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Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost.

ABSTRACT: 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).

SUBMITTER: Tate DF

PROVIDER: S-EPMC4150977 | biostudies-literature | 2014 Aug

REPOSITORIES: biostudies-literature

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Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost.

Tate Deborah F DF LaRose Jessica G JG Griffin Leah P LP Erickson Karen E KE Robichaud Erica F EF Perdue Letitia L Espeland Mark A MA Wing Rena R RR

Trials 20140816

<h4>Background</h4>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).<h4>Methods</h4>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 ag ...[more]

PMID: 25128185

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Project description:BACKGROUND:Recruiting 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. METHODS:For 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. RESULTS:The 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). CONCLUSIONS:These 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 REGISTRATION:The Study of Novel Approaches to Weight Gain Prevention was registered with ClinicalTrials.gov (identifier: NCT01183689 ) on 13 August 2010.

Project description:BackgroundWeight gain during young adulthood is common and is associated with increased cardiovascular risk. Preventing this weight gain from occurring may be critical to improving long-term health. Few studies have focused on weight gain prevention, and these studies have had limited success. SNAP (Study of Novel Approaches to Weight Gain Prevention) is an NIH-funded randomized clinical trial examining the efficacy of two novel self-regulation approaches to weight gain prevention in young adults compared to a minimal treatment control. The interventions focus on either small, consistent changes in eating and exercise behaviors, or larger, periodic changes to buffer against expected weight gains.Methods/designSNAP targets recruitment of six hundred young adults (18-35 years) with a body mass index between 21.0-30.0 kg/m2, who will be randomly assigned with equal probability to: (1) minimal intervention control; (2) self-regulation with Small Changes; or (3) self-regulation with Large Changes. Both interventions receive 8 weekly face-to-face group sessions, followed by 2 monthly sessions, with two 4-week refresher courses in each of subsequent years. Participants are instructed to report weight via web at least monthly thereafter, and receive monthly email feedback. Participants in Small Changes are taught to make small daily changes (~100 calorie changes) in how much or what they eat and to accumulate 2000 additional steps per day. Participants in Large Changes are taught to create a weight loss buffer of 5-10 pounds once per year to protect against anticipated weight gains. Both groups are encouraged to self-weigh daily and taught a self-regulation color zone system that specifies action depending on weight gain prevention success. Individualized treatment contact is offered to participants who report weight gains. Participants are assessed at baseline, 4 months, and then annually. The primary outcome is weight gain over an average of 3 years of follow-up; secondary outcomes include diet and physical activity behaviors, psychosocial measures, and cardiovascular disease risk factors.DiscussionSNAP is unique in its focus on weight gain prevention in young adulthood. The trial will provide important information about whether either or both of these novel interventions are effective in preventing weight gain.Trial registrationClinicalTrials.gov, NCT01183689.

Project description:IMPORTANCE:Weight gain occurs commonly in young adults and has adverse effects on health. OBJECTIVE:To compare 2 self-regulation interventions vs control in reducing weight gain in young adults over a mean follow-up of 3 years. DESIGN, SETTING, AND PARTICIPANTS:Randomized clinical trial in 2 academic settings of 599 participants aged 18 to 35 years with body mass index (BMI, calculated as weight in kilograms divided by height in meters squared) of 21.0 to 30.0, recruited via mailings and emails from August 2010 to February 2012. Data were analyzed from January 2015 to January 2016. INTERVENTIONS:Participants were randomized to control, self-regulation plus small changes, or self-regulation plus large changes. Both interventions focused on frequent self-weighing to cue behavior changes. "Small changes" taught participants to reduce intake and increase activity, both by approximately 100 calories per day. "Large changes" focused on losing 2.3 to 4.5 kg initially to buffer against expected weight gain. MAIN OUTCOMES AND MEASURES:Changes in weight from baseline over mean follow-up of 3 years. Secondary outcomes included proportion gaining at least 0.45 kg from baseline, proportion developing obesity (BMI, ?30.0), and weight change baseline to 2 years. RESULTS:Among the 599 participants (22% men; 27% minority; mean [SD] age, 27.7 [4.4] years; mean [SD] BMI, 25.4 [2.6]), mean (SE) weight changes over a mean follow-up of 3 years were 0.26 (0.22), -0.56 (0.22), and -2.37 (0.22) kg in the control, small-changes, and large-changes groups, respectively (P?<?.001). Differences among all 3 groups were significant (large changes vs control, P?<?.001; small changes vs control, P?=?.02; large changes vs small changes, P?<?.001). On secondary outcomes, both interventions significantly reduced incidence of obesity relative to control (mean [SE], 8.6% [2.0%], 7.9% [2.0%], and 16.9% [2.7%] in the large-changes, small-changes, and control groups, respectively; P?=?.02 for large changes vs control and P?=?.002 for small changes vs control); a smaller percentage of participants in the large-changes group gained 0.45 kg or more (mean [SE], 23.6% [2.8%], 32.5% [3.8%], and 40.8% [4.4%], respectively; P?<?.001 vs control and P?=?.02 vs small changes) and weight change from baseline to 2 years was greater in control than in small or large changes (mean [SE], 0.54 [0.33], -0.77 [0.33], and -1.50 [0.34] kg, respectively; P?=?.02 vs small changes and P?<?.001 vs large changes). CONCLUSIONS AND RELEVANCE:Self-regulation with large or small changes both reduced weight gain in young adults over 3 years relative to control, but the large-changes intervention was more effective. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01183689.

