platform within a certain locale is largely overlooked by school districts and should be considered as a positive strategy to confront childhood obesity. © 2010, American School Health Association

Physical activity and risk of benign proliferative epithelial disorders of the breast, in the Women's Health Initiative

Background: Recreational physical activity (PA) has been shown to be inversely associated with breast cancer risk. However, the association of recreational PA with benign proliferative epithelial disorders (BPED) of the breast, conditions associated with increased risk of breast cancer, has not been adequately studied. Methods: We used data from an ancillary study of benign breast disease conducted among the 68 132 postmenopausal women (aged 50-79 at recruitment) participating in the Women's Health Initiative randomized clinical trials. All clinical trial participants underwent annual or biennial mammogram screening. During the follow-up, for women who reported breast biopsies but were cancer free, the associated histological sections were obtained and subjected to standardized central pathology review. Self-reported recreational PA at baseline (n = 61 684) and at 3 years of the follow-up (n = 55 923) were quantified as metabolic equivalents [MET]-h/week. There were 1624 confirmed BPED cases during an average follow-up time of 7.7 years. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs). Results: Higher average PA over 4 years was associated with lower risk of non-atypical BPED (P-trend = 0.02). There was a 6% lower risk of non-atypical BPED for every 5 MET-h/week increase between baseline and year 3 (HR = 0.94, 95% CI 0.89-0.99). Compared with women who remained inactive (PAbaseline and PAyear3 <9 MET-h/week), those who became active (PAbaseline<9 MET-h/week to PAyear3 ≥9 MET-h/weekee), remained active (PAbaseline and PAyear3 ≥9 MET-h/week), or decreased activity (PAbaseline ≥9 MET-h/week to PAyear3 <9 MET-h/week) had lower BPED risk. Conclusions: Recreational physical activity after menopause was associated with lower BPED risk among postmenopausal women

Community-based physical activity as adjunctive smoking cessation treatment: Rationale, design, and baseline data for the Lifestyle Enhancement Program (LEAP) randomized controlled trial

Despite advances in behavioral and pharmacological treatment for tobacco use and dependence, quit rates remain suboptimal. Increasing physical activity has shown some promise as a strategy for improving cessation outcomes. However, initial efficacy studies focused on intensive, highly structured exercise programs that may not be applicable to the general population of smokers. We describe the rationale and study design and report baseline participant characteristics from the Lifestyle Enhancement Program (LEAP), a two-group, randomized controlled trial. Adult smokers who engaged in low levels of leisure time physical activity were randomly assigned to treatment conditions consisting of an individualized physical activity intervention delivered by health fitness instructors in community-based exercise facilities or an equal contact wellness control. All participants received standard cognitive behavioral smoking cessation counseling combined with nicotine replacement therapy. The primary outcomes are seven-day point prevalence abstinence at seven weeks, six- and 12 months. Secondary outcomes include self-reported physical activity, dietary intake, body mass index, waist circumference, percent body fat, and nicotine withdrawal symptoms. Participants consist of 392 sedentary smokers (mean [standard deviation] age = 44.6 [10.2] = years; 62% female; 31% African American). Results reported here provide information regarding experiences recruiting smokers willing to change multiple health behaviors including smoking and physical activity

Recreational physical activity, sitting, and androgen metabolism among postmenopausal women in the Women's Health Initiative Observational Study

BackgroundProlonged sitting and physical inactivity are associated with higher circulating levels of estrogens. It is unknown whether these risk factors are associated with circulating androgens/androgen metabolites, another set of hormones implicated in the etiology of cancers in postmenopausal women.MethodsWe conducted a cross-sectional analysis of 1,782 postmenopausal women in the Women's Health Initiative Observational Study. Serum concentrations of 12 androgens/androgen metabolites were quantified using liquid chromatography-tandem mass spectrometry. Physical activity and sitting time were self-reported at baseline. We performed linear regression to estimate geometric means (GM) of androgen/androgen metabolite concentrations (pmol/L) according to physical activity and sitting time, adjusting for potential confounders and stratified by menopausal hormone therapy (MHT) use.ResultsPhysical activity (≥15 vs. 0 MET-h/wk) was inversely associated with estrogen-to-androgen ratios among never/former MHT users (adj-GM = 37.5 vs. 49.6 unconjugated estrone:androstenedione; 20.2 vs. 30.3 unconjugated estradiol:testosterone; all P trend ≤ 0.03) but was not associated among current MHT users. Prolonged sitting (≥10 vs. ≤5 h/d) was positively associated with these ratios among both never/former (adj-GM = 44.2 vs. 38.3, P trend = 0.10; adj-GM = 23.4 vs. 20.2, P trend = 0.17; respectively) and current MHT users (adj-GM = 197 vs. 147; 105 vs. 75.5; respectively; all P trend ≤0.02), but the associations were statistically significant among current MHT users only. The associations persisted after adjustment for BMI. After adjustment for adrenal androgens, physical activity and sitting were not associated with androgen metabolites.ConclusionsPhysical activity and sitting were associated with serum estrogen-to-androgen ratios but not androgen metabolites.ImpactThis study contributes to our understanding of the link between physical activity, sitting, and cancer risk in postmenopausal women