To Improve Depressive Symptoms Using a Web-App

Sponsor
Emory University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05405803
Collaborator
(none)
300
1
2
48
6.3

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Web-App based Lifestyle Physical Activity Promotion Program
  • Behavioral: The Centers for Disease Control and Prevention (CDC) website on depression and physical activity guidelines
N/A

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
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Web-App Based Lifestyle Physical Activity Promotion Program to Improve Depressive Symptom Experience: Midlife Korean American Women
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Oct 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

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 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): Social media sites: allow participants to share their experiences and to receive individual and group coaching/ support from culturally matched peers and healthcare providers. Interactive online educational sessions: information on 15 topics related to depressive symptoms and lifestyle physical activity. 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.
Other Names:
  • WPAPP-K
  • Behavioral: 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.

    Active Comparator: Control group

    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
    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.

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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).

    7. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 60 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Emory University Hospital Atlanta Georgia United States 30322

    Sponsors and Collaborators

    • Emory University

    Investigators

    • Principal Investigator: Eun-Ok Im, PhD, MPH, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eun-Ok Im, Professor, Emory University
    ClinicalTrials.gov Identifier:
    NCT05405803
    Other Study ID Numbers:
    • STUDY00003648
    First Posted:
    Jun 6, 2022
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eun-Ok Im, Professor, Emory University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2022