Clinical trial NCT03903874: Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
Official title: Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-04-04
Enrollment: 245
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

This proposal tests an intervention which acts on multiple levels of the socio-ecological model and uses IVR technology to enhance the potential for scaling and sustainability for broad use in populations at high risk for sedentary behavior (residents of rural Black counties in the Deep South).

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.

This proposal tests an intervention which acts on multiple levels of the socio-ecological model and uses IVR technology to enhance the potential for scaling and sustainability for broad use in populations at high risk for sedentary behavior (residents of rural Black counties in the Deep South).

Eligibility criteria: Inclusion Criteria:

* Insufficiently active (engaging in MVPA \< 60 minutes per week)
* Residents of participating rural Black Belt counties (Dallas, Marengo, Choctaw, Sumter, Hale, Greene)
* BMI 18.5-45
* 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.

Primary outcomes:
measure: changes in physical activity (as measured by 7-Day Physical Activity Recall interview)
timeFrame: baseline, 6 months, 12 months, 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama At Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Dorothy Pekmezi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown NI, Powell MA, Baskin M, Oster R, Demark-Wahnefried W, Hardy C, Pisu M, Thirumalai M, Townsend S, Neal WN, Rogers LQ, Pekmezi D. Design and Rationale for the Deep South Interactive Voice Response System-Supported Active Lifestyle Study: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 May 25;10(5):e29245. doi: 10.2196/29245.