The Smartphone-Based Cancer and Obesity Prevention Education Program for Chinese Women (SCOPE-Chinese Women)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Mean Change in Waist Circumference Over Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
To decrease cross-contamination of treatment effect, the six study sites will be the units of randomization. A Statistical Package for Social Sciences (SPSS) program will be used to statistically match the groups and to randomly assign each study group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Mean Change in Waist Circumference Over Time
时间窗: 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.
次要结局
- Mean Change in Blood Pressure Over Time(Baseline, 3 months, and 6 months)
- Mean Changes in China Food Frequency Questionnaire (FFQ) over time.(Baseline, 3 months, and 6 months)
- Mean Change in Hemoglobin A1C (HbA1C) Over Time(Baseline and 6 months)
- Mean Change in Body Mass Index (BMI) Over Time(Baseline, 3 months, and 6 months)
- Mean Changes in Overall Physical Activity(Baseline, 3 months, and 6 months)
- Mean Change in Scores on the Self-Rated Abilities for Health Practices Scale Over Time(Baseline, 3 months, and 6 months)
- Mean Change in Serum Lipid Levels Over Time(Baseline and 6 months)
- Mean Change in Cortisol over time(Baseline and 6 months)