To Improve Depressive Symptoms Using a Web-App
- Conditions
- Depression
- Interventions
- Behavioral: Web-App based Lifestyle Physical Activity Promotion ProgramBehavioral: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines
- Registration Number
- NCT05405803
- Lead Sponsor
- University of Texas at Austin
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 300
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Web-App based Lifestyle Physical Activity Promotion Program Participants will be asked to visit WPAPP-K at least two times a week for 12 months. Control group The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines Participants will have access to a link of the CDC website from baseline and during the duration of the study (12 months). Intervention Group The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines Participants will be asked to visit WPAPP-K at least two times a week for 12 months.
- Primary Outcome Measures
Name Time Method Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K) 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) 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) 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) 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.
- Secondary Outcome Measures
Name Time Method Change in time of exercise using Fitbit Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention Lifestyle physical activity score using Fitbit, measuring time of exercise.
Change in exercise intensity during using Fitbit Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention Lifestyle physical activity score using Fitbit, measuring type of exercise intensity (low, medium, or high intensity). Higher intensity correlates with better outcome.
Change in resting heart rate using Fitbit Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention Fitbit wil record continuous, automatic, wrist-based resting heart rates.
Change in total number of steps using Fitbit Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention Lifestyle physical activity score using Fitbit, measuring number of steps.
Change in Kaiser Physical Activity Survey (KPAS) Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention The KPAS is a self-report measure regarding physical activity and living habits. Survey consists of 38 items; 4 domains: household and family care activities, occupational activities, active living habits, participation in sports/ exercise. Activity indices were created for each domain of activity by summing the domain-specific categorical responses and dividing by the number of items, giving an average value that ranged from 1 to 5. Total activity index is calculated as the sum of all four indices: Total activity = (household/caregiving index\*0.25 + occupational index\*0.25 + active living index\*0.25 + sports/exercise index\*0.25) \* 4.
Change in BMI from baseline Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention 2 questions on body weight and height to measure BMI (BMI calculated in kg/m).
Change in waist circumference Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention The participants will measure their waist circumferences to the nearest cm at the narrowest part of the torso above the umbilicus and below the xiphoid using the paper rulers that will be mailed to them.136 Information with pictures on how to correctly measure and assistance by phone and/or Webcam will be provided.
Trial Locations
- Locations (1)
The University of Texas at Austin
🇺🇸Austin, Texas, United States