To Improve Depressive Symptoms Using a Web-App

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Поведенческое Web-App based Lifestyle Physical Activity Promotion Program
  WPAPP-K includes group and individual coaching/support by health care providers, peer coaching/support, and information to change the women's attitudes, self-efficacy, perceived barriers, and social influences. The program includes 3 components in 2 languages (English and Korean): 1. Social media sites: allow participants to share their experiences and to receive individual and group coaching/ support from culturally matched peers and healthcare providers. 2. Interactive online educational ses
• Поведенческое The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines
  A link to the CDC website will be provided through the project website, and participants will be asked to use it during the study period (12 months). Their use of the CDC website will be automatically measured through the project website.

Первичные конечные точки

• Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K) [Срок оценки: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention (T2)]
• Change in Acculturation Stress Scale (ASS) [Срок оценки: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention]
• Change in Social Readjustment Rating Scale (SRRS) [Срок оценки: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention]
• Change in Personal Resource Questionnaire (PRQ-2000) [Срок оценки: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention]

Вторичные конечные точки (7)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The University of Texas at Austin — Austin

Идентификаторы

NCT: NCT05405803 · STUDY00004809 · 1R01NR020334-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