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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03805516
Other study ID # 20429001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 16, 2019
Est. completion date August 31, 2021

Study information

Verified date November 2023
Source San Francisco State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project examines the feasibility of a smartphone-based intervention to reduce obesity and breast cancer risk among Chinese American women in San Francisco. The proposed intervention is to use the mobile application and an activity tracker device to promote a healthier lifestyle and physical activity. Ultimately, the findings will advance the NIH mission of enhancing health promotion and disease prevention.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
SCOPP-CW
The proposed intervention integrates the Social Cognitive Theory, use of everyday technology (WeChat), and an adaptation of an evidence-based program that is tailored to the behavior patterns, preferences, and cultures of premenopausal Chinese American women. The intervention includes three components: (1) daily tracking of physical activities, (2) 12 weekly educational modules on healthy lifestyle, physical activity, and breast cancer prevention, and (3) 6 bi-weekly tailored messages to include tips for lifestyle modification, stress management, and healthy weight maintenance based on the user's personal characteristics and behavior patterns.
Control
This is the comparative/control group for the intervention. The control group receives daily tracking of physical activity and 12 weekly non-tailored educational information on general health topics.

Locations

Country Name City State
United States San Francisco State University San Francisco California

Sponsors (2)

Lead Sponsor Collaborator
San Francisco State University University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Number of uses of the tracking app Weekly number of uses of the tracking app at 6 months
Other Frequency of accessing the 12 educational modules Weekly number of accessing the educational modules at 6 months
Primary waist circumference waist measured in centimeters by NIH waist circumference measurement protocol Change from baseline waist measurement at 3 months and 6 months
Primary breast cancer knowledge and attitudes 13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening Change from baseline breast cancer screening knowledge score at 3 months and 6 months
Secondary body mass index Weight and height (weight [kg]/height [m]) change from baseline BMI at 3 months and 6 months
Secondary self-efficacy 28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity Change from baseline self-efficacy questionnaire score at 3 months and 6 months
Secondary food intake Chinese food frequency questionnaire (FFQ) includes 118 food items Change from baseline food frequency at 3 months and 6 months
Secondary physical activity Daily tracking 10 hours awake time with a Fitbit device Change from baseline daily physical activity at 3 months and 6 months
Secondary blood pressure Systolic and diastolic blood pressure measured in mmHg Change from baseline blood pressure at 3 months and 6 months
Secondary Hemoglobin A1C Glycated hemoglobin to measure average level of blood sugar Change from baseline hemoglobin A1C at 6 months
Secondary Lipid panel A blood test that measures the level of different types of fat (lipid molecules) in the blood Change from baseline lipid panel at 6 months
Secondary C-reactive protein A blood test that measure the presence of inflammation in the body Change from baseline lipid panel at 6 months
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