Clinical trial NCT05405803: To Improve Depressive Symptoms Using a Web-App
Official title: A Web-App Based Lifestyle Physical Activity Promotion Program to Improve Depressive Symptom Experience: Midlife Korean American Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Depression
Korean american women
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2022-06-06
Enrollment: 300
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Center for Epidemiologic Studies Depression Scale-Korean (CESD-K)
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention (T2)
measure: Change in Acculturation Stress Scale (ASS)
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in Social Readjustment Rating Scale (SRRS)
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in Personal Resource Questionnaire (PRQ-2000)
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Secondary outcomes:
measure: Change in Kaiser Physical Activity Survey (KPAS)
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in total number of steps using Fitbit
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in time of exercise using Fitbit
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in exercise intensity during using Fitbit
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in resting heart rate using Fitbit
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in BMI from baseline
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
measure: Change in waist circumference
timeFrame: Baseline(T0), 6-months post-intervention (T1), and post 12-months post-intervention
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: The University of Texas at Austin
name: Eun-Ok Im, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: