SCOPE-Chinese Women Study
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 03/22/2020 |
| Estimated Enrollment Submitted: | 03/25/2020 |
| First Posted: | 03/29/2020 |
| Last Update Submitted: | 07/12/2020 |
| Last Update Posted: | 07/14/2020 |
| Actual Study Start Date: | 07/19/2020 |
| Estimated Primary Completion Date: | 12/30/2020 |
| Estimated Study Completion Date: | 12/29/2021 |
Condition or disease
Intervention/treatment
Other: SCOPE-Chinese Women Intervention
Phase
Arm Groups
| 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 Intervention 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Female |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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). |
Outcome
Primary Outcome Measures
1. Waist Circumference [Baseline, 3 months, and 6 months]
Secondary Outcome Measures
1. Body Mass Index (BMI) [Baseline, 3 months, and 6 months]
2. Self-Efficacy [Baseline, 3 months, and 6 months]
3. Food Intake [Baseline, 3 months, and 6 months]
4. Physical Activity [Baseline, 3 months, and 6 months]
5. Blood Pressure [Baseline, 3 months, and 6 months]
6. Hemoglobin A1C [Baseline and 6 months]
7. Serum lipids [Baseline and 6 months]
8. Cortisol [Baseline and 6 months]
Other Outcome Measures
1. Enrollment [Baseline to 6 months]
2. Usability [Baseline to 6 months]
3. Demographics [Collected at baseline]
4. Adherence [Baseline to 6 months]
