<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03805516</url>
  </required_header>
  <id_info>
    <org_study_id>20429001</org_study_id>
    <nct_id>NCT03805516</nct_id>
  </id_info>
  <brief_title>Central Obesity and Cancer Prevention for Chinese American Women</brief_title>
  <official_title>Central Obesity and Cancer Prevention for Chinese American Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>San Francisco State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>San Francisco State University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project examines the feasibility of a smartphone-based intervention to reduce obesity&#xD;
      and breast cancer risk among Chinese American women in San Francisco. The proposed&#xD;
      intervention is to use the mobile application and an activity tracker device to promote a&#xD;
      healthier lifestyle and physical activity. Ultimately, the findings will advance the NIH&#xD;
      mission of enhancing health promotion and disease prevention.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cancer is the leading cause of death in women in the United States (US). Chinese Americans&#xD;
      are the largest ethnic group among Asian Americans. Although the incidence of breast cancer,&#xD;
      the most common cancer in women, has decreased among other U.S racial groups over the last 15&#xD;
      years, Chinese American women in California have experienced a significant increase of&#xD;
      incidence of 1.1% from 1998 to 2013. Studies have found that assimilation stress and obesity&#xD;
      are associated with increased risk for breast cancer in Chinese American women. There are no&#xD;
      existing interventions targeted at breast cancer prevention among premenopausal mothers with&#xD;
      abdominal obesity. Interventions tailored to an individual's cultural, lifestyle and social&#xD;
      support system are needed to reduce obesity and breast cancer risk. A smartphone-based&#xD;
      intervention provides a promising platform for obesity and cancer prevention. The overall&#xD;
      goal of this project is to test the feasibility of an obesity and breast cancer prevention&#xD;
      intervention among Chinese American women in San Francisco. The investigators will adapt the&#xD;
      Healthy Mothers Healthy Children: Technology-Based Intervention to Prevent Obesity to reduce&#xD;
      obesity and breast cancer risk in premenopausal women with abdominal obesity who have&#xD;
      dependent children in San Francisco. The proposed intervention (&quot;Smartphone-Based Cancer and&#xD;
      Obesity Prevention Program for Chinese Women: SCOPP-CW) includes 12 weekly educational&#xD;
      modules and six bi-weekly tailored messages delivered via WeChat, a popular private&#xD;
      communication app used by Chinese and Chinese Americans. The investigators propose to conduct&#xD;
      a pilot randomized control study (RCT) to assess the short-term efficacy of SCOPP-CW on&#xD;
      abdominal obesity, breast cancer knowledge and attitudes, weight-related behaviors (food&#xD;
      intake and physical activity), and metabolic risk (blood pressure, lipid profile, hemoglobin&#xD;
      A1c), which are associated with breast cancer. Thus the investigators propose the following&#xD;
      aims: (1) Aim 1: To estimate the preliminary efficacy of the SCOPP-CW intervention on the&#xD;
      primary outcomes (i.e. waist circumference and breast cancer knowledge and attitudes) and&#xD;
      secondary outcomes (i.e. body mass index, self-efficacy, food intake, physical activity at&#xD;
      baseline, 3 months, and 6 months, and metabolic risk [blood pressure, hemoglobin A1C, and&#xD;
      lipid panel]) at baseline and 6 months.&#xD;
&#xD;
      Aim 2: To assess feasibility by understanding participants' acceptance, barriers to adherence&#xD;
      and recommendations for intervention using focus group interviews. The investigators&#xD;
      anticipate that this intervention will have a significant impact on breast cancer prevention.&#xD;
      The investigators plan to use the proposed pilot study's findings to conduct a larger scale&#xD;
      randomized trial (R01) to test the long-term efficacy of the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 16, 2019</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">October 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>waist circumference</measure>
    <time_frame>Change from baseline waist measurement at 3 months and 6 months</time_frame>
    <description>waist measured in centimeters by NIH waist circumference measurement protocol</description>
  </primary_outcome>
  <primary_outcome>
    <measure>breast cancer knowledge and attitudes</measure>
    <time_frame>Change from baseline breast cancer screening knowledge score at 3 months and 6 months</time_frame>
    <description>13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body mass index</measure>
    <time_frame>change from baseline BMI at 3 months and 6 months</time_frame>
    <description>Weight and height (weight [kg]/height [m])</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>self-efficacy</measure>
    <time_frame>Change from baseline self-efficacy questionnaire score at 3 months and 6 months</time_frame>
    <description>28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>food intake</measure>
    <time_frame>Change from baseline food frequency at 3 months and 6 months</time_frame>
    <description>Chinese food frequency questionnaire (FFQ) includes 118 food items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity</measure>
    <time_frame>Change from baseline daily physical activity at 3 months and 6 months</time_frame>
    <description>Daily tracking 10 hours awake time with a Fitbit device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood pressure</measure>
    <time_frame>Change from baseline blood pressure at 3 months and 6 months</time_frame>
    <description>Systolic and diastolic blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hemoglobin A1C</measure>
    <time_frame>Change from baseline hemoglobin A1C at 6 months</time_frame>
    <description>Glycated hemoglobin to measure average level of blood sugar</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lipid panel</measure>
    <time_frame>Change from baseline lipid panel at 6 months</time_frame>
