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Completed

NCT Number: NCT03805516

Central Obesity and Cancer Prevention for Chinese American Women

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco State University

San Francisco, California, 94132, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SCOPP-CW

Behavioral

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.

Control

Behavioral

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 outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

San Francisco State University

Other

Collaborators

  • University of California, San Francisco

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2019
Registry last updated
Nov 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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