Central Obesity and Cancer Prevention for Chinese American Women

Sponsor
San Francisco State University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03805516
Collaborator
University of California, San Francisco (Other)
30
1
2
13.5
2.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SCOPP-CW
  • Behavioral: Control
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Oct 16, 2019
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Dec 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention

. 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

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

. Daily use of a Fitbit Alta HRTM to identify behavior patterns. 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.

Outcome Measures

Primary Outcome Measures

  1. waist circumference [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 [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 [change from baseline BMI at 3 months and 6 months]

    Weight and height (weight [kg]/height [m])

  2. self-efficacy [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 [Change from baseline food frequency at 3 months and 6 months]

    Chinese food frequency questionnaire (FFQ) includes 118 food items

  4. physical activity [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 [Change from baseline blood pressure at 3 months and 6 months]

    Systolic and diastolic blood pressure measured in mmHg

  6. Hemoglobin A1C [Change from baseline hemoglobin A1C at 6 months]

    Glycated hemoglobin to measure average level of blood sugar

  7. Lipid panel [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 [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 [at 6 months]

    Weekly number of uses of the tracking app

  2. Frequency of accessing the 12 educational modules [at 6 months]

    Weekly number of accessing the educational modules

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 San Francisco State University San Francisco California United States 94132

Sponsors and Collaborators

  • San Francisco State University
  • University of California, San Francisco

Investigators

  • Principal Investigator: Fang-yu Chou, PhD, San Francisco State University
  • Principal Investigator: Jyu-Lin Chen, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
San Francisco State University
ClinicalTrials.gov Identifier:
NCT03805516
Other Study ID Numbers:
  • 20429001
First Posted:
Jan 15, 2019
Last Update Posted:
May 5, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 5, 2020