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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

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.

Condition or disease Intervention/treatment Phase
Obesity, Abdominal Cancer Prevention Behavioral: SCOPP-CW Behavioral: Control Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Central Obesity and Cancer Prevention for Chinese American Women
Actual Study Start Date : October 16, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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
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.

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.
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.




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. body mass index [ Time Frame: change from baseline BMI at 3 months and 6 months ]
    Weight and height (weight [kg]/height [m])

  2. 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

  3. food intake [ Time Frame: Change from baseline food frequency at 3 months and 6 months ]
    Chinese food frequency questionnaire (FFQ) includes 118 food items

  4. 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

  5. blood pressure [ Time Frame: Change from baseline blood pressure at 3 months and 6 months ]
    Systolic and diastolic blood pressure measured in mmHg

  6. Hemoglobin A1C [ Time Frame: Change from baseline hemoglobin A1C at 6 months ]
    Glycated hemoglobin to measure average level of blood sugar

  7. 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

  8. 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


Other Outcome Measures:
  1. Number of uses of the tracking app [ Time Frame: at 6 months ]
    Weekly number of uses of the tracking app

  2. Frequency of accessing the 12 educational modules [ Time Frame: at 6 months ]
    Weekly number of accessing the educational modules



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03805516


Contacts
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Contact: Fang-yu Chou, PhD 415-3386853 fchou@sfsu.edu
Contact: Jyu-Lin Chen, PhD 415-5026015 Jyu-Lin.Chen@ucsf.edu

Locations
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United States, California
San Francisco State University Recruiting
San Francisco, California, United States, 94132
Contact: Fang-yu Chou, PhD    415-338-6853    fchou@sfsu.edu   
Sub-Investigator: Jyu-Lin Chen, PhD         
Sponsors and Collaborators
San Francisco State University
University of California, San Francisco
Investigators
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Principal Investigator: Fang-yu Chou, PhD San Francisco State University
Principal Investigator: Jyu-Lin Chen, PhD University of California, San Francisco
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Responsible Party: San Francisco State University
ClinicalTrials.gov Identifier: NCT03805516    
Other Study ID Numbers: 20429001
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight