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IVR-Supported Physical Activity Counseling for Increasing Physical Activity
N/A
Recruiting
Led By Dorothy Pekmezi, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
BMI 18.5-45
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 months, 12 months, 18 months
Awards & highlights
Study Summary
This trial is testing the efficacy of a physical activity counseling intervention vs. a wait list control. The goal is to see if the intervention increases physical activity in the participants.
Who is the study for?
This trial is for adults with a BMI of 18.5-45 who are not very active, living in specific rural Alabama counties, and can use a phone regularly. They should speak English and be open to random group assignment. People planning to move or with serious health issues that make exercise unsafe cannot join.Check my eligibility
What is being tested?
The study tests the DIAL intervention, which uses phone calls to encourage more physical activity against a wait list control group. Participants' activity levels and psychosocial factors are measured over 18 months to see if those getting calls become more active.See study design
What are the potential side effects?
Since this trial promotes physical activity through counseling calls, there aren't direct medical side effects like with drugs or surgery. However, increasing exercise suddenly could cause muscle soreness or strain for some participants.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 18.5 and 45.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 months, 12 months, 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 months, 12 months, 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
changes in physical activity (as measured by 7-Day Physical Activity Recall interview)
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DIAL interventionExperimental Treatment1 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.
Group II: Wait List ControlActive Control1 Intervention
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.
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,242 Total Patients Enrolled
Dorothy Pekmezi, PhDPrincipal Investigator - University of Alabama at Birmingham
University of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You do not engage in enough physical activity, which means less than 60 minutes of moderate to vigorous exercise per week.My BMI is between 18.5 and 45.I am willing to follow the study's rules and accept any assigned treatment group.I do not have serious health issues that make physical activity unsafe.
Research Study Groups:
This trial has the following groups:- Group 1: DIAL intervention
- Group 2: Wait List Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Physical Activity Patient Testimony for trial: Trial Name: NCT03903874 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are participating in the experiment?
"Affirmative. Clinicaltrials.gov provides evidence that this medical trial, which went live on September 9th 2020, is currently recruiting participants. 240 individuals must be enrolled from a single location for the study to proceed."
Answered by AI
Are enrollees still being accepted for this research experiment?
"The clinical trial is still looking for appropriate individuals to enrol. As per the records on clinicaltrials.gov, this project was initially advertised on September 9th 2020 and modified most recently on April 21st 2022."
Answered by AI
Who else is applying?
What state do they live in?
Alabama
What site did they apply to?
University of Alabama At Birmingham
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
Currently doing nothing for my medical condition.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
Is this a paid trial?
PatientReceived 1 prior treatment
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