Back to resultsPreventing Chronic Disease: ActuaYa
Primary Purpose
Healthy Aging
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Go4Life-Physical Activity/Exercise Program "Workout to Go" 5
ActuaYa Educational Sessions
Sponsored by
About this trial
This is an interventional prevention trial for Healthy Aging
Eligibility Criteria
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.
Sites / Locations
- University of Miami
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ActuaYa Arm
Arm Description
Participants will receive educational sessions, facilitated discussions and an exercise program.
Outcomes
Primary Outcome Measures
Change in mean Hemoglobin A1C (HbA1c) levels
HbA1c will be measured from finger stick blood sample.
Change in Blood Pressure
Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.
Change in Body Mass Index (BMI)
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.
Change in self-efficacy for condom use
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.
Change in nutritional habits
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.
Change in active lifestyle as assessed by daily steps
Change in active lifestyle will be assessed by the amount of daily steps taken as assessed using a study provided wrist pedometer.
Change in active lifestyle as assessed by a self-report log
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.
Change in active lifestyle as assessed by the Exercise Survey
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.
Change in active lifestyle as assessed by the Exercise Question Survey
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.
Change in HIV risk behaviors
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.
Change in body fat composition
Measured using a bioelectrical impedance analysis.
Change in abdominal circumference
Measured using a measuring tape.
Secondary Outcome Measures
Change in knowledge regarding obesity
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.
Change in risk perception regarding obesity
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.
Change in knowledge regarding diabetes
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.
Change in HIV knowledge
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.
Change in HIV risk perception
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.
Change in self-esteem
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.
Change in depressive symptoms as assessed by the CES-D20
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.
Change in depressive symptoms as assessed by the GDS
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.
Change in health care related habits
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.
Change in technology use
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.
Change in knowledge regarding hypertension
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.
Full Information
NCT ID
NCT04088552
First Posted
September 11, 2019
Last Updated
October 12, 2021
Sponsor
University of Miami
Collaborators
The Community Foundation of Broward
1. Study Identification
Unique Protocol Identification Number
NCT04088552
Brief Title
Preventing Chronic Disease: ActuaYa
Official Title
Preventing Chronic Disease (HIV, Diabetes, Hypertension, Obesity) Among Older Hispanic Women in Broward
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2020 (Actual)
Primary Completion Date
September 29, 2021 (Actual)
Study Completion Date
September 29, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
The Community Foundation of Broward
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Aging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ActuaYa Arm
Arm Type
Experimental
Arm Description
Participants will receive educational sessions, facilitated discussions and an exercise program.
Intervention Type
Other
Intervention Name(s)
Go4Life-Physical Activity/Exercise Program "Workout to Go" 5
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
ActuaYa Educational Sessions
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in mean Hemoglobin A1C (HbA1c) levels
Description
HbA1c will be measured from finger stick blood sample.
Time Frame
Baseline, 6 months
Title
Change in Blood Pressure
Description
Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.
Time Frame
Baseline, 6 months
Title
Change in Body Mass Index (BMI)
Description
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.
Time Frame
Baseline, 6 months
Title
Change in self-efficacy for condom use
Description
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.
Time Frame
Baseline, 6 months
Title
Change in nutritional habits
Description
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.
Time Frame
Baseline, 6 months
Title
Change in active lifestyle as assessed by daily steps
Description
Change in active lifestyle will be assessed by the amount of daily steps taken as assessed using a study provided wrist pedometer.
Time Frame
Baseline, 6 months
Title
Change in active lifestyle as assessed by a self-report log
Description
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.
Time Frame
Baseline, 6 months
Title
Change in active lifestyle as assessed by the Exercise Survey
Description
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.
Time Frame
Baseline, 6 months
Title
Change in active lifestyle as assessed by the Exercise Question Survey
Description
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.
Time Frame
Baseline, 6 months
Title
Change in HIV risk behaviors
Description
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.
Time Frame
Baseline, 6 months
Title
Change in body fat composition
Description
Measured using a bioelectrical impedance analysis.
Time Frame
Baseline, 6 months
Title
Change in abdominal circumference
Description
Measured using a measuring tape.
Time Frame
Baseline, 6 months
Secondary Outcome Measure Information:
Title
Change in knowledge regarding obesity
Description
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.
Time Frame
Baseline, 6 months
Title
Change in risk perception regarding obesity
Description
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.
Time Frame
Baseline, 6 months
Title
Change in knowledge regarding diabetes
Description
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.
Time Frame
Baseline, 6 months
Title
Change in HIV knowledge
Description
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.
Time Frame
Baseline, 6 months
Title
Change in HIV risk perception
Description
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.
Time Frame
Baseline, 6 months
Title
Change in self-esteem
Description
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.
Time Frame
Baseline, 6 months
Title
Change in depressive symptoms as assessed by the CES-D20
Description
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.
Time Frame
Baseline, 6 months
Title
Change in depressive symptoms as assessed by the GDS
Description
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.
Time Frame
Baseline, 6 months
Title
Change in health care related habits
Description
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.
Time Frame
Baseline, 6 months
Title
Change in technology use
Description
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.
Time Frame
Baseline, 6 months
Title
Change in knowledge regarding hypertension
Description
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.
Time Frame
Baseline, 6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosina Cianelli, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33146
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preventing Chronic Disease: ActuaYa
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