Recruiting young adults into a weight loss trial: report of protocol development and recruitment results.
Ontology highlight
ABSTRACT:
SUBMITTER: Corsino L
PROVIDER: S-EPMC3765064 | biostudies-literature | 2013 Jul
REPOSITORIES: biostudies-literature
Publications
Recruiting young adults into a weight loss trial: report of protocol development and recruitment results.
Corsino Leonor L Lin Pao-Hwa PH Batch Bryan C BC Intille Stephen S Grambow Steven C SC Bosworth Hayden B HB Bennett Gary G GG Tyson Crystal C Svetkey Laura P LP Voils Corrine I CI
Contemporary clinical trials 20130413 2
Obesity has spread to all segments of the U.S. population. Young adults, aged 18-35 years, are rarely represented in clinical weight loss trials. We conducted a qualitative study to identify factors that may facilitate recruitment of young adults into a weight loss intervention trial. Participants were 33 adults aged 18-35 years with BMI ≥25 kg/m(2). Six group discussions were conducted using the nominal group technique. Health, social image, and "self" factors such as emotions, self-esteem, and ...[more]
Similar Datasets
Project description:Young adulthood (age 18 to 35) is a high-risk period for unhealthy weight gain. Few studies have recruited for prevention of weight gain, particularly in young adults. This paper describes the recruitment protocol used in the Study of Novel Approaches to Prevention (SNAP).We conducted extensive formative work to inform recruitment methods and message development. We worked with a professional marketing firm to synthesize major themes and subsequently develop age-appropriate messages for recruitment. A variety of approaches and channels were used across two clinical centers to recruit young adults who were normal or overweight (body mass index (BMI) 21 to 30 kg/m2) for a 3-year intervention designed to prevent weight gain. We tracked recruitment methods, yields, and costs by method. Logistic regression was used to identify recruitment methods that had the highest relative yield for subgroups of interest with covariate adjustments for clinic.The final sample of 599 participants (27% minority, 22% male) was recruited over a 19-month period of sustained efforts. About 10% of those who initially expressed interest via a screening website were randomized. The most common reason for ineligibility was already being obese (BMI >30 kg/m2). The top two methods for recruitment were mass mailing followed by email; together they were cited by 62% of those recruited. Television, radio, paid print advertising, flyers and community events each yielded fewer than 10% of study participants. Email was the most cost-effective method per study participant recruited.These findings can guide future efforts to recruit young adults and for trials targeting weight gain prevention.ClinicalTrials.gov NCT01183689 (registered 13 August 2010).
| S-EPMC4150977 | biostudies-literature
Project description:Young adults are at risk of weight gain, but little is known about designing effective weight control trials for young adults or how to recruit and retain participants in these programs. The Choosing Healthy Options in College Environments and Settings (CHOICES) study evaluated the effectiveness of a weight gain prevention intervention for 2-year college students. We describe the methods used to recruit and retain the colleges and their students, describe the sample and discuss recommendations for future studies.Students were recruited into a 24-month trial of a weight control intervention with assessment periods at baseline, 4-, 12- and 24-month follow-up.We successfully recruited 441 students through partnerships with three 2-year colleges through a variety of campus-based methods. Ultimately, 83.4% of the randomized cohort participated in the 24-month assessment period. Those retained more often were White (p?=?0.03) compared to those who dropped out or were lost to follow-up; no other socio-demographic factor (e.g. gender, ethnicity and education), body mass index, body fat, waist circumference or weight status was observed to differ between randomly assigned groups.Two-year colleges and their students are interested in participating in weight-related trials and partnering with universities for research. Researchers must work closely with administrators to identify benefits to their institutions and to resolve student-level barriers to recruitment and retention. Our experiences from the Choosing Healthy Options in College Environments and Settings study should be useful in identifying effective recruitment and retention methods for weight gain prevention trials among young adults.
| S-EPMC4785077 | biostudies-literature
Project description:BackgroundRecruiting young adults (ages 18-35 years) into weight gain prevention intervention studies is challenging and men are particularly difficult to reach. This paper describes two studies designed to improve recruitment for a randomized trial of weight gain prevention interventions. Study 1 used a quasi-experimental design to test the effect of two types of direct mailings on their overall reach. Study 2 used a randomized design to test the effect of using targeted messages to increase recruitment of men into the trial.MethodsFor Study 1, 60,000 male and female young-adult households were randomly assigned to receive either a recruitment brochure or postcard. Visits to recruitment websites during each mailing period were used to assess response to each mailing. Study 2 focused on postcard recruitment only. These households received either a targeted or generic recruitment postcard, where targeted postcards included the word "Men" in the headline text. Response rates to each type of card were categorized based on participant report of mailing received.ResultsThe reach of the postcards and brochures were similar (421 and 386 website visits, respectively; P = 0.22). Individuals who received the brochure were more likely to initiate the online screener than those who received a postcard (P = 0.01). In Study 2, of those who completed the telephone screening, 60.9 % of men (n = 23) had received the targeted postcard as compared to the generic postcard (39.1 %, P = 0.30). The reverse was true for women (n = 62, 38.7 vs. 61.3 %, P = 0.08).ConclusionsThese studies suggest there was little difference in the reach of postcards versus brochures. However, recipients of brochures were more likely to continue to the next stage of study participation. As expected, men's response to the weight gain prevention messages was lower than women's response; but using targeted messages appears to have modestly increased the proportion of male respondents. These studies add to the limited experimental literature on recruitment messaging and provide further indication for using targeted messages to reach underrepresented populations while providing initial evidence on the effect of mailing type on message reach.Trial registrationThe Study of Novel Approaches to Weight Gain Prevention was registered with ClinicalTrials.gov (identifier: NCT01183689 ) on 13 August 2010.
| S-EPMC4897900 | biostudies-literature
Project description:Recruiting young adults into weight loss interventions poses challenges that may be mitigated by the use of novel social marketing strategies. The purpose of this study is to describe how social marketing principles were applied to recruitment for a digitally delivered randomized controlled trial for weight management among young adults and report recruitment data and demographics on those who enrolled and did not enroll in the study. The marketing mix of the 7Ps (i.e., product, price, place, promotion, packaging, positioning, and people) was applied to intervention recruitment. Prior to enrollment, respondents completed a screening survey, which was examined to determine optimal strategies for study awareness and enrollment. Of the initial 5,731 who initiated a screener, 3,059 provided data on the source of where they heard about the study. Subsequently, 460 (12.5%) were enrolled in the study, 409 (51.3% non-White; 78.7% female; body mass index: 30.6 ± 4.3) provided data on recruitment source, with emails (72.5%), cited most often followed by flyers/posters (8.8%), "other" (6.7%), and multiple sources (6.6%). Although email remained the most frequently cited promotion source, Pearson's chi-squared tests revealed that, compared to those not enrolled in the study, those who enrolled were more likely to hear about the study via flyers/posters (enrolled = 14.4%; not enrolled = 7.9%; p < .001) and multiple sources (enrolled = 11.7%; not enrolled 5.85%; p < .01) and less likely to hear via email (enrolled = 62.1%; not enrolled = 74.2%; p < .01). This study applied social marketing principles to successfully recruit a large and diverse group of young adults. While email emerged as the most effective source of study awareness, multiple channels and a mix of marketing principles are recommended for recruiting in university settings.
| S-EPMC7963283 | biostudies-literature
Project description:Christakis and colleagues have shown that health behaviors cluster in social networks and suggest social norms may account for the clustering. This study examined: (i) whether obesity clusters among young adults and whether social norms do in fact account for the clustering, and (ii) among overweight/obese (OW/OB) young adults, whether number of social contacts trying to lose weight is associated with weight loss intentions and whether social norms for weight loss account for this effect. Normal weight (NW) and OW/OB young adults (N = 288; 66% female; 75% white) completed measures assessing number of OW social contacts and social norms for obesity. OW/OB young adults also indicated number of OW social contacts currently trying to lose weight, social norms for weight loss, and weight loss intentions. Compared to NW, OW/OB young adults were more likely to have OW romantic partners and best friends and had more OW casual friends and family members (Ps < 0.05), but social norms for obesity did not differ between groups, and social norms did not mediate the relationship between OW social contacts and participants' weight status. However, among OW/OB young adults, having more social contacts trying to lose weight was associated with greater intention to lose weight (r = 0.20, P = 0.02) and social norms for weight loss fully mediated this effect (P < 0.01). This study is the first to show that social contacts and normative beliefs influence weight status and intentions for weight control in young adults. Findings underscore the importance of targeting social influence in the treatment and prevention of obesity in this high-risk age group.
