Preventing Chronic Disease: ActuaYa

Healthy Aging Clinical Trial

Official title:

Preventing Chronic Disease (HIV, Diabetes, Hypertension, Obesity) Among Older Hispanic Women in Broward

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04088552
• Other study ID #: 20190373
• Status: Completed
• Phase: N/A
• Start date: March 7, 2020
• Est. completion date: September 29, 2021

Study information

• Verified date: October 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 29, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years and older

Eligibility

Inclusion Criteria

1. Must self-identify as a Hispanic woman

2. Must be aged 50 years or older

3. Must not already be engaging in exercise for >150 minutes per week

4. Must be able to ambulate without the use of assistive devices

5. Must have an intelligent phone iOS or Android

6. Must be willing and able to participate in the informed consent process.

Exclusion Criteria

1. Participants that do not meet the above-mentioned criteria.

2. In the opinion of the investigator, have any clinical condition that would make the participant unsuitable to participate.

3. Participants who are currently participating in another investigational study.

4. Participants that need a medical clearance for exercise based on the American College of Sports Medicine exercise participation algorithm.

Related Conditions & MeSH terms

• Chronic Disease
• Healthy Aging

Intervention

Other:
• Go4Life-Physical Activity/Exercise Program "Workout to Go" 5
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.

Behavioral:
• ActuaYa Educational Sessions
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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	The Community Foundation of Broward

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in mean Hemoglobin A1C (HbA1c) levels	HbA1c will be measured from finger stick blood sample.	Baseline, 6 months
Primary	Change in Blood Pressure	Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	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.	Baseline, 6 months
Primary	Change in body fat composition	Measured using a bioelectrical impedance analysis.	Baseline, 6 months
Primary	Change in abdominal circumference	Measured using a measuring tape.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months
Secondary	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.	Baseline, 6 months