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Rationale, design, and baseline findings from a pilot randomized trial of an IVR-Supported physical activity intervention for cancer prevention in the Deep South: the DIAL study.

ABSTRACT: Telephone-delivered interventions do not require frequent clinic visits, literacy, or costly technology and thus may represent promising approaches to promoting physical activity in the Deep South, a largely rural U.S. region, with generally lower physical activity, income, and education levels. Building on past Interactive Voice Response (IVR) system-based HIV studies and extensive formative research (11 focus groups on physical activity intervention needs/preferences in the Deep South), the resulting IVR-supported physical activity intervention is now being tested in a randomized controlled trial with a waitlist control. The sample (n=63) includes mostly obese (Mean BMI=30.1) adults (Mean age=43 years) in Birmingham, AL. Both genders (55.6% male) and African Americans (58.7%) are well-represented. Most participants reported at least some college (92%), full time employment (63.5%), and household income <$50,000 per year (61.9%). Baseline physical activity (Mean=39.6 minutes/week, SD=56.4), self-efficacy, self-regulation, and social support were low. However, high physical activity enjoyment and outcome expectations bode well. Self-report physical activity was associated with physical activity enjoyment (r=.36) and social support (friends r=.25, p's<.05) at baseline. Consequently, these may be important variables to emphasize in our program. Depression and anxiety were negatively correlated with some early indicators of behavior change (e.g., physical activity self-regulation; r's =-.43 and -.46, respectively, p's<.01) and thus may require additional attention. Such technology-supported strategies have great potential to reach underserved populations and address physical activity-related health disparities in this region.

SUBMITTER: Pekmezi D

PROVIDER: S-EPMC5830176 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature

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Rationale, design, and baseline findings from a pilot randomized trial of an IVR-Supported physical activity intervention for cancer prevention in the Deep South: the DIAL study.

Pekmezi Dori D Ainsworth Cole C Holly Taylor T Williams Victoria V Benitez Tanya T Wang Kaiying K Rogers Laura Q LQ Marcus Bess B Demark-Wahnefried Wendy W

Contemporary clinical trials communications 20171102

Telephone-delivered interventions do not require frequent clinic visits, literacy, or costly technology and thus may represent promising approaches to promoting physical activity in the Deep South, a largely rural U.S. region, with generally lower physical activity, income, and education levels. Building on past Interactive Voice Response (IVR) system-based HIV studies and extensive formative research (11 focus groups on physical activity intervention needs/preferences in the Deep South), the re ...[more]

PMID: 29503878

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Project description:There is a significant resumption of smoking following smoking cessation using varenicline. Both smoking cessation medications and counseling have been shown to increase smoking quit rates at one year. Thus, the combination of varenicline and interactive voice response (IVR) telephony followed by extended IVR may further improve smoking cessation rates at one and two years.101 participants were recruited from the community via newspaper advertisement. They attended a group counseling session and were given smoking information booklets from the Canadian Cancer Society. After 12 weeks of varenicline and 9 IVR calls, all participants who had quit smoking were randomized into 2 groups matched by levels of motivation and addiction as per baseline questionnaire score. The intervention group continued to receive bi-weekly IVR support for weeks 13-52. The control group no longer received IVR. The primary end-point was self-reported abstinence and exhaled carbon monoxide levels of less than 10 ppm for weeks 12, 52 and 2 years. Data were analyzed by Fisher's exact test or Wilcoxon rank-sum test.Of the 101 participants, 44 (43%) had stopped smoking after 12 weeks of varenicline and 9 IVR calls. Of these, 23 (52%) were randomized to receive IVR calls from weeks 13 to 52.At 52 weeks, 26 (59%) participants remained smoke-free. Of the 23 with IVR, 12 (52.2%) stopped smoking compared to 14 of 21 (66.7%) without IVR. At 2 years, 40 of the 44 (90.9%) randomized participants were contacted and 24 of the 44 (54.5%) came in for testing. Fourteen (13% of the original cohort, 30% who were abstinent at 12 weeks and 53% who were abstinent at 52 weeks) remained smoke-free. Five of the 23 (21.7%) randomized to IVR and 9 of the 21 (42.9%) randomized to no IVR remained smoke-free at 2 years.In this pilot study of an apparently healthy population, extended IVR did not affect abstinence rates. There was no relapse prevention benefit in offering 9 months of continued IVR to subjects who had stopped smoking after receiving 3 months of varenicline and IVR treatment.ClinicalTrial.gov: NCT00832806.

