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Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt

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ClinicalTrials.gov Identifier: NCT03903874
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : July 20, 2020
Sponsor:
Information provided by (Responsible Party):
Dorothy Pekmezi, PhD, University of Alabama at Birmingham

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).


Condition or disease Intervention/treatment Phase
Physical Activity Behavioral: Deep south Interactive voice response system supported Active Lifestyle (DIAL) Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: assessment staff will be blind to condition
Primary Purpose: Prevention
Official Title: Testing Scalable, IVR-supported Cancer Prevention Interventions in the Rural Alabama Black Belt
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : June 30, 2023
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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.
Behavioral: Deep south Interactive voice response system supported Active Lifestyle (DIAL)
12 months of automated telephone physical activity counseling with community health worker support

No Intervention: 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.



Primary Outcome Measures :
  1. changes in physical activity (as measured by 7-Day Physical Activity Recall interview) [ Time Frame: baseline, 6 months, 12 months, 18 months ]
    This interviewer-administered instrument estimates min/week of physical activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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Responsible Party: Dorothy Pekmezi, PhD, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03903874    
Other Study ID Numbers: CA233550
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No