- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04088552
Preventing Chronic Disease: ActuaYa
October 12, 2021 updated by: Rosina Cianelli, University of Miami
Preventing Chronic Disease (HIV, Diabetes, Hypertension, Obesity) Among Older Hispanic Women in Broward
The purpose of the study is to help older Hispanic women to increase physical activity, reach a healthy body weight, increase self-esteem and mood and increase knowledge about chronic diseases such as hypertension, diabetes, and HIV.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Miami, Florida, United States, 33146
- University of Miami
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria
- Must self-identify as a Hispanic woman
- Must be aged 50 years or older
- Must not already be engaging in exercise for >150 minutes per week
- Must be able to ambulate without the use of assistive devices
- Must have an intelligent phone iOS or Android
- Must be willing and able to participate in the informed consent process.
Exclusion Criteria
- Participants that do not meet the above-mentioned criteria.
- In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate.
- Participants who are currently participating in another investigational study.
- Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ActuaYa Arm
Participants will receive educational sessions, facilitated discussions and an exercise program.
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The Go4Life-Physical Activity/Exercise Program "Workout to Go" 5 Program is an exercise regimen provided to participants.
Participants will be provided a booklet with exercise routines that requires minimal equipment and can be performed anywhere for approximately 30 minutes per session.
Recommendation on staying active by increasing daily steps through walking will also be recommended as part of the regimen.
The ActuaYa Educational Sessions will be delivered by a facilitator in 3 separate sessions with each session lasting 2.5 hours for a total of 7.5 hours administered for the study duration.
Each session will be conducted in separate groups of 6-10 participants.
Session 1 will discuss the impact of chronic disease in the older Hispanic community.
Session 2 will discuss the communication and negotiation with the family and partner.
Session 3 will discuss saying goodbye and having a plan for a healthy lifestyle.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in mean Hemoglobin A1C (HbA1c) levels
Time Frame: Baseline, 6 months
|
HbA1c will be measured from finger stick blood sample.
|
Baseline, 6 months
|
Change in Blood Pressure
Time Frame: Baseline, 6 months
|
Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.
|
Baseline, 6 months
|
Change in Body Mass Index (BMI)
Time Frame: Baseline, 6 months
|
BMI will be measured by weight and height using the formula: 703 multiplied by the weight in lbs divided by the square of height in inches.
|
Baseline, 6 months
|
Change in self-efficacy for condom use
Time Frame: Baseline, 6 months
|
Measured using the HIV self-efficacy for condom use survey.
Scores range from 7-28.
A higher score indicates a higher level of self-efficacy for condom use.
|
Baseline, 6 months
|
Change in nutritional habits
Time Frame: Baseline, 6 months
|
Change in nutritional habits will be evaluated via the Healthy Eating Index (HEI) using the self-reported data from the nutrition survey.
The HEI scores range from 0 to 100 with a higher score indicating healthier eating habits with food intake aligning with key dietary recommendations from the Dietary Guidelines for Americans.
|
Baseline, 6 months
|
Change in active lifestyle as assessed by daily steps
Time Frame: Baseline, 6 months
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Change in active lifestyle will be assessed by the amount of daily steps taken as assessed using a study provided wrist pedometer.
|
Baseline, 6 months
|
Change in active lifestyle as assessed by a self-report log
Time Frame: Baseline, 6 months
|
Change in active lifestyle will be assessed by the number of days per week the participant completed the recommended 30-minutes exercise via a self-report log.
|
Baseline, 6 months
|
Change in active lifestyle as assessed by the Exercise Survey
Time Frame: Baseline, 6 months
|
Change in active lifestyle will be assessed using the Exercise Survey.
The exercise survey is a 19-item survey with each item having a score ranging from 0-10.
A higher total score indicates a higher level of physical activity.
|
Baseline, 6 months
|
Change in active lifestyle as assessed by the Exercise Question Survey
Time Frame: Baseline, 6 months
|
Change in active lifestyle will be assessed using the Exercise Question Survey.
The exercise survey is a 9-item survey with total score ranging from 0-90.
A higher total score indicates a higher level of physical activity.
|
Baseline, 6 months
|
Change in HIV risk behaviors
Time Frame: Baseline, 6 months
|
Change in HIV risk behaviors will be assessed using the Partner Table Survey.
