Clinical trial NCT04326660: SCOPE-Chinese Women Study
Official title: The Smartphone-Based Cancer and Obesity Prevention Education Program for Chinese Women (SCOPE-Chinese Women)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Obesity, Abdominal
Keywords: Obesity
Abdominal
Cancer Prevention
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Central South University
First posted: 2020-03-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study will utilize a randomized control trail design with a control group.
Primary purpose: 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.

Eligibility 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).

Primary outcomes:
measure: Mean Change in Waist Circumference Over Time
timeFrame: Baseline, 3 months, and 6 months
Secondary outcomes:
measure: Mean Change in Body Mass Index (BMI) Over Time
timeFrame: Baseline, 3 months, and 6 months
measure: Mean Change in Scores on the Self-Rated Abilities for Health Practices Scale Over Time
timeFrame: Baseline, 3 months, and 6 months
measure: Mean Changes in China Food Frequency Questionnaire (FFQ) over time.
timeFrame: Baseline, 3 months, and 6 months
measure: Mean Changes in Overall Physical Activity
timeFrame: Baseline, 3 months, and 6 months
measure: Mean Change in Blood Pressure Over Time
timeFrame: Baseline, 3 months, and 6 months
measure: Mean Change in Hemoglobin A1C (HbA1C) Over Time
timeFrame: Baseline and 6 months
measure: Mean Change in Serum Lipid Levels Over Time
timeFrame: Baseline and 6 months
measure: Mean Change in Cortisol over time
timeFrame: Baseline and 6 months
Other outcomes:
measure: Percentage of Eligible participants Who Agree To Be Screened
timeFrame: At Baseline
measure: Number of Uses of The Tracking App Over Time
timeFrame: Baseline to 6 months
measure: Percentage of Participants who completed assessments
timeFrame: Up to 6 months
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Yuelu
country: China
facility: Central South University
state: Changsha, Hunan
Study officials:
affiliation: University of California, San Francisco
name: Jyu-Lin Chen, RN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Central South Univeristy
name: Jia Guo, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fan L, Strasser-Weippl K, Li JJ, St Louis J, Finkelstein DM, Yu KD, Chen WQ, Shao ZM, Goss PE. Breast cancer in China. Lancet Oncol. 2014 Jun;15(7):e279-89. doi: 10.1016/S1470-2045(13)70567-9.
citation: Jiang X, Tang H, Chen T. Epidemiology of gynecologic cancers in China. J Gynecol Oncol. 2018 Jan;29(1):e7. doi: 10.3802/jgo.2018.29.e7.
citation: Fair AM, Dai Q, Shu XO, Matthews CE, Yu H, Jin F, Gao YT, Zheng W. Energy balance, insulin resistance biomarkers, and breast cancer risk. Cancer Detect Prev. 2007;31(3):214-9. doi: 10.1016/j.cdp.2007.04.003. Epub 2007 Jul 23.
citation: Wang X, Li L, Gao J, Liu J, Guo M, Liu L, Wang W, Wang J, Xing Z, Yu Z, Wang X. The Association Between Body Size and Breast Cancer in Han Women in Northern and Eastern China. Oncologist. 2016 Nov;21(11):1362-1368. doi: 10.1634/theoncologist.2016-0147. Epub 2016 Aug 5.
citation: Cutrona CE, Abraham WT, Russell DW, Beach SR, Gibbons FX, Gerrard M, Monick M, Philibert R. Financial strain, inflammatory factors, and haemoglobin A1c levels in African American women. Br J Health Psychol. 2015 Sep;20(3):662-79. doi: 10.1111/bjhp.12120. Epub 2014 Oct 18.
citation: Landstedt E, Harryson L, Hammarstrom A. Changing housework, changing health? A longitudinal analysis of how changes in housework are associated with functional somatic symptoms. Int J Circumpolar Health. 2016 Jun 30;75:31781. doi: 10.3402/ijch.v75.31781. eCollection 2016.
citation: Berge JM, Larson N, Bauer KW, Neumark-Sztainer D. Are parents of young children practicing healthy nutrition and physical activity behaviors? Pediatrics. 2011 May;127(5):881-7. doi: 10.1542/peds.2010-3218. Epub 2011 Apr 11.
citation: Liu Y, Warren Andersen S, Wen W, Gao YT, Lan Q, Rothman N, Ji BT, Yang G, Xiang YB, Shu XO, Zheng W. Prospective cohort study of general and central obesity, weight change trajectory and risk of major cancers among Chinese women. Int J Cancer. 2016 Oct 1;139(7):1461-70. doi: 10.1002/ijc.30187. Epub 2016 May 31.
citation: Sun A, Cheng J, Bui Q, Liang Y, Ng T, Chen JL. Home-Based and Technology-Centered Childhood Obesity Prevention for Chinese Mothers With Preschool-Aged Children. J Transcult Nurs. 2017 Nov;28(6):616-624. doi: 10.1177/1043659617719139. Epub 2017 Jul 8.
citation: Guan X, Sun G, Zheng L, Hu W, Li W, Sun Y. Associations between metabolic risk factors and body mass index, waist circumference, waist-to-height ratio and waist-to-hip ratio in a Chinese rural population. J Diabetes Investig. 2016 Jul;7(4):601-6. doi: 10.1111/jdi.12442. Epub 2015 Dec 26.
citation: Wen X, Mai J, Gao X, Guo M, Wu Y, Liu X, Zhao L. [Cut-off values of waist circumference for central obesity in Chinese adults]. Zhonghua Xin Xue Guan Bing Za Zhi. 2015 Sep;43(9):822-6. Chinese.
citation: Nanayakkara J, Lekamwasam S. Validity of BMI, hip and waist circumferences as surrogate measures of obesity in a cohort of Sri Lankan premenopausal women. Ceylon Med J. 2013 Jun;58(2):72-5. doi: 10.4038/cmj.v58i2.4720.
citation: Singhal N, Mathur P, Pathak R. Validity of simple, novel measures of generalized and central obesity among young Asian Indian women. Indian J Med Sci. 2011 Dec;65(12):518-27.
citation: Yu R, Yan LL, Wang H, Ke L, Yang Z, Gong E, Guo H, Liu J, Gu Y, Wu Y. Effectiveness of a community-based individualized lifestyle intervention among older adults with diabetes and hypertension, Tianjin, China, 2008-2009. Prev Chronic Dis. 2014 May 15;11:E84. doi: 10.5888/pcd11.120333.
citation: Zhang R, Li Y, Zhang S, Cai X, Zhou X, Ji L. The Association of Retinopathy and Plasma Glucose and HbA1c: A Validation of Diabetes Diagnostic Criteria in a Chinese Population. J Diabetes Res. 2016;2016:4034129. doi: 10.1155/2016/4034129. Epub 2016 Oct 11.