An interventional study of Deep south Interactive voice response system supported Active Lifestyle (DIAL) in Physical Activity, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention
This protocol involves a randomized controlled trial (N=240) to test the efficacy of the Deep south Active Lifestyle (DIAL intervention) telephone-based physical activity counseling intervention vs. a wait list condition. Assessments of MVPA and psychosocial variables will occur at baseline, 6, 12, and 18 months. Primary aim. Test the efficacy of DIAL intervention vs. wait list control. Hypotheses are that the participants receiving DIAL intervention will report significantly greater increases in MVPA (based on 7-Day Physical Activity Recalls, accelerometers) from baseline to 6 and 12 months than the wait list control arm. Exploratory Aims. Examine 1) Intervention effects on physical performance and psychosocial variables (anxiety, depression, fatigue, sleep disturbance; corroborate self report sleep improvements from pilot with accelerometry); 2) Changes in MVPA from 12-18 months to assess long term (6 months post-intervention) maintenance in the intervention arm and ascertain replicability of intervention effects in wait list control arm; 3) Intervention costs; 4) Potential mediators (social support from family, friends, CHAs, theoretical constructs directly targeted by the intervention) and moderators (education, neighborhood/environmental features) of treatment efficacy; 5) Potential barriers/ facilitators to widespread implementation of DIAL intervention in rural Black belt counties by Deep South Network for Cancer Control.
This protocol involves a randomized controlled trial (N=240) to test the efficacy of the Deep south Active Lifestyle (DIAL intervention) telephone-based physical activity counseling intervention vs. a wait list condition. Assessments of MVPA and psychosocial variables will occur at baseline, 6, 12, and 18 months.
Primary aim. Test the efficacy of DIAL intervention vs. wait list control. Hypotheses are that the participants receiving DIAL intervention will report significantly greater increases in MVPA (based on 7-Day Physical Activity Recalls, accelerometers) from baseline to 6 and 12 months than the wait list control arm.
Exploratory Aims. Examine 1) Intervention effects on physical performance and psychosocial variables (anxiety, depression, fatigue, sleep disturbance; corroborate self report sleep improvements from pilot with accelerometry); 2) Changes in MVPA from 12-18 months to assess long term (6 months post-intervention) maintenance in the intervention arm and ascertain replicability of intervention effects in wait list control arm; 3) Intervention costs; 4) Potential mediators (social support from family, friends, CHAs, theoretical constructs directly targeted by the intervention) and moderators (education, neighborhood/environmental features) of treatment efficacy; 5) Potential barriers/ facilitators to widespread implementation of DIAL intervention in rural Black belt counties by Deep South Network for Cancer Control.
2,426 studies on the registry are indexed under Motor Activity; 1,161 are open to participants now.
This study's enrollment of 245 is above the median of 60 across 2,118 interventional studies indexed under Motor Activity.
Browse Motor Activity studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Deep south Interactive voice response system Active Lifestyle (DIAL) intervention. Participants will receive 12 months of automated physical activity phone counseling. Participants will report their physical activity to the IVR system each day for 3 months, twice/week in months 3-6, and once/week in months 6-12 and receive progress feedback via IVR system, along with community health worker support.
Behavioral: Deep south Interactive voice response system supported Active Lifestyle (DIAL)
The wait list control participants will be instructed to maintain their normal routine until completion of the 6-month assessments and then receive the same 12-month DIAL intervention. To maintain engagement, these participants will be involved in monthly lunch and learns, focus groups, etc on cancer topics other than PA (e.g., screening) during the wait period.
12 months of automated telephone physical activity counseling with community health worker support
Changes in Moderate-vigorous Intensity Physical Activity
Changes in min/week of moderate-vigorous intensity physical activity from baseline to 6 months, based on 7-Day Physical Activity Recall interviews
Time frame: baseline, 6 months, 12 months, 18 months
| Milestone | DIAL Intervention | Wait List Control |
|---|---|---|
| Started | 123 | 122 |
| Completed | 108 | 110 |
| Not completed | 15 | 12 |
Changes in min/week of moderate-vigorous intensity physical activity from baseline to 6 months, based on 7-Day Physical Activity Recall interviews
| min/week of physical activity | DIAL Intervention | Wait List Control |
|---|---|---|
| Changes in Moderate-vigorous Intensity Physical Activity | 67.35 (45.43 to 89.28) | 4.09 (-17.34 to 25.53) |
Collected over 18 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DIAL Intervention | 1/123 (0.8%) | 6/123 (4.9%) | 10/123 (8.1%) |
| Wait List Control | 0/122 (0%) | 1/122 (0.8%) | 14/122 (11.5%) |
| Event | DIAL Intervention | Wait List Control |
|---|---|---|
| bursitis, bulging disc; handMusculoskeletal and connective tissue disorders | 2/123 | 0/122 |
| high blood pressure, triple bypass, strokeCardiac disorders | 2/123 | 1/122 |
| hospitalizedGeneral disorders | 1/123 | 0/122 |
| kidney transplantRenal and urinary disorders | 1/123 | 0/122 |
| Event | DIAL Intervention | Wait List Control |
|---|---|---|
| Back, spine, shoulder, knee, ankle, foot, hipMusculoskeletal and connective tissue disorders | 10/123 | 14/122 |
| Age, Categorical(Participants) | DIAL Intervention | Wait List Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 69 | 73 | 142 |
| >=65 years | 54 | 49 | 103 |
| Age, Continuous(years) | DIAL Intervention | Wait List Control | Total |
|---|---|---|---|
| Mean | 59.41 ± 14.25 | 59.27 ± 12.64 | 59.34 ± 13.44 |
| Sex: Female, Male(Participants) | DIAL Intervention | Wait List Control | Total |
|---|---|---|---|
| Female | 113 | 110 | 223 |
| Male | 10 | 12 | 22 |
| Ethnicity (NIH/OMB)(Participants) | DIAL Intervention | Wait List Control | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 123 | 122 | 245 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | DIAL Intervention | Wait List Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 119 | 120 | 239 |
| White | 4 | 2 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | DIAL Intervention | Wait List Control | Total |
|---|---|---|---|
| United States | 123 | 122 | 245 |
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University of Alabama at Birmingham