Skip to main content
OpenTrials
Completed

NCT Number: NCT04088552

Preventing Chronic Disease: ActuaYa

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy Aging

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Go4Life-Physical Activity/Exercise Program "Workout to Go" 5

Other

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.

ActuaYa Educational Sessions

Behavioral

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 outcomes

  1. Change in mean Hemoglobin A1C (HbA1c) levels

    Time frame: Baseline, 6 months

    HbA1c will be measured from finger stick blood sample.

  2. Change in Blood Pressure

    Time frame: Baseline, 6 months

    Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.

  3. 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.

  4. 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.

  5. 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.

  6. Change in active lifestyle as assessed by daily steps

    Time frame: Baseline, 6 months

    Change in active lifestyle will be assessed by the amount of daily steps taken as assessed using a study provided wrist pedometer.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. Change in body fat composition

    Time frame: Baseline, 6 months

    Measured using a bioelectrical impedance analysis.

  12. Change in abdominal circumference

    Time frame: Baseline, 6 months

    Measured using a measuring tape.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Change in self-esteem

    Time frame: Baseline, 6 months

    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.

  7. Change in depressive symptoms as assessed by the CES-D20

    Time frame: Baseline, 6 months

    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.

  8. 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.

  9. Change in health care related habits

    Time frame: Baseline, 6 months

    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.

  10. Change in technology use

    Time frame: Baseline, 6 months

    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.

  11. Change in knowledge regarding hypertension

    Time frame: Baseline, 6 months

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • The Community Foundation of Broward

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 13, 2019
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.