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Central Obesity and Cancer Prevention for Chinese American Women

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ClinicalTrials.gov Identifier: NCT03805516
Recruitment Status : Recruiting
First Posted : January 15, 2019
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
San Francisco State University

Tracking Information
First Submitted Date  ICMJE January 9, 2019
First Posted Date  ICMJE January 15, 2019
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE October 16, 2019
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 1, 2020)
  • body mass index [ Time Frame: change from baseline BMI at 3 months and 6 months ]
    Weight and height (weight [kg]/height [m])
  • self-efficacy [ Time Frame: Change from baseline self-efficacy questionnaire score at 3 months and 6 months ]
    28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity
  • food intake [ Time Frame: Change from baseline food frequency at 3 months and 6 months ]
    Chinese food frequency questionnaire (FFQ) includes 118 food items
  • 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
  • blood pressure [ Time Frame: Change from baseline blood pressure at 3 months and 6 months ]
    Systolic and diastolic blood pressure measured in mmHg
  • Hemoglobin A1C [ Time Frame: Change from baseline hemoglobin A1C at 6 months ]
    Glycated hemoglobin to measure average level of blood sugar
  • Lipid panel [ Time Frame: Change from baseline lipid panel at 6 months ]
    A blood test that measures the level of different types of fat (lipid molecules) in the blood
  • C-reactive protein [ Time Frame: Change from baseline lipid panel at 6 months ]
    A blood test that measure the presence of inflammation in the body
Original Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • body mass index [ Time Frame: change from baseline BMI at 3 months and 6 months ]
    Weight and height (weight [kg]/height [m])
  • self-efficacy [ Time Frame: Change from baseline self-efficacy questionnaire score at 3 months and 6 months ]
    28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity
  • food intake [ Time Frame: Change from baseline food frequency at 3 months and 6 months ]
    Chinese food frequency questionnaire (FFQ) includes 118 food items
  • 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
  • blood pressure [ Time Frame: Change from baseline blood pressure at 3 months and 6 months ]
    Systolic and diastolic blood pressure measured in mmHg
  • Hemoglobin A1C [ Time Frame: Change from baseline hemoglobin A1C at 6 months ]
    Glycated hemoglobin to measure average level of blood sugar
  • Lipid panel [ Time Frame: Change from baseline lipid panel at 6 months ]
    A blood test that measures the level of different types of fat (lipid molecules) in the blood
Current Other Pre-specified Outcome Measures
 (submitted: January 14, 2019)
  • Number of uses of the tracking app [ Time Frame: at 6 months ]
    Weekly number of uses of the tracking app
  • Frequency of accessing the 12 educational modules [ Time Frame: at 6 months ]
    Weekly number of accessing the educational modules
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Central Obesity and Cancer Prevention for Chinese American Women
Official Title  ICMJE Central Obesity and Cancer Prevention for Chinese American Women
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity, Abdominal
  • Cancer Prevention
Intervention  ICMJE
  • 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.
  • Behavioral: 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.
Study Arms  ICMJE
  • Experimental: Intervention
    1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns.
    2. 12 weekly SCOPP-CW educational modules delivered via WeChat.
    3. 6 bi-weekly WeChat tailored messages based on based on the participant's tracker information, personal goals, and preferences
    Intervention: Behavioral: SCOPP-CW
  • Active Comparator: Control
    1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns.
    2. 12 weekly non-tailored educational modules on general health topics delivered via WeChat.
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date October 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Fang-yu Chou, PhD 415-3386853 fchou@sfsu.edu
Contact: Jyu-Lin Chen, PhD 415-5026015 Jyu-Lin.Chen@ucsf.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03805516
Other Study ID Numbers  ICMJE 20429001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party San Francisco State University
Study Sponsor  ICMJE San Francisco State University
Collaborators  ICMJE University of California, San Francisco
Investigators  ICMJE
Principal Investigator: Fang-yu Chou, PhD San Francisco State University
Principal Investigator: Jyu-Lin Chen, PhD University of California, San Francisco
PRS Account San Francisco State University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP