Central Obesity and Cancer Prevention for Chinese American Women

Obesity, Abdominal Clinical Trial

Official title:

Central Obesity and Cancer Prevention for Chinese American Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805516
• Other study ID #: 20429001
• Status: Completed
• Phase: N/A
• Start date: October 16, 2019
• Est. completion date: August 31, 2021

Study information

• Verified date: November 2023
• Source: San Francisco State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: August 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer Prevention
• Obesity
• Obesity, Abdominal

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	San Francisco State University	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
San Francisco State University	University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of uses of the tracking app	Weekly number of uses of the tracking app	at 6 months
Other	Frequency of accessing the 12 educational modules	Weekly number of accessing the educational modules	at 6 months
Primary	waist circumference	waist measured in centimeters by NIH waist circumference measurement protocol	Change from baseline waist measurement at 3 months and 6 months
Primary	breast cancer knowledge and attitudes	13-item self-report questionnaire measuring knowledge, attitude, and practice of breast cancer screening	Change from baseline breast cancer screening knowledge score at 3 months and 6 months
Secondary	body mass index	Weight and height (weight [kg]/height [m])	change from baseline BMI at 3 months and 6 months
Secondary	self-efficacy	28-item self-report survey measuring self-efficacy on nutrition, stress management, physical activity	Change from baseline self-efficacy questionnaire score at 3 months and 6 months
Secondary	food intake	Chinese food frequency questionnaire (FFQ) includes 118 food items	Change from baseline food frequency at 3 months and 6 months
Secondary	physical activity	Daily tracking 10 hours awake time with a Fitbit device	Change from baseline daily physical activity at 3 months and 6 months
Secondary	blood pressure	Systolic and diastolic blood pressure measured in mmHg	Change from baseline blood pressure at 3 months and 6 months
Secondary	Hemoglobin A1C	Glycated hemoglobin to measure average level of blood sugar	Change from baseline hemoglobin A1C at 6 months
Secondary	Lipid panel	A blood test that measures the level of different types of fat (lipid molecules) in the blood	Change from baseline lipid panel at 6 months
Secondary	C-reactive protein	A blood test that measure the presence of inflammation in the body	Change from baseline lipid panel at 6 months