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Clinical Trials/NCT04088552
NCT04088552
Completed
Not Applicable

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

University of Miami1 site in 1 country50 target enrollmentMarch 7, 2020
ConditionsHealthy Aging

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy Aging
Sponsor
University of Miami
Enrollment
50
Locations
1
Primary Endpoint
Change in mean Hemoglobin A1C (HbA1c) levels
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 7, 2020
End Date
September 29, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Rosina Cianelli

Associate Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in mean Hemoglobin A1C (HbA1c) levels

Time Frame: Baseline, 6 months

HbA1c will be measured from finger stick blood sample.

Change in Blood Pressure

Time Frame: 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

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.

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.

Change in abdominal circumference

Time Frame: Baseline, 6 months

Measured using a measuring tape.

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.

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.

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.

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.

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.

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.

Change in body fat composition

Time Frame: Baseline, 6 months

Measured using a bioelectrical impedance analysis.

Secondary Outcomes

  • Change in depressive symptoms as assessed by the CES-D20(Baseline, 6 months)
  • Change in HIV risk perception(Baseline, 6 months)
  • Change in risk perception regarding obesity(Baseline, 6 months)
  • Change in HIV knowledge(Baseline, 6 months)
  • Change in depressive symptoms as assessed by the GDS(Baseline, 6 months)
  • Change in self-esteem(Baseline, 6 months)
  • Change in knowledge regarding obesity(Baseline, 6 months)
  • Change in knowledge regarding diabetes(Baseline, 6 months)
  • Change in technology use(Baseline, 6 months)
  • Change in health care related habits(Baseline, 6 months)
  • Change in knowledge regarding hypertension(Baseline, 6 months)

Study Sites (1)

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