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临床试验/NCT05405803
NCT05405803招募中不适用

A Web-App Based Lifestyle Physical Activity Promotion Program to Improve Depressive Symptom Experience: Midlife Korean American Women

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
2
主要终点
Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)

研究概览

简要总结

This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K).

详细描述

This study is being done to answer a question on whether a Web App-based Lifestyle Physical Activity Promotion Program is effective in improving depressive symptom experience of midlife Korean American women (WPAPP-K). Korean American midlife women tend to suffer from depressive symptoms due to their menopausal transition, cultural background, age, and gender. The WPAPP-K program that the investigators are testing is designed to help Korean American midlife women by providing information and coaching/support to increase lifestyle physical activity and subsequently improve their depressive symptom experience during the menopausal transition. The research team wants to know if the program improves depressive symptom experience of Korean American midlife women as designed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • self-reported midlife Korean-American women
  • aged 40 to 60 years
  • whose parents and grandparents are of Korean descent;
  • who can read and write English or Korean;
  • who currently reside in the United States;
  • who are sedentary (without any disabilities preventing physical activity);
  • who are online through computers or mobile devices;
  • have experienced depressive symptoms during the past two weeks (1 to 10 on the Patient Health Questionnaire [PHQ-9],which is equivalent to the cut-point of minimal to moderate depression.

排除标准

  • major signs or symptoms suggestive of pulmonary or CVD
  • history of a myocardial infarction, stroke, or Type I diabetes mellitus
  • blood pressure higher than 160/100 mm Hg
  • Use of beta-blockers, diltiazem, or verapamil

结局指标

主要结局

Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)

时间窗: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention (T2)

The Center for Epidemiologic Studies Depression Scale-Korean (CESD-K) measures the frequency of depressive symptoms in the past week. It includes 20 items on the level of depression (range=0\~60). 21 as a cutoff score, indicating presence of depressive symptoms, because Koreans give negative responses for positive effects. High scores indicating greater depressive symptoms. A lower score correlates with better outcome.

Change in Acculturation Stress Scale (ASS)

时间窗: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention

12 questions to assess the magnitude of stress associated with acculturation process (e.g., language difficulties, economic and social conflicts). Each with 4-point Likert scale (0=not stressful to 3=very stressful). Total possible score 0-36 with higher score correlating with worse outcome.

Change in Social Readjustment Rating Scale (SRRS)

时间窗: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention

57 items on life events (e.g., death, marriage, empty nest, etc.), giving different weighting depending on the severity of the stressor (possible total score 0 to 100). Higher score correlates with higher stress.

Change in Personal Resource Questionnaire (PRQ-2000)

时间窗: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention

15 7-point Likert scale items measuring perceived level of social support. 5 dimensions: (a) provision for attachment/intimacy; (b) social integration; (c) opportunity for nurturing behavior; (d) reassurance of worth; and (e) the availability of informational, emotional, and material helps. Total possible score range: 15 to 105. Higher scores indicating more support; higher scores are better outcomes.

次要结局

  • Change in time of exercise using Fitbit(Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention)
  • Change in exercise intensity during using Fitbit(Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention)
  • Change in resting heart rate using Fitbit(Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention)
  • Change in total number of steps using Fitbit(Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention)
  • Change in Kaiser Physical Activity Survey (KPAS)(Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention)
  • Change in BMI from baseline(Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention)
  • Change in waist circumference(Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention)

研究者

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

Eun-Ok Im

Professor

University of Texas at Austin

研究点 (2)

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