    <description>A blood test that measures the level of different types of fat (lipid molecules) in the blood</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>Change from baseline lipid panel at 6 months</time_frame>
    <description>A blood test that measure the presence of inflammation in the body</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of uses of the tracking app</measure>
    <time_frame>at 6 months</time_frame>
    <description>Weekly number of uses of the tracking app</description>
  </other_outcome>
  <other_outcome>
    <measure>Frequency of accessing the 12 educational modules</measure>
    <time_frame>at 6 months</time_frame>
    <description>Weekly number of accessing the educational modules</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Obesity, Abdominal</condition>
  <condition>Cancer Prevention</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>. Daily use of a Fitbit Alta HRTM to identify behavior patterns.&#xD;
12 weekly SCOPP-CW educational modules delivered via WeChat.&#xD;
6 bi-weekly WeChat tailored messages based on based on the participant's tracker information, personal goals, and preferences</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>. Daily use of a Fitbit Alta HRTM to identify behavior patterns.&#xD;
12 weekly non-tailored educational modules on general health topics delivered via WeChat.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SCOPP-CW</intervention_name>
    <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.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control</intervention_name>
    <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.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be female&#xD;
&#xD;
          -  be at least 18 years old&#xD;
&#xD;
          -  have a waist circumference great than 80 cm&#xD;
&#xD;
          -  own a smartphone&#xD;
&#xD;
          -  be able to read Chinese and speak Mandarin&#xD;
&#xD;
          -  be premenopausal&#xD;
&#xD;
          -  have a child between the age of 1 and 18 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  are pregnant&#xD;
&#xD;
          -  gave birth less than 12 months prior to enrollment date&#xD;
&#xD;
          -  have a history of breast cancer&#xD;
&#xD;
          -  have an acute or life-threatening disease (e.g., renal failure).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fang-yu Chou, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>San Francisco State University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jyu-Lin Chen, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fang-yu Chou, PhD</last_name>
    <phone>415-3386853</phone>
    <email>fchou@sfsu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jyu-Lin Chen, PhD</last_name>
    <phone>415-5026015</phone>
    <email>Jyu-Lin.Chen@ucsf.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>San Francisco State University</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fang-yu Chou, PhD</last_name>
      <phone>415-338-6853</phone>
      <email>fchou@sfsu.edu</email>
    </contact>
    <investigator>
      <last_name>Jyu-Lin Chen, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>May 1, 2020</last_update_submitted>
  <last_update_submitted_qc>May 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Abdominal</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03805516
org study id: 20429001
nct id: NCT03805516
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: waist circumference
time frame: Change from baseline waist measurement at 3 months and 6 months
description: waist measured in centimeters by NIH waist circumference measurement protocol
measure: breast cancer knowledge and attitudes
time frame: Change from baseline breast cancer screening knowledge score at 3 months and 6 months
description: 13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening
measure: body mass index
time frame: change from baseline BMI at 3 months and 6 months
description: Weight and height (weight [kg]/height [m])
measure: self-efficacy
time frame: Change from baseline self-efficacy questionnaire score at 3 months and 6 months
description: 28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity
measure: food intake
time frame: Change from baseline food frequency at 3 months and 6 months
description: Chinese food frequency questionnaire (FFQ) includes 118 food items
measure: physical activity
time frame: Change from baseline daily physical activity at 3 months and 6 months
description: Daily tracking 10 hours awake time with a Fitbit device
measure: blood pressure
time frame: Change from baseline blood pressure at 3 months and 6 months
description: Systolic and diastolic blood pressure measured in mmHg
measure: Hemoglobin A1C
time frame: Change from baseline hemoglobin A1C at 6 months
description: Glycated hemoglobin to measure average level of blood sugar
measure: Lipid panel
time frame: Change from baseline lipid panel at 6 months
description: A blood test that measures the level of different types of fat (lipid molecules) in the blood
measure: C-reactive protein
time frame: Change from baseline lipid panel at 6 months
description: A blood test that measure the presence of inflammation in the body
measure: Number of uses of the tracking app
time frame: at 6 months
description: Weekly number of uses of the tracking app
measure: Frequency of accessing the 12 educational modules
time frame: at 6 months
description: Weekly number of accessing the educational modules
arm group label: Intervention
arm group type: Experimental
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 group label: Control
arm group type: Active Comparator
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: SCOPP-CW
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.
arm group label: Intervention
intervention type: Behavioral
intervention name: Control
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.
arm group label: Control
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fang-yu Chou, PhD
role: Principal Investigator
affiliation: San Francisco State University
last name: Jyu-Lin Chen, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Fang-yu Chou, PhD
phone: 415-3386853
email: fchou@sfsu.edu
last name: Jyu-Lin Chen, PhD
phone: 415-5026015
email: Jyu-Lin.Chen@ucsf.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Obesity
mesh term: Obesity, Abdominal
sharing ipd: No