| S-EPMC3079776 | biostudies-literature
Project description:ObjectiveTo assess whether parent training in behavioral intervention, combined with a 16-session nutrition and activity education program, would improve weight loss relative to nutrition and activity education alone in adolescents and young adults with Down syndrome.Study designTwenty-one patients with Down syndrome aged 13-26 years with a body mass index ? 85 th percentile were enrolled and randomized to a 6-month nutrition and activity education intervention (n = 10) or to a nutrition and activity education+behaviorial intervention (n = 11), and followed for 6 months after the active intervention period (1-year follow-up). The primary outcome measure was body weight; secondary outcomes included percentage body fat by bioelectric impedance; intake of fruits, vegetables, and energy-dense low-nutrient snack food (treats) by 3-day food record; and moderate/vigorous physical activity by accelerometry.ResultsAt 6 months, mean body weight in the nutrition and activity education+behavioral intervention group was 3.2 kg lower than that in the nutrition and activity education group (95% CI, 1.0-5.5 kg; P = .005). Mean group differences were sustained at 1 year (3.6 kg; 95% CI, 1.4-5.9 kg; P = .002). At 6 months, moderate/vigorous physical activity time increased by an average of 18 minutes/day compared with baseline in the nutrition and activity education+behavioral intervention group (P = .01) and decreased by 7 minutes/day in the nutrition and activity education group (P = .30). These changes were largely maintained at 1 year, but were not statistically significant. Vegetable intake in the nutrition and activity education+behavioral intervention group exceeded that in the nutrition and activity education group by a mean of 1.6 servings at 1 year (P = .009), but not at 6 months. No between-group differences were observed for percentage body fat or consumption of fruits or treats.ConclusionParent-supported behavioral intervention appears to be a successful adjunct to a 6-month nutrition education intervention in achieving weight loss in adolescents and young adults with Down syndrome.
| S-EPMC3812279 | biostudies-literature
Project description:African-American women are disproportionately affected by obesity. Weight loss can occur, but maintenance is rare. Little is known about weight loss maintenance in African-American women.(1) To increase understanding of weight loss maintenance in African-American women; (2) to use the elicitation procedure from the theory of planned behavior (TPB) to define the constructs of attitude, subjective norms, and perceived behavioral control regarding weight loss and maintenance; and (3) to help develop a relevant questionnaire that can be used to explore weight loss and maintenance in a large sample of African Americans.Seven focus groups were conducted with African-American women: four with women successful at weight loss maintenance, three with women who lost weight but regained it. Discussions centered on weight loss and maintenance experiences.Thirty-seven African-American women.Content analysis of focus group transcripts.Weight loss maintainers lost 22% of body weight. They view positive support from others and active opposition to cultural norms as critical for maintenance. They struggle with weight regain, but have strategies in place to lose weight again. Some maintainers struggle with being perceived as sick or too thin at their new weight. Regainers and maintainers struggle with hairstyle management during exercise. The theoretical constructs from TPB were defined and supported by focus group content.A weight loss questionnaire for African Americans should include questions regarding social support in weight maintenance, the importance of hair management during exercise, the influence of cultural norms on weight and food consumption, and concerns about being perceived as too thin or sick when weight is lost.
| S-EPMC2219715 | biostudies-other
Project description:BackgroundDespite the reported benefits, weight loss is not always advised for older adults because some observational studies have associated weight loss with increased mortality. However, the distinction between intentional and unintentional weight loss is difficult to make in an observational context, so the effect of intentional weight loss on mortality may be clarified in the setting of a randomized controlled trial.ObjectiveThe objective was to determine the effect of intentional weight loss on all-cause mortality by using follow-up data from a randomized trial completed in 1995 that included a weight-loss arm.DesignThe Trial of Nonpharmacologic Intervention in the Elderly (TONE) used a 2 × 2 factorial design to determine the effect of dietary weight loss, sodium restriction, or both on blood pressure control in 585 overweight or obese older adults being treated for hypertension (mean ± SD age: 66 ± 4 y; 53% female). All-cause mortality was ascertained by using the Social Security Index and National Death Index through 2006.ResultsThe mortality rate of those who were randomly assigned to the weight-loss intervention (n = 291; mean weight loss: 4.4 kg) did not differ significantly from that of those who were not randomly assigned to this group (n = 294; mean weight loss: 0.8 kg). The adjusted HR was 0.82 (95% CI: 0.55, 1.22).ConclusionsIntentional dietary weight loss was not significantly associated with increased all-cause mortality over 12 y of follow-up in older overweight or obese adults. Additional studies are needed to confirm and extend our findings to older age groups. This trial is registered at clinicaltrials.gov as NCT00000535.
