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Clinical Trials/NCT05405803
NCT05405803RecruitingNot Applicable

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

University of Texas at Austin1 site in 1 country300 target enrollmentStarted: December 12, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
1
Primary Endpoint
Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 60 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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

Arms & Interventions

Intervention Group

Experimental

Participants will be asked to visit WPAPP-K at least two times a week for 12 months.

Intervention: Web-App based Lifestyle Physical Activity Promotion Program (Behavioral)

Intervention Group

Experimental

Participants will be asked to visit WPAPP-K at least two times a week for 12 months.

Intervention: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines (Behavioral)

Control group

Active Comparator

Participants will have access to a link of the CDC website from baseline and during the duration of the study (12 months).

Intervention: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines (Behavioral)

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • 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)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eun-Ok Im

Professor

University of Texas at Austin

Study Sites (1)

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