Skip to content

Preventing Chronic Disease: ActuaYa

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04088552
Enrollment
50
Registered
2019-09-13
Start date
2020-03-07
Completion date
2021-09-29
Last updated
2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Aging

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.

Interventions

OTHERGo4Life-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.

BEHAVIORALActuaYa 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.

Sponsors

The Community Foundation of Broward
CollaboratorUNKNOWN
University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in abdominal circumferenceBaseline, 6 monthsMeasured using a measuring tape.
Change in mean Hemoglobin A1C (HbA1c) levelsBaseline, 6 monthsHbA1c will be measured from finger stick blood sample.
Change in Blood PressureBaseline, 6 monthsChanges in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.
Change in Body Mass Index (BMI)Baseline, 6 monthsBMI 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 useBaseline, 6 monthsMeasured 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 habitsBaseline, 6 monthsChange 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 stepsBaseline, 6 monthsChange 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 logBaseline, 6 monthsChange 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 SurveyBaseline, 6 monthsChange 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 SurveyBaseline, 6 monthsChange 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 behaviorsBaseline, 6 monthsChange 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 compositionBaseline, 6 monthsMeasured using a bioelectrical impedance analysis.

Secondary

MeasureTime frameDescription
Change in risk perception regarding obesityBaseline, 6 monthsChange 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 diabetesBaseline, 6 monthsChange 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 knowledgeBaseline, 6 monthsChange 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 perceptionBaseline, 6 monthsChange 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-esteemBaseline, 6 monthsChange 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-D20Baseline, 6 monthsChange 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 GDSBaseline, 6 monthsChange 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 habitsBaseline, 6 monthsChange 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 useBaseline, 6 monthsChange 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 hypertensionBaseline, 6 monthsChange 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.
Change in knowledge regarding obesityBaseline, 6 monthsChange 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026