Preventing Chronic Disease: ActuaYa

Not Applicable

Completed

• Conditions: Healthy Aging
• Interventions: Other: Go4Life-Physical Activity/Exercise Program "Workout to Go" 5; Behavioral: ActuaYa Educational Sessions

• Registration Number: NCT04088552
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-11
• Study First Posted: 2019-09-13
• Study Start: 2020-03-07
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-12
• Last Update Posted: 2021-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ActuaYa Arm	Go4Life-Physical Activity/Exercise Program "Workout to Go" 5	Participants will receive educational sessions, facilitated discussions and an exercise program.
ActuaYa Arm	ActuaYa Educational Sessions	Participants will receive educational sessions, facilitated discussions and an exercise program.

Primary Outcome Measures

Name	Time	Method
Change in mean Hemoglobin A1C (HbA1c) levels	Baseline, 6 months	HbA1c will be measured from finger stick blood sample.
Change in Blood Pressure	Baseline, 6 months	Changes in blood pressure will be measured using a manual sphygmomanometer by a registered nurse.
Change in active lifestyle as assessed by a self-report log	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.
Change in active lifestyle as assessed by the Exercise Survey	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.
Change in abdominal circumference	Baseline, 6 months	Measured using a measuring tape.
Change in Body Mass Index (BMI)	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.
Change in self-efficacy for condom use	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.
Change in active lifestyle as assessed by daily steps	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.
Change in nutritional habits	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.
Change in active lifestyle as assessed by the Exercise Question Survey	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.
Change in HIV risk behaviors	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.
Change in body fat composition	Baseline, 6 months	Measured using a bioelectrical impedance analysis.

Secondary Outcome Measures

Name	Time	Method
Change in depressive symptoms as assessed by the CES-D20	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.
Change in HIV risk perception	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.
Change in risk perception regarding obesity	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.
Change in HIV knowledge	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.
Change in depressive symptoms as assessed by the GDS	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.
Change in self-esteem	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.
Change in knowledge regarding obesity	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.
Change in knowledge regarding diabetes	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.
Change in technology use	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.
Change in health care related habits	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.
Change in knowledge regarding hypertension	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.

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States