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The Recruitment Experience of a Randomized Clinical Trial to Aid Young Adult Smokers to Stop Smoking without Weight Gain with Interactive Technology.

ABSTRACT: Multiple 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/m^2, 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.

SUBMITTER: Coday M

PROVIDER: S-EPMC4772746 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:eHealth interventions are effective for weight control and have the potential for broad reach. Little is known about the use of interactive voice response (IVR) technology for self-monitoring in weight control interventions, particularly among populations disproportionately affected by obesity.This analysis sought to examine patterns and predictors of IVR self-monitoring adherence and the association between adherence and weight change among low-income black women enrolled in a weight gain prevention intervention.The Shape Program was a randomized controlled trial comparing a 12-month eHealth behavioral weight gain prevention intervention to usual care among overweight and obese black women in the primary care setting. Intervention participants (n=91) used IVR technology to self-monitor behavior change goals (eg, no sugary drinks, 10,000 steps per day) via weekly IVR calls. Weight data were collected in clinic at baseline, 6, and 12 months. Self-monitoring data was stored in a study database and adherence was operationalized as the percent of weeks with a successful IVR call.Over 12 months, the average IVR completion rate was 71.6% (SD 28.1) and 52% (47/91) had an IVR completion rate ?80%. At 12 months, IVR call completion was significantly correlated with weight loss (r =-.22; P=.04) and participants with an IVR completion rate ?80% had significantly greater weight loss compared to those with an IVR completion rate <80% (-1.97 kg, SE 0.67 vs 0.48 kg, SE 0.69; P=.01). Similar outcomes were found for change in body mass index (BMI; mean difference -0.94 kg, 95% CI -1.64 to -0.24; P=.009). Older, more educated participants were more likely to achieve high IVR call completion. Participants reported positive attitudes toward IVR self-monitoring.Adherence to IVR self-monitoring was high among socioeconomically disadvantaged black women enrolled in a weight gain prevention intervention. Higher adherence to IVR self-monitoring was also associated with greater weight change. IVR is an effective and useful tool to promote self-monitoring and has the potential for widespread use and long-term sustainability.Clinicaltrials.gov NCT00938535; http://www.clinicaltrials.gov/ct2/show/NCT00938535.

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The Recruitment Experience of a Randomized Clinical Trial to Aid Young Adult Smokers to Stop Smoking without Weight Gain with Interactive Technology.

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