- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03805516
Central Obesity and Cancer Prevention for Chinese American Women
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Cancer is the leading cause of death in women in the United States (US). Chinese Americans are the largest ethnic group among Asian Americans. Although the incidence of breast cancer, the most common cancer in women, has decreased among other U.S racial groups over the last 15 years, Chinese American women in California have experienced a significant increase of incidence of 1.1% from 1998 to 2013. Studies have found that assimilation stress and obesity are associated with increased risk for breast cancer in Chinese American women. There are no existing interventions targeted at breast cancer prevention among premenopausal mothers with abdominal obesity. Interventions tailored to an individual's cultural, lifestyle and social support system are needed to reduce obesity and breast cancer risk. A smartphone-based intervention provides a promising platform for obesity and cancer prevention. The overall goal of this project is to test the feasibility of an obesity and breast cancer prevention intervention among Chinese American women in San Francisco. The investigators will adapt the Healthy Mothers Healthy Children: Technology-Based Intervention to Prevent Obesity to reduce obesity and breast cancer risk in premenopausal women with abdominal obesity who have dependent children in San Francisco. The proposed intervention ("Smartphone-Based Cancer and Obesity Prevention Program for Chinese Women: SCOPP-CW) includes 12 weekly educational modules and six bi-weekly tailored messages delivered via WeChat, a popular private communication app used by Chinese and Chinese Americans. The investigators propose to conduct a pilot randomized control study (RCT) to assess the short-term efficacy of SCOPP-CW on abdominal obesity, breast cancer knowledge and attitudes, weight-related behaviors (food intake and physical activity), and metabolic risk (blood pressure, lipid profile, hemoglobin A1c), which are associated with breast cancer. Thus the investigators propose the following aims: (1) Aim 1: To estimate the preliminary efficacy of the SCOPP-CW intervention on the primary outcomes (i.e. waist circumference and breast cancer knowledge and attitudes) and secondary outcomes (i.e. body mass index, self-efficacy, food intake, physical activity at baseline, 3 months, and 6 months, and metabolic risk [blood pressure, hemoglobin A1C, and lipid panel]) at baseline and 6 months.
Aim 2: To assess feasibility by understanding participants' acceptance, barriers to adherence and recommendations for intervention using focus group interviews. The investigators anticipate that this intervention will have a significant impact on breast cancer prevention. The investigators plan to use the proposed pilot study's findings to conduct a larger scale randomized trial (R01) to test the long-term efficacy of the intervention.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fang-yu Chou, PhD
- Phone Number: 415-3386853
- Email: fchou@sfsu.edu
Study Contact Backup
- Name: Jyu-Lin Chen, PhD
- Phone Number: 415-5026015
- Email: Jyu-Lin.Chen@ucsf.edu
Study Locations
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-
California
-
San Francisco, California, United States, 94132
- San Francisco State University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- be female
- be at least 18 years old
- have a waist circumference great than 80 cm
- own a smartphone
- be able to read Chinese and speak Mandarin
- be premenopausal
- have a child between the age of 1 and 18 years old.
Exclusion Criteria:
- are pregnant
- gave birth less than 12 months prior to enrollment date
- have a history of breast cancer
- have an acute or life-threatening disease (e.g., renal failure).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
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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.
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Active Comparator: Control
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
waist circumference
Time Frame: Change from baseline waist measurement at 3 months and 6 months
|
waist measured in centimeters by NIH waist circumference measurement protocol
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Change from baseline waist measurement at 3 months and 6 months
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breast cancer knowledge and attitudes
Time Frame: Change from baseline breast cancer screening knowledge score at 3 months and 6 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
body mass index
Time Frame: change from baseline BMI at 3 months and 6 months
|
Weight and height (weight [kg]/height [m])
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change from baseline BMI at 3 months and 6 months
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self-efficacy
Time Frame: Change from baseline self-efficacy questionnaire score at 3 months and 6 months
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28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity
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Change from baseline self-efficacy questionnaire score at 3 months and 6 months
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food intake
Time Frame: Change from baseline food frequency at 3 months and 6 months
|
Chinese food frequency questionnaire (FFQ) includes 118 food items
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Change from baseline food frequency at 3 months and 6 months
|
physical activity
Time Frame: Change from baseline daily physical activity at 3 months and 6 months
|
Daily tracking 10 hours awake time with a Fitbit device
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Change from baseline daily physical activity at 3 months and 6 months
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blood pressure
Time Frame: Change from baseline blood pressure at 3 months and 6 months
|
Systolic and diastolic blood pressure measured in mmHg
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Change from baseline blood pressure at 3 months and 6 months
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Hemoglobin A1C
Time Frame: Change from baseline hemoglobin A1C at 6 months
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Glycated hemoglobin to measure average level of blood sugar
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Change from baseline hemoglobin A1C at 6 months
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Lipid panel
Time Frame: Change from baseline lipid panel at 6 months
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A blood test that measures the level of different types of fat (lipid molecules) in the blood
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Change from baseline lipid panel at 6 months
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C-reactive protein
Time Frame: Change from baseline lipid panel at 6 months
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A blood test that measure the presence of inflammation in the body
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Change from baseline lipid panel at 6 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of uses of the tracking app
Time Frame: at 6 months
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Weekly number of uses of the tracking app
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at 6 months
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Frequency of accessing the 12 educational modules
Time Frame: at 6 months
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Weekly number of accessing the educational modules
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at 6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jyu-Lin Chen, PhD, University of California, San Francisco
- Principal Investigator: Fang-yu Chou, PhD, San Francisco State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20429001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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