Central Obesity and Cancer Prevention for Chinese American Women
Primary Purpose
Obesity, Abdominal, Cancer Prevention
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SCOPP-CW
Control
Sponsored by
About this trial
This is an interventional prevention trial for Obesity, Abdominal
Eligibility Criteria
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).
Sites / Locations
- San Francisco State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention
Control
Arm Description
. Daily use of a Fitbit Alta HRTM to identify behavior patterns. 12 weekly SCOPP-CW educational modules delivered via WeChat. 6 bi-weekly WeChat tailored messages based on based on the participant's tracker information, personal goals, and preferences
. Daily use of a Fitbit Alta HRTM to identify behavior patterns. 12 weekly non-tailored educational modules on general health topics delivered via WeChat.
Outcomes
Primary Outcome Measures
waist circumference
waist measured in centimeters by NIH waist circumference measurement protocol
breast cancer knowledge and attitudes
13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening
Secondary Outcome Measures
body mass index
Weight and height (weight [kg]/height [m])
self-efficacy
28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity
food intake
Chinese food frequency questionnaire (FFQ) includes 118 food items
physical activity
Daily tracking 10 hours awake time with a Fitbit device
blood pressure
Systolic and diastolic blood pressure measured in mmHg
Hemoglobin A1C
Glycated hemoglobin to measure average level of blood sugar
Lipid panel
A blood test that measures the level of different types of fat (lipid molecules) in the blood
C-reactive protein
A blood test that measure the presence of inflammation in the body
Full Information
NCT ID
NCT03805516
First Posted
January 9, 2019
Last Updated
May 1, 2020
Sponsor
San Francisco State University
Collaborators
University of California, San Francisco
1. Study Identification
Unique Protocol Identification Number
NCT03805516
Brief Title
Central Obesity and Cancer Prevention for Chinese American Women
Official Title
Central Obesity and Cancer Prevention for Chinese American Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 16, 2019 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
San Francisco State University
Collaborators
University of California, San Francisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Abdominal, Cancer Prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
. Daily use of a Fitbit Alta HRTM to identify behavior patterns.
12 weekly SCOPP-CW educational modules delivered via WeChat.
6 bi-weekly WeChat tailored messages based on based on the participant's tracker information, personal goals, and preferences
Arm Title
Control
Arm Type
Active Comparator
Arm Description
. Daily use of a Fitbit Alta HRTM to identify behavior patterns.
12 weekly non-tailored educational modules on general health topics delivered via WeChat.
Intervention Type
Behavioral
Intervention Name(s)
SCOPP-CW
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
waist circumference
Description
waist measured in centimeters by NIH waist circumference measurement protocol
Time Frame
Change from baseline waist measurement at 3 months and 6 months
Title
breast cancer knowledge and attitudes
Description
13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening
Time Frame
Change from baseline breast cancer screening knowledge score at 3 months and 6 months
Secondary Outcome Measure Information:
Title
body mass index
Description
Weight and height (weight [kg]/height [m])
Time Frame
change from baseline BMI at 3 months and 6 months
Title
self-efficacy
Description
28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity
Time Frame
Change from baseline self-efficacy questionnaire score at 3 months and 6 months
Title
food intake
Description
Chinese food frequency questionnaire (FFQ) includes 118 food items
Time Frame
Change from baseline food frequency at 3 months and 6 months
Title
physical activity
Description
Daily tracking 10 hours awake time with a Fitbit device
Time Frame
Change from baseline daily physical activity at 3 months and 6 months
Title
blood pressure
Description
Systolic and diastolic blood pressure measured in mmHg
Time Frame
Change from baseline blood pressure at 3 months and 6 months
Title
Hemoglobin A1C
Description
Glycated hemoglobin to measure average level of blood sugar
Time Frame
Change from baseline hemoglobin A1C at 6 months
Title
Lipid panel
Description
A blood test that measures the level of different types of fat (lipid molecules) in the blood
Time Frame
Change from baseline lipid panel at 6 months
Title
C-reactive protein
Description
A blood test that measure the presence of inflammation in the body
Time Frame
Change from baseline lipid panel at 6 months
Other Pre-specified Outcome Measures:
Title
Number of uses of the tracking app
Description
Weekly number of uses of the tracking app
Time Frame
at 6 months
Title
Frequency of accessing the 12 educational modules
Description
Weekly number of accessing the educational modules
Time Frame
at 6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-yu Chou, PhD
Phone
415-3386853
Email
fchou@sfsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jyu-Lin Chen, PhD
Phone
415-5026015
Email
Jyu-Lin.Chen@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang-yu Chou, PhD
Organizational Affiliation
San Francisco State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jyu-Lin Chen, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Francisco State University
City
San Francisco
State/Province
California
ZIP/Postal Code
94132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang-yu Chou, PhD
Phone
415-338-6853
Email
fchou@sfsu.edu
First Name & Middle Initial & Last Name & Degree
Jyu-Lin Chen, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Central Obesity and Cancer Prevention for Chinese American Women
We'll reach out to this number within 24 hrs