Preventing Chronic Disease: ActuaYa

NCT04088552 | Completed

• 1 other identifier: 20190373
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (12)

• Change in mean Hemoglobin A1C (HbA1c) levels

  HbA1c will be measured from finger stick blood sample.

  Baseline, 6 months

• Change in Blood Pressure

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

  Baseline, 6 months

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• Change in body fat composition

  Measured using a bioelectrical impedance analysis.

  Baseline, 6 months

• Change in abdominal circumference

  Measured using a measuring tape.

  Baseline, 6 months

Secondary Outcomes (11)

• Change in knowledge regarding obesity

  Baseline, 6 months

• Change in risk perception regarding obesity

  Baseline, 6 months

• Change in knowledge regarding diabetes

  Baseline, 6 months

• Change in HIV knowledge

  Baseline, 6 months

• Change in HIV risk perception

  Baseline, 6 months

Study Arms (1)

ActuaYa Arm

EXPERIMENTAL

Participants will receive educational sessions, facilitated discussions and an exercise program.

Other: Go4Life-Physical Activity/Exercise Program "Workout to Go" 5; Behavioral: ActuaYa Educational Sessions

Interventions

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 Arm

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.

ActuaYa Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• The Community Foundation of Broward: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33146, United States

Location

Study Officials

• Rosina Cianelli, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 13, 2019
• Study Start: March 7, 2020
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)