Project description:ObjectivesThe purpose of this review was to use RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) to assess the extent to which weight gain prevention studies targeting young adults reported on elements of external validity.DesignSystematic review.Eligibility criteriaArticles of interest included a lifestyle/behavioral intervention targeting weight gain prevention. Eligibility criteria included the following: study design of randomized controlled trials, quasi-randomized control trials, or natural experiments; average participant age between 18 and 35 years; study duration of at least 12 months; and published in English between January 2008 and May 2018. Studies had to report weight or body mass index as a measured outcome and were excluded if they were paired with smoking cessation programs, were conducted in specific groups (ie, pregnant women, breast cancer survivors), or were follow-ups to weight loss studies.Study selectionAfter removing duplicates, the search yielded 11426 articles. Titles and abstracts were screened by 1 reviewer; 144 articles were assessed in a full-text review by 2 reviewers. Discrepancies were resolved by consensus. Nine studies (13 articles) were included in the review.Main outcomes measuresReported elements of the RE-AIM framework.ResultsA total of 9 studies met the selection criteria. All studies lacked full reporting on external validity elements. Of the total of 60 RE-AIM reporting criteria, 8 were reported by all 9 studies, 26 criteria were reported by fewer than 4 studies, and 22 criteria were not reported by any of the studies.DiscussionThere remains inadequate reporting of elements of external validity and generalizability in weight gain prevention studies. This is a significant scientific constraint that limits the information required to disseminate and implement prevention of weight gain interventions for population impact. Standardized reporting may be needed to ensure results that demonstrate not only internal validity but also external validity and generalizability are needed to promote public health impact.

Project description:Body weight (BW) reduction through energy restriction is ineffective at impacting the obesity epidemic. Shifting from an obesity treatment to weight gain prevention focus may be more effective in decreasing the burden of adult obesity.This was a 1-year randomized controlled trial of weight gain prevention in healthy premenopausal women, aged 18-45 y, with a body mass index (BMI) of >18.5 kg/m(2). Eighty-seven women were randomized to a weight gain prevention intervention delivered by a registered dietitian (RDG) or counselor (CSG), or to a control (CON) group. Eighty-one women (mean ± SD, age: 31.4 ± 8.1 y; BW: 76.1 ± 19.0 kg; BMI: 27.9 ± 6.8 kg/m(2)) completed baseline testing and were included in intention-to-treat analyses; anthropometric, blood pressure, dietary intake and physical activity measurements and biochemical markers of health were measured every three months. Data were analyzed using repeated measures ANCOVA, with significance at P < 0.01.Sixty-two percent of women met the weight gain prevention criteria (BW change within ±3 %) after one year; this did not differ by group assignment. Body fat % was lower in the RDG versus CSG and CON groups at all intervals (P < 0.001). Systolic blood pressure increased from month 6 to 9 and decreased from month 6 to 12 in the CON group (P < 0.001), with a significant group x time interaction (P < 0.01). Estimated carbohydrate intake (%) was higher in the RDG vs. CON group at month 9 (P < 0.01); fat intake (%) was lower in the RDG vs. CON group and CSG vs. CON group at months 3 and 9, respectively (P < 0.01). Estimated fruit intake (svgs/d) was higher in the RDG vs. CON group at months 3, 6, 9 and 12 (P < 0.01), and non-meat protein sources (svgs/d) was higher in the RDG vs. CSG and CON groups at month 3 (P < 0.001). Estimated energy, macronutrient and food group intakes did not change over time.A majority of all participants maintained BW over one year and were able to do so regardless of whether they received nutrition education. Additional studies that include a variety of clinical outcomes are needed to evaluate further aspects of nutrition education on weight gain prevention and health status over the long term.

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Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost.

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Recruitment of young adults into a randomized controlled trial of weight gain prevention: message development, methods, and cost.

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