| S-EPMC3155925 | biostudies-literature
Project description:BackgroundObesity and its related illnesses are a major health problem around the world. Saudi Arabia has one of the highest national obesity rates globally; however, it is not easy to intervene to prevent obesity and becoming overweight owing to Saudi Arabia's cultural and social norms, and linguistic barriers. In recent years, there has been an exponential growth in the usage of smartphones and apps in Saudi Arabia. These could be used as a cost-effective tool to facilitate the delivery of behavior-modification interventions for obese and overweight people. There are a variety of health and fitness apps that claim to offer lifestyle-modification tools. However, these do not identify the motivational features required to overcome obesity, consider the evidence-based practices for weight management, or enhance the usability of apps by considering usability attributes.ObjectiveThis study aimed to explore the opportunity and the need to develop an Arabic weight-loss app that provides localized content and addresses the issues with existing apps identified here. This study has explained the steps taken to design an Arabic weight-loss app that was developed to facilitate the adjustment of key nutritional and physical activities and behaviors, which considers the social and cultural norms of Saudi Arabia.MethodsQualitative studies were conducted with 26 obese Saudi Arabians, who tested the level of usability of 2 weight-loss apps and then provided feedback and recommendations. The app Akser Waznk is an interactive, user-friendly app designed primarily for iPhones. It has several features intended to assist users to monitor and track their food consumption and physical activities. The app provides personalized diet and weight loss advice. Unique features such as Let's Walk are designed to motivate users to walk more. An augmented reality function is implemented to provide information regarding fitness equipment, fruits, and vegetables. The app uses behavior-change techniques to increase activities and healthy behaviors and evidence-informed practices for weight-loss management. The Akser Waznk app considers user privacy and data security by applying a number of guidelines and procedures.ResultsThe development of the app took 26 months. In all, 7 experts (5 dietitians, and 2 physical activity professionals) evaluated the app's contents. Moreover, 10 potential users (5 men and 5 women) tested the app's level of usability, its features, and performance during a pilot study. They reported that the app's design is interactive, and the motivational features are user-friendly.ConclusionsMobile technology, such as mobile apps, has the potential to be an effective tool that facilitates the changing of unhealthy lifestyle behaviors within the Saudi community. To be successful, the target group, the usability, motivational features, and social and cultural norms must be considered.
| S-EPMC6437613 | biostudies-literature
Project description:ObjectiveA weight loss maintenance trial involving weight loss prior to randomization is challenging to implement due to the potential for dropout and insufficient weight loss. We examined rates and correlates of non-initiation, dropout, and insufficient weight loss during a weight loss maintenance trial.MethodsThe MAINTAIN trial involved a 16-week weight loss program followed by randomization among participants losing at least 4 kg. Psychosocial measures were administered during a screening visit. Weight was obtained at the first group session and 16 weeks later to determine eligibility for randomization.ResultsOf 573 patients who screened as eligible, 69 failed to initiate the weight loss program. In adjusted analyses, failure to initiate was associated with lower age, lack of a support person, and less encouragement for making dietary changes. Among participants who initiated, 200 dropped out, 82 lost insufficient weight, and 222 lost sufficient weight for randomization. Compared to losing sufficient weight, dropping out was associated with younger age and tobacco use, whereas losing insufficient weight was associated with non-White race and controlled motivation for physical activity.ConclusionsStudies should be conducted to evaluate strategies to maximize recruitment and retention of subgroups that are less likely to initiate and be retained in weight loss maintenance trials.
| S-EPMC5192533 | biostudies-literature