Obesity, AbdominalNCT03805516
Central Obesity and Cancer Prevention for Chinese American Women
A study testing SCOPP-CW in people with Obesity, Abdominal and Cancer Prevention, run by San Francisco State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Abdominal, Cancer Prevention
- What is being tested?
- SCOPP-CW
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2019to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco State University
San Francisco, California, 94132
About this study
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.
Read the 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.
- Conditions
- Obesity, Abdominal, Cancer Prevention
- Being tested
- SCOPP-CW, Control
- Medical subject headings
- Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCOPP-CWBehavioural
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.
ControlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns.
2. 12 weekly SCOPP-CW educational modules delivered via WeChat.
3. 6 bi-weekly WeChat tailored messages based on based on the participant's tracker information, personal goals, and preferences Receives: Behavioral: SCOPP-CW |
| Control | Active comparator | 1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns.
2. 12 weekly non-tailored educational modules on general health topics delivered via WeChat. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
waist circumference
waist measured in centimeters by NIH waist circumference measurement protocol
Measured: 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
Measured: Change from baseline breast cancer screening knowledge score at 3 months and 6 months
Secondary outcomes (8)
body mass index
Weight and height (weight [kg]/height [m])
Measured: 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
Measured: Change from baseline self-efficacy questionnaire score at 3 months and 6 months
food intake
Chinese food frequency questionnaire (FFQ) includes 118 food items
Measured: Change from baseline food frequency at 3 months and 6 months
physical activity
Daily tracking 10 hours awake time with a Fitbit device
Measured: Change from baseline daily physical activity at 3 months and 6 months
blood pressure
Systolic and diastolic blood pressure measured in mmHg
Measured: Change from baseline blood pressure at 3 months and 6 months
Hemoglobin A1C
Glycated hemoglobin to measure average level of blood sugar
Measured: 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
Measured: Change from baseline lipid panel at 6 months
C-reactive protein
A blood test that measure the presence of inflammation in the body
Measured: Change from baseline lipid panel at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start16 Oct 2019
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, AbdominalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Francisco State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Fang-yu Chou, PhD, Principal investigator, San Francisco State UniversityJyu-Lin Chen, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03805516
- Sponsor's protocol ID
- 20429001
- Status last verified
- Nov 2023
- First submitted
- 9 Jan 2019
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central Obesity and Cancer Prevention for Chinese American Women
- ClinicalTrials.gov ID
- NCT03805516
- Acronym / sponsor ID
- 20429001
- Conditions
- Obesity, Abdominal, Cancer Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- San Francisco State UniversityUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- 16 Oct 2019 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: SCOPP-CW1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns. 2. 12 weekly SCOPP-CW educational modules delivered via WeChat. 3. 6 bi-weekly WeChat tailored messages based on based on the participant's tracker information, personal goals, and preferences |
| Control | Active comparator | Behavioral: Control1. . Daily use of a Fitbit Alta HRTM to identify behavior patterns. 2. 12 weekly non-tailored educational modules on general health topics delivered via WeChat. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCOPP-CWThe 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. | Behavioural | Intervention |
| ControlThis 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. | Behavioural | Control |
Primary outcome
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
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
8 secondary outcomes
body mass index
Time frame: change from baseline BMI at 3 months and 6 months
self-efficacy
Time frame: Change from baseline self-efficacy questionnaire score at 3 months and 6 months
food intake
Time frame: Change from baseline food frequency at 3 months and 6 months
physical activity
Time frame: Change from baseline daily physical activity at 3 months and 6 months
blood pressure
Time frame: Change from baseline blood pressure at 3 months and 6 months
Hemoglobin A1C
Time frame: Change from baseline hemoglobin A1C at 6 months
Lipid panel
Time frame: Change from baseline lipid panel at 6 months
C-reactive protein
Time frame: Change from baseline lipid panel at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang-yu Chou, PhD principal investigator
San Francisco State University
Jyu-Lin Chen, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SCOPP-CW in people with Obesity, Abdominal and Cancer Prevention, run by San Francisco State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
waist circumference (time frame: Change from baseline waist measurement at 3 months and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2023.