Trial Outcomes & Findings for Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt (NCT NCT03903874)
NCT ID: NCT03903874
Last Updated: 2026-04-21
Results Overview
Changes in min/week of moderate-vigorous intensity physical activity from baseline to 6 months, based on 7-Day Physical Activity Recall interviews
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
245 participants
Primary outcome timeframe
baseline, 6 months, 12 months, 18 months
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
DIAL Intervention
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.
Deep south Interactive voice response system supported Active Lifestyle (DIAL): 12 months of automated telephone physical activity counseling with community health worker support
|
Wait List Control
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.
|
|---|---|---|
|
Overall Study
STARTED
|
123
|
122
|
|
Overall Study
COMPLETED
|
108
|
110
|
|
Overall Study
NOT COMPLETED
|
15
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
Baseline characteristics by cohort
| Measure |
DIAL Intervention
n=123 Participants
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.
Deep south Interactive voice response system supported Active Lifestyle (DIAL): 12 months of automated telephone physical activity counseling with community health worker support
|
Wait List Control
n=122 Participants
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.
|
Total
n=245 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
69 Participants
n=13 Participants
|
73 Participants
n=13 Participants
|
142 Participants
n=26 Participants
|
|
Age, Categorical
>=65 years
|
54 Participants
n=13 Participants
|
49 Participants
n=13 Participants
|
103 Participants
n=26 Participants
|
|
Age, Continuous
|
59.41 years
STANDARD_DEVIATION 14.25 • n=13 Participants
|
59.27 years
STANDARD_DEVIATION 12.64 • n=13 Participants
|
59.34 years
STANDARD_DEVIATION 13.44 • n=26 Participants
|
|
Sex: Female, Male
Female
|
113 Participants
n=13 Participants
|
110 Participants
n=13 Participants
|
223 Participants
n=26 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=13 Participants
|
12 Participants
n=13 Participants
|
22 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=13 Participants
|
122 Participants
n=13 Participants
|
245 Participants
n=26 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Black or African American
|
119 Participants
n=13 Participants
|
120 Participants
n=13 Participants
|
239 Participants
n=26 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=13 Participants
|
2 Participants
n=13 Participants
|
6 Participants
n=26 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=26 Participants
|
|
Region of Enrollment
United States
|
123 participants
n=13 Participants
|
122 participants
n=13 Participants
|
245 participants
n=26 Participants
|
PRIMARY outcome
Timeframe: baseline, 6 months, 12 months, 18 monthsPopulation: intent to treat analysis
Changes in min/week of moderate-vigorous intensity physical activity from baseline to 6 months, based on 7-Day Physical Activity Recall interviews
Outcome measures
| Measure |
DIAL Intervention
n=123 Participants
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.
Deep south Interactive voice response system supported Active Lifestyle (DIAL): 12 months of automated telephone physical activity counseling with community health worker support
|
Wait List Control
n=120 Participants
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.
|
|---|---|---|
|
Changes in Moderate-vigorous Intensity Physical Activity
|
67.35 min/week of physical activity
Interval 45.43 to 89.28
|
4.09 min/week of physical activity
Interval -17.34 to 25.53
|
Adverse Events
DIAL Intervention
Serious events: 6 serious events
Other events: 10 other events
Deaths: 1 deaths
Wait List Control
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
DIAL Intervention
n=123 participants at risk
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.
Deep south Interactive voice response system supported Active Lifestyle (DIAL): 12 months of automated telephone physical activity counseling with community health worker support
|
Wait List Control
n=122 participants at risk
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.
|
|---|---|---|
|
General disorders
hospitalized
|
0.81%
1/123 • Number of events 1 • 18 months
|
0.00%
0/122 • 18 months
|
|
Renal and urinary disorders
kidney transplant
|
0.81%
1/123 • Number of events 1 • 18 months
|
0.00%
0/122 • 18 months
|
|
Musculoskeletal and connective tissue disorders
bursitis, bulging disc; hand
|
1.6%
2/123 • Number of events 2 • 18 months
|
0.00%
0/122 • 18 months
|
|
Cardiac disorders
high blood pressure, triple bypass, stroke
|
1.6%
2/123 • Number of events 2 • 18 months
|
0.82%
1/122 • 18 months
|
Other adverse events
| Measure |
DIAL Intervention
n=123 participants at risk
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.
Deep south Interactive voice response system supported Active Lifestyle (DIAL): 12 months of automated telephone physical activity counseling with community health worker support
|
Wait List Control
n=122 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back, spine, shoulder, knee, ankle, foot, hip
|
8.1%
10/123 • Number of events 10 • 18 months
|
11.5%
14/122 • Number of events 14 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place