NCT05405803

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable depression

Timeline
4mo left

Started Dec 2022

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Dec 2022Oct 2026

First Submitted

Initial submission to the registry

June 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

December 12, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

September 12, 2025

Status Verified

September 1, 2025

Enrollment Period

3.8 years

First QC Date

June 1, 2022

Last Update Submit

September 7, 2025

Conditions

Keywords

DepressionKorean american women

Outcome Measures

Primary Outcomes (4)

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

    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.

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

  • Change in Acculturation Stress Scale (ASS)

    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.

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

  • Change in Social Readjustment Rating Scale (SRRS)

    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.

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

  • Change in Personal Resource Questionnaire (PRQ-2000)

    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.

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

Secondary Outcomes (7)

  • Change in Kaiser Physical Activity Survey (KPAS)

    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 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

  • +2 more secondary outcomes

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: Web-App based Lifestyle Physical Activity Promotion ProgramBehavioral: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines

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).

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

Interventions

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 sessions: information on 15 topics related to depressive symptoms and lifestyle physical activity. 3. Online Resources: include 20 links in English or Korean (only from scientific authorities including NIH, CDC,etc.). Weekly group coaching and support will start after the first 10 participants are enrolled, but individual coaching/support will start as soon as a participant enrolls.

Also known as: WPAPP-K
Intervention Group

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.

Control groupIntervention Group

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Centers for Disease Control and Prevention, U.S.

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

United States Public Health ServiceUnited States Dept. of Health and Human ServicesUnited States Government AgenciesFederal GovernmentGovernmentOrganizationsHealth Care Economics and Organizations

Study Officials

  • Eun-Ok Im, PhD, MPH

    The University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2022

First Posted

June 6, 2022

Study Start

December 12, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

September 12, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

When the research team decides to share the data with the researcher, the data in SPSS format, abstract, and original findings of the proposed study will be provided to the researcher. The data will have no identifying information to link a subject to her/his data.

Time Frame
After publishing the major paper from the complete data to 10 years from the completion of the study
Access Criteria
The researcher must request permission to conduct secondary analyses of the data from the PIs of the proposed study by e-mail or regular mail and provide the PIs with a 1-page long abstract (single-spaced) of the proposed analysis and her/his CV. When the research team decides to share the data with the researcher, the data in SPSS format, abstract, and original findings of the proposed study will be provided to the researcher. The researcher will be requested to: (a) agree that she/he will provide the findings from her/his analyses to the PIs at the completion of the analyses, (b) acknowledge the original study and the NIH in her/his future publications, and (c) not use the findings from the data for any commercial purposes. This agreement will be made in written form. The data will be provided to the researcher as a password-protected zipped file that needs to be downloaded through the Emory Box cloud service.

Locations