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Central Obesity and Cancer Prevention for Chinese American Women

Central Obesity and Cancer Prevention for Chinese American Women

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03805516
Enrollment
18
Registered
2019-01-15
Start date
2019-10-16
Completion date
2021-08-31
Last updated
2023-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Prevention, Obesity, Abdominal

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.

Interventions

BEHAVIORALSCOPP-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.

BEHAVIORALControl

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.

Sponsors

University of California, San Francisco
CollaboratorOTHER
San Francisco State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
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).

Design outcomes

Primary

MeasureTime frameDescription
waist circumferenceChange from baseline waist measurement at 3 months and 6 monthswaist measured in centimeters by NIH waist circumference measurement protocol
breast cancer knowledge and attitudesChange from baseline breast cancer screening knowledge score at 3 months and 6 months13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening

Secondary

MeasureTime frameDescription
self-efficacyChange from baseline self-efficacy questionnaire score at 3 months and 6 months28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity
food intakeChange from baseline food frequency at 3 months and 6 monthsChinese food frequency questionnaire (FFQ) includes 118 food items
physical activityChange from baseline daily physical activity at 3 months and 6 monthsDaily tracking 10 hours awake time with a Fitbit device
Hemoglobin A1CChange from baseline hemoglobin A1C at 6 monthsGlycated hemoglobin to measure average level of blood sugar
Lipid panelChange from baseline lipid panel at 6 monthsA blood test that measures the level of different types of fat (lipid molecules) in the blood
C-reactive proteinChange from baseline lipid panel at 6 monthsA blood test that measure the presence of inflammation in the body
blood pressureChange from baseline blood pressure at 3 months and 6 monthsSystolic and diastolic blood pressure measured in mmHg
body mass indexchange from baseline BMI at 3 months and 6 monthsWeight and height (weight \[kg\]/height \[m\])

Other

MeasureTime frameDescription
Number of uses of the tracking appat 6 monthsWeekly number of uses of the tracking app
Frequency of accessing the 12 educational modulesat 6 monthsWeekly number of accessing the educational modules

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026