SCOPE-Chinese Women Study (SCOPE)

December 21, 2022 updated by: University of California, San Francisco

The Smartphone-Based Cancer and Obesity Prevention Education Program for Chinese Women (SCOPE-Chinese Women)

This project examines the feasibility of a smartphone-based intervention to reduce obesity and breast cancer risk among Chinese women in China. The proposed intervention is to use the mobile application and an activity tracker device to promote a healthier lifestyle and physical activity. The intervention will be tailored to the participants' behaviors, personal needs, and preferences. The aim is to reduce abdominal obesity and improve healthy lifestyle behaviors in premenopausal women with children in order to reduce the growing cancer burden in China.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cancer presents a major disease burden across the globe. The incidence and mortality of gynecologic cancers have increased significantly in China over the last two decades with breast and endometrial cancer as leading causes of death in women in China. Obesity, especially abdominal obesity, and unhealthy lifestyles are major risk factors for breast and endometrial cancer. A high risk group for obesity is mothers with dependent children as they have high levels of stress and family responsibilities that prevent regular engagement in a healthy lifestyle and early screening activities. Because reducing postmenopausal abdominal obesity is very difficult and because of the significant increased risk for gynecologic cancers in obese postmenopausal women, interventions that aim to reduce abdominal obesity and improve healthy lifestyle behaviors in premenopausal women with children are critical to reducing the growing cancer burden in China. A smartphone-based intervention provides a promising platform for obesity and cancer prevention. In this proposed study, the research team will modify the Healthy Mothers Healthy Children: Technology-Based Intervention to Prevent Obesity, which was developed by the principal investigator. The proposed intervention (titled "The Smartphone-Based Cancer and Obesity Prevention Education Program for Chinese Women: SCOPE-Chinese Women") is a smartphone-based, data-driven, and individually tailored intervention. It includes 12 weekly educational modules and six bi-weekly tailored messages delivered via WeChat, a popular communication app in China. The intervention will also be tailored to the participants' behaviors, personal needs, and preferences. The overall goal of this proposed study is to assess the feasibility and estimate the preliminary efficacy of the SCOPE-Chinese Women intervention using a randomized control study design (RCT). The following aims will be addressed.

Aim 1: To assess the feasibility of the smartphone-based lifestyle intervention (i.e., SCOPE-Chinese Women).

Aim 2: To estimate the preliminary efficacy of the SCOPE-Chinese Women intervention on the primary outcome (waist circumference) and secondary outcomes (body mass index, self-efficacy, food intake, physical activity, and metabolic risk) between the intervention and control groups at baseline, 3 months, and 6 months.

Aim 3: To understand participants' acceptance, barriers to adherence, and recommendations for intervention.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Changsha, Hunan
      • Yuelu, Changsha, Hunan, China, 410083
        • Central South University
  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Participants must:

  • 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:

Women are excluded from the study if they:

  • Are pregnant
  • Gave birth less than 12 months prior to enrollment date
  • Have an acute or life-threatening disease (e.g., renal failure).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Participants in the control group will receive a Fitbit Alta-Heart Rate (HR) and 12 weekly non-tailored educational modules via WeChat on general health topics that are important to 20-45 year-old women in China. Topics include intimate partner violence, anxiety, depression, sexually transmitted infections, HIV, unintended pregnancy, hepatitis B, and general cancer prevention.
Experimental: SCOPE-Chinese Women Intervention

SCOPE-Chinese Women intervention content and methods: SCOPE-Chinese Women is a smartphone- based intervention.

Component 1. All study participants will receive a Fitbit Alta-HR tracking device to wear daily. Each participant will receive in-person, training on how to access the app and their tracking data. If a participant has not used the fitness device and app for more than one week, a WeChat reminder message will be sent to the participant.

Component 2. Participants will receive 12 weekly culturally appropriate and evidence-based SCOPE-Chinese Women educational modules along with tailored tips and messages via WeChat. Each module will include three educational sessions that last less than 45 minutes total.