Project description:BackgroundThe rates of physical inactivity and related cancer incidence and mortality are disproportionately high in the Deep South region in the United States, a rural, medically underserved region with a large African American population compared with the rest of the nation. Given this region's lower rates of literacy and internet access, interactive voice response (IVR) system-automated telephone-based interventions have the potential to help overcome physical activity intervention barriers (literacy, internet access, costs, and transportation) but have yet to be extended to rural, underserved populations, such as in the Deep South. Thus, extensive formative research is being conducted to develop and beta test the Deep South IVR System-Supported Active Lifestyle intervention in preparation for dissemination in rural Alabama counties.ObjectiveThis paper aims to describe the design and rationale of an ongoing efficacy trial of the Deep South IVR System-Supported Active Lifestyle intervention.MethodsA two-arm randomized controlled trial will be conducted to compare a 12-month physical activity intervention versus a wait-list control condition in 240 underactive adults from 6 rural Alabama counties. The Deep South IVR System-Supported Active Lifestyle intervention is based on the Social Cognitive Theory and includes IVR-automated physical activity-related phone counseling (daily in months 0-3, twice weekly in months 4-6, and weekly in months 7-12) and support from local rural county coordinators with the University of Alabama O'Neal Comprehensive Cancer Center Community Outreach and Engagement Office. The primary outcome is weekly minutes of moderate- to vigorous-intensity physical activity (7-day physical activity recall; accelerometry) at baseline, 6 months, 12 months, and 18 months. Rural Active Living Assessments will be conducted in each rural county to assess walkability, assess recreational amenities, and inform future environment and policy efforts.ResultsThis study was funded in March 2019 and approved by the institutional review board of the University of Alabama at Birmingham in April 2019. As of February 2020, start-up activities (hiring and training staff and purchasing supplies) were completed. Study recruitment and assessments began in September 2020 and are ongoing. As of February 2021, a total of 43 participants have been enrolled in Dallas County, 42 in Sumter County, and 51 in Greene County.ConclusionsIVR-supported phone counseling has great potential for addressing physical activity barriers (eg, culture, literacy, cost, or transportation) and reducing related rural health disparities in this region.Trial registrationClinicalTrials.gov NCT03903874; https://clinicaltrials.gov/ct2/show/NCT03903874.International registered report identifier (irrid)DERR1-10.2196/29245.

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Project description:Regular exercise protects against overweight/obesity as well as numerous chronic diseases. Yet, less than half of Americans exercise sufficiently. Elevated levels of depressive symptoms have been identified as an important correlate of physical inactivity as well as poor adherence to exercise programs. Individuals with depression are less sensitive to rewards and demonstrate an attentional bias toward negative stimuli. These, and other features of depression, may place them at increased risk for effectively managing the affective experience of exercise. Lower baseline levels of activation of the left (vs right) frontal cortex, an area implicated in affect regulation, have also been found in depression, potentially pointing to this region as a potential target for intervening on affect regulation during exercise. Transcranial direct current stimulation (tDCS) has shown promise in impacting a variety of cognitive and affective processes in a large number of individuals, including people with depression. Some findings have suggested that tDCS targeting the left dorsolateral prefrontal cortex (DLPFC), specifically, may improve emotion regulation. Transcranial direct current stimulation could theoretically be a novel and potentially promising approach to improving the affective experience of exercise, thereby increasing exercise adherence among individuals with depressive symptoms. Here we present the rationale, design, and baseline characteristics of a pilot randomized controlled trial of tDCS versus sham delivered 3x/week for 8 weeks in the context of supervised aerobic exercise (AE) program among 51 low-active individuals with elevated depressive symptoms (86.3% female; mean age = 49.5). Follow-up assessments were conducted at end of treatment, and three and six months after enrollment to examine changes in levels of objectively-measured moderate-to-vigorous physical activity (MVPA). If effective, this approach could have high public health impact on preventing obesity and chronic diseases among these at-risk individuals.

Dataset Information

Rationale, design, and baseline findings from a pilot randomized trial of an IVR-Supported physical activity intervention for cancer prevention in the Deep South: the DIAL study.

Publications

Rationale, design, and baseline findings from a pilot randomized trial of an IVR-Supported physical activity intervention for cancer prevention in the Deep South: the DIAL study.

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