Central Obesity and Cancer Prevention for Chinese American Women

Study Overview
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Brief Summary
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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
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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.

Official Title
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Central Obesity and Cancer Prevention for Chinese American Women

Conditions
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Obesity, Abdominal, Cancer Prevention

Intervention / Treatment
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* Behavioral: SCOPP-CW
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>. 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<br>* 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.<br>|
| Active Comparator: Control<br>. 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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| waist circumference | waist measured in centimeters by NIH waist circumference measurement protocol | Change from baseline waist measurement at 3 months and 6 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body mass index | Weight and height (weight [kg]/height [m]) | change from baseline BMI at 3 months and 6 months | 
| 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 | 
| food intake | Chinese food frequency questionnaire (FFQ) includes 118 food items | Change from baseline food frequency at 3 months and 6 months | 
| physical activity | Daily tracking 10 hours awake time with a Fitbit device | Change from baseline daily physical activity at 3 months and 6 months | 
| blood pressure | Systolic and diastolic blood pressure measured in mmHg | Change from baseline blood pressure at 3 months and 6 months | 
| Hemoglobin A1C | Glycated hemoglobin to measure average level of blood sugar | Change from baseline hemoglobin A1C at 6 months | 
| 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 | 
| C-reactive protein | A blood test that measure the presence of inflammation in the body | Change from baseline lipid panel at 6 months |