Clinical trial NCT04088552: Preventing Chronic Disease: ActuaYa
Official title: Preventing Chronic Disease (HIV, Diabetes, Hypertension, Obesity) Among Older Hispanic Women in Broward
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: The Community Foundation of Broward
First posted: 2019-09-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean Hemoglobin A1C (HbA1c) levels
timeFrame: Baseline, 6 months
measure: Change in Blood Pressure
timeFrame: Baseline, 6 months
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline, 6 months
measure: Change in self-efficacy for condom use
timeFrame: Baseline, 6 months
measure: Change in nutritional habits
timeFrame: Baseline, 6 months
measure: Change in active lifestyle as assessed by daily steps
timeFrame: Baseline, 6 months
measure: Change in active lifestyle as assessed by a self-report log
timeFrame: Baseline, 6 months
measure: Change in active lifestyle as assessed by the Exercise Survey
timeFrame: Baseline, 6 months
measure: Change in active lifestyle as assessed by the Exercise Question Survey
timeFrame: Baseline, 6 months
measure: Change in HIV risk behaviors
timeFrame: Baseline, 6 months
measure: Change in body fat composition
timeFrame: Baseline, 6 months
measure: Change in abdominal circumference
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Change in knowledge regarding obesity
timeFrame: Baseline, 6 months
measure: Change in risk perception regarding obesity
timeFrame: Baseline, 6 months
measure: Change in knowledge regarding diabetes
timeFrame: Baseline, 6 months
measure: Change in HIV knowledge
timeFrame: Baseline, 6 months
measure: Change in HIV risk perception
timeFrame: Baseline, 6 months
measure: Change in self-esteem
timeFrame: Baseline, 6 months
measure: Change in depressive symptoms as assessed by the CES-D20
timeFrame: Baseline, 6 months
measure: Change in depressive symptoms as assessed by the GDS
timeFrame: Baseline, 6 months
measure: Change in health care related habits
timeFrame: Baseline, 6 months
measure: Change in technology use
timeFrame: Baseline, 6 months
measure: Change in knowledge regarding hypertension
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Rosina Cianelli, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: