San Francisco State University
San Francisco, California, 94132, United States
NCT Number: NCT03805516
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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Notify Me18 year and older
Female
Interventional
Not applicable
San Francisco, California, 94132, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Change from baseline waist measurement at 3 months and 6 months
waist measured in centimeters by NIH waist circumference measurement protocol
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
Time frame: change from baseline BMI at 3 months and 6 months
Weight and height (weight [kg]/height [m])
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
Time frame: Change from baseline food frequency at 3 months and 6 months
Chinese food frequency questionnaire (FFQ) includes 118 food items
Time frame: Change from baseline daily physical activity at 3 months and 6 months
Daily tracking 10 hours awake time with a Fitbit device
Time frame: Change from baseline blood pressure at 3 months and 6 months
Systolic and diastolic blood pressure measured in mmHg
Time frame: Change from baseline hemoglobin A1C at 6 months
Glycated hemoglobin to measure average level of blood sugar
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
Time frame: Change from baseline lipid panel at 6 months
A blood test that measure the presence of inflammation in the body
Time frame: at 6 months
Weekly number of uses of the tracking app
Time frame: at 6 months
Weekly number of accessing the educational modules
San Francisco State University
Other
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