Component 3. Six bi-weekly messages will be sent to participants via WeChat to encourage positive behavioral changes. Each participant's message content will be based on the participant's tracker information, personal goals, and preferences.
Other: SCOPE-Chinese Women
SCOPE-Chinese Women is a smart-phone based intervention that includes a Fitbit tracking device to monitor daily activity, 12-weeks of educational modules delivered by WeChat, and Bi-weekly messages that encourage positive behavioral change. The data will be examined by the research team to assess efficacy of the intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Waist Circumference Over Time
Time Frame: Baseline, 3 months, and 6 months
The National Institutes of Health (NIH) waist circumference measurement protocol will be used to measure change in waist circumference for each participant over time.
Baseline, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change in Body Mass Index (BMI) Over Time
Time Frame: Baseline, 3 months, and 6 months
Weight and height will be used to compute the BMI with the formula=weight (kilograms(kg)) / height in (meters squared (m2). Changes in BMI will be collected for each participant over time.
Baseline, 3 months, and 6 months
Mean Change in Scores on the Self-Rated Abilities for Health Practices Scale Over Time
Time Frame: Baseline, 3 months, and 6 months
The Self Rated Abilities for Health Practices Scale (SRAHP) is a 28-item survey, with each item scored on a 5-point scale, with item scores ranging from 0=Not at all to 4=Completely. The survey is designed to measure self-perceived ability to implement health-promoting behaviors across four subscales: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being, and overall. The total score ranges from 0 - 112, with higher scores indicating greater abilities for health practices. Changes in scores will be collected for each participant over time.
Baseline, 3 months, and 6 months
Mean Changes in China Food Frequency Questionnaire (FFQ) over time.
Time Frame: Baseline, 3 months, and 6 months
Food intake using the China food frequency questionnaire (FFQ), which includes a list of 118 food items will be used to measure aggregate changes in food intake over time.
Baseline, 3 months, and 6 months
Mean Changes in Overall Physical Activity
Time Frame: Baseline, 3 months, and 6 months
Change in overall Physical activity over time will be measured using the Fitbit Alta-HR device for 10 hours while participants are awake.
Baseline, 3 months, and 6 months
Mean Change in Blood Pressure Over Time
Time Frame: Baseline, 3 months, and 6 months
Changes in blood pressure will be measured using the YuWell YE690A monitor for each participant over time.
Baseline, 3 months, and 6 months
Mean Change in Hemoglobin A1C (HbA1C) Over Time
Time Frame: Baseline and 6 months
A blood sample will be collected to measure change in HbA1C over time for each participant, using an established cut off value at 6.4%.
Baseline and 6 months
Mean Change in Serum Lipid Levels Over Time
Time Frame: Baseline and 6 months
A blood sample will be collected to measure change in total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides (all measured in milligrams per deciliter (mg/dL)) over time for each participant
Baseline and 6 months
Mean Change in Cortisol over time
Time Frame: Baseline and 6 months
A blood sample will be collected to measure change in total cortisol levels over time for each participant.
Baseline and 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eligible participants Who Agree To Be Screened
Time Frame: At Baseline
The number of overall eligible participants and the number of eligible participants who agree to be screened will be used to compute the percentage used for enrollment.
At Baseline
Number of Uses of The Tracking App Over Time
Time Frame: Baseline to 6 months
The number of uses of the tracking app and frequency of accessing the 12 modules, to measure change in usability over time
Baseline to 6 months
Percentage of Participants who completed assessments
Time Frame: Up to 6 months
The percentage of completed assessments by participants at each visit will be used to measure adherence over time
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Central South University

Investigators

  • Principal Investigator: Jyu-Lin Chen, RN, PhD, University of California, San Francisco
  • Principal Investigator: Jia Guo, RN, PhD, Central South Univeristy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

March 23, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 30, 2020

Study Record Updates

Last Update Posted (Estimate)

December 22, 2022

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-27025
  • 217516 (University of California, San Francisco)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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