跳至主要内容
临床试验/NCT04088552
NCT04088552已完成不适用

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

University of Miami2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Change in mean Hemoglobin A1C (HbA1c) levels

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Change in mean Hemoglobin A1C (HbA1c) levels

时间窗: Baseline, 6 months

HbA1c will be measured from finger stick blood sample.

Change in Blood Pressure

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline, 6 months

Measured using a measuring tape.

Change in Body Mass Index (BMI)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: Baseline, 6 months

Measured using a bioelectrical impedance analysis.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosina Cianelli

Associate Professor

University of Miami

研究点 (2)

Loading locations...

相似试验