Physical Activity
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDeep south Interactive voice response system supported Active Lifestyle (DIAL)
12 months of automated telephone physical activity counseling with community health worker support
Sponsors
University of Alabama at Birmingham
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
assessment staff will be blind to condition
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Insufficiently active (engaging in MVPA \< 60 minutes per week) * Residents of participating rural Black Belt counties (Dallas, Marengo, Choctaw, Sumter, Hale, Greene) * Able to speak and read English * Willing to be randomized to either study arm and adhere to study protocol * Able to regularly access a telephone (own a cell phone or work/home landline) to complete IVR calls
Exclusion criteria
* Serious medical conditions that would make physical activity unsafe (history of heart disease, myocardial infarction, angina, stroke, orthopedic conditions which limit mobility), * Planning to move from the area within the next 18 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Moderate-vigorous Intensity Physical Activity | baseline, 6 months, 12 months, 18 months | Changes in min/week of moderate-vigorous intensity physical activity from baseline to 6 months, based on 7-Day Physical Activity Recall interviews |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDorothy Pekmezi, PhD
University of Alabama at Birmingham
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 123 |
| 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. | 122 |
| Total | 245 |
Baseline characteristics
| Characteristic | DIAL intervention | Wait List Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 54 Participants | 49 Participants | 103 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants | 73 Participants | 142 Participants |
| Age, Continuous | 59.41 years STANDARD_DEVIATION 14.25 | 59.27 years STANDARD_DEVIATION 12.64 | 59.34 years STANDARD_DEVIATION 13.44 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 123 Participants | 122 Participants | 245 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 119 Participants | 120 Participants | 239 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 2 Participants | 6 Participants |
| Region of Enrollment United States | 123 participants | 122 participants | 245 participants |
| Sex: Female, Male Female | 113 Participants | 110 Participants | 223 Participants |
| Sex: Female, Male Male | 10 Participants | 12 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 123 | 0 / 122 |
| other Total, other adverse events | 10 / 123 | 14 / 122 |
| serious Total, serious adverse events | 6 / 123 | 1 / 122 |
Outcome results
Primary
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
Population: intent to treat analysis
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| DIAL intervention | Changes in Moderate-vigorous Intensity Physical Activity | 67.35 min/week of physical activity |
| Wait List Control | Changes in Moderate-vigorous Intensity Physical Activity | 4.09 min/week of physical activity |