The Partner Table Survey is a 5-item survey with a total score ranging from 1-17 with a higher score indicating a higher HIV risk behavior.
|
Baseline, 6 months
|
Change in body fat composition
Time Frame: Baseline, 6 months
|
Measured using a bioelectrical impedance analysis.
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Baseline, 6 months
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Change in abdominal circumference
Time Frame: Baseline, 6 months
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Measured using a measuring tape.
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Baseline, 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in knowledge regarding obesity
Time Frame: Baseline, 6 months
|
Change in knowledge regarding obesity will be measured using the obesity knowledge and risk perception questionnaire.
For obesity knowledge, the scores range from 6-12.
A higher score indicates a lower level of obesity-related knowledge.
|
Baseline, 6 months
|
Change in risk perception regarding obesity
Time Frame: Baseline, 6 months
|
Change in risk perception regarding obesity will be measured using the obesity knowledge and risk perception questionnaire.
For obesity risk perception, the scores range from 3-9.
A higher score indicates a lower level of obesity risk perception.
|
Baseline, 6 months
|
Change in knowledge regarding diabetes
Time Frame: Baseline, 6 months
|
Change in diabetes knowledge will be measured using the Diabetes Knowledge Questionnaire (DKQ-24).
It is a 24 item questionnaire wherein a score of 17 or more correct responses indicate sufficient diabetes knowledge and a score of 6 or less correct responses indicate insufficient diabetes knowledge.
|
Baseline, 6 months
|
Change in HIV knowledge
Time Frame: Baseline, 6 months
|
Change in HIV knowledge will be measured via the HIV Knowledge Scale.
The score ranges from 0-12 with a higher score indicating a higher level of HIV-related knowledge.
|
Baseline, 6 months
|
Change in HIV risk perception
Time Frame: Baseline, 6 months
|
Change in HIV risk perception will be measured via the HIV Risk Perception Scale.
The total score ranges from 4-14 with a higher score indicating a higher level of HIV-related knowledge.
|
Baseline, 6 months
|
Change in self-esteem
Time Frame: Baseline, 6 months
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Change in self-esteem will be measured by the Rosenberg Self-Esteem Scale via interview.
The total score ranges from 0 to 30 with a score of 14 and less indicating low self-esteem.
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Baseline, 6 months
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Change in depressive symptoms as assessed by the CES-D20
Time Frame: Baseline, 6 months
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Change in depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale (CES-D20).
The CES-D20 has a total score ranging from 0 to 60 with a higher score indicating greater depressive symptoms.
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Baseline, 6 months
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Change in depressive symptoms as assessed by the GDS
Time Frame: Baseline, 6 months
|
Change in depressive symptoms will be measured using the Geriatric Depression Scale (GDS).
The GDS has a total score ranging from 0-15 with a higher score indicating higher depressive symptoms.
A score of 6 to 9 indicates suggestive depressive symptoms and a score of 10 to 15 indicates depressive symptoms.
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Baseline, 6 months
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Change in health care related habits
Time Frame: Baseline, 6 months
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Change in healthcare related habits is measured via the Health Care-Related Factors Questionnaire.
The total score ranges from 26 to 43 with a higher score indicating lesser health care related habits.
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Baseline, 6 months
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Change in technology use
Time Frame: Baseline, 6 months
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Change in technology use will be measured using a questionnaire assessing ability to use technology (pedometer, smartphones, apps, internet).
The total score ranges from 13-26 with a higher score indicating a lower ability to use technology.
|
Baseline, 6 months
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Change in knowledge regarding hypertension
Time Frame: Baseline, 6 months
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Change in knowledge regarding hypertension is measured using the Hypertension Survey.
The Hypertension Survey is a 10-item survey with a totals score ranging from 0-10 with a higher score indicating increased knowledge regarding hypertension.
|
Baseline, 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Rosina Cianelli, Ph.D., University of Miami
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 7, 2020
Primary Completion (Actual)
September 29, 2021
Study Completion (Actual)
September 29, 2021
Study Registration Dates
First Submitted
September 11, 2019
First Submitted That Met QC Criteria
September 11, 2019
First Posted (Actual)
September 13, 2019
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 12, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20190373
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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