Cancer, Breast, Obesity, Abdominal
Conditions
Keywords
Obesity, Abdominal, Cancer Prevention
Brief summary
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.
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.
Interventions
OTHERSCOPE-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.
Sponsors
Central South University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
This pilot study will utilize a randomized control trail design with a control group.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Waist Circumference Over Time | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Changes in Overall Physical Activity | 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. |
| Mean Change in Hemoglobin A1C (HbA1C) Over Time | 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%. |
| Mean Change in Serum Lipid Levels Over Time | 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 |
| Mean Change in Cortisol over time | Baseline and 6 months | A blood sample will be collected to measure change in total cortisol levels over time for each participant. |
| Mean Change in Body Mass Index (BMI) Over Time | 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. |
| Mean Change in Scores on the Self-Rated Abilities for Health Practices Scale Over Time | 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. |
| Mean Changes in China Food Frequency Questionnaire (FFQ) over time. | 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. |
| Mean Change in Blood Pressure Over Time | Baseline, 3 months, and 6 months | Changes in blood pressure will be measured using the YuWell YE690A monitor for each participant over time. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who completed assessments | Up to 6 months | The percentage of completed assessments by participants at each visit will be used to measure adherence over time |
| Number of Uses of The Tracking App Over Time | 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 |
| Percentage of Eligible participants Who Agree To Be Screened | 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. |
Countries
China, United States
Outcome results
None listed