SCOPE-Chinese Women Study

NCT04326660 | Completed

• 2 other identifiers: 18-27025217516
• Study Type: interventional
• Target: 40
• Locations: 2 countries
• Sites: 2

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.

Conditions

Cancer, Breast; Obesity, Abdominal

Keywords

Obesity; Abdominal; Cancer Prevention

Outcome Measures

Primary Outcomes (1)

• Mean Change in Waist Circumference Over Time

  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 Outcomes (8)

• Mean Change in Body Mass Index (BMI) Over Time

  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 Changes in China Food Frequency Questionnaire (FFQ) over time.

  Baseline, 3 months, and 6 months

• Mean Changes in Overall Physical Activity

  Baseline, 3 months, and 6 months

• Mean Change in Blood Pressure Over Time

  Baseline, 3 months, and 6 months

Other Outcomes (3)

• Percentage of Eligible participants Who Agree To Be Screened

  At Baseline

• Number of Uses of The Tracking App Over Time

  Baseline to 6 months

• Percentage of Participants who completed assessments

  Up to 6 months

Study Arms (2)

Control

NO INTERVENTION

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.

SCOPE-Chinese Women Intervention

EXPERIMENTAL

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

Interventions

SCOPE-Chinese Women OTHER

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.

SCOPE-Chinese Women Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, San Francisco: lead
• Central South University: collaborator

Study Sites (2)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Central South University

Yuelucun, Changsha, Hunan, 410083, China

Location

Related Publications (15)

• 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.

  PMID: 24872111 BACKGROUND

• 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.

  PMID: 29185265 BACKGROUND

• 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.

  PMID: 17646056 BACKGROUND

• 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.

  PMID: 27496041 BACKGROUND

• 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.

  PMID: 25327694 BACKGROUND

• 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.

  PMID: 27369590 BACKGROUND

• 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.

  PMID: 21482603 BACKGROUND

• 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.

  PMID: 27177094 BACKGROUND

• 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.

  PMID: 28826348 BACKGROUND

• 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.

  PMID: 27181937 BACKGROUND

• 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.

  PMID: 26652826 BACKGROUND

• 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.

  PMID: 23817937 BACKGROUND

• 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.

  PMID: 23548252 BACKGROUND

• 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.

  PMID: 24831288 BACKGROUND

• 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.

  PMID: 27807545 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Obesity, Abdominal; Obesity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jyu-Lin Chen, RN, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Jia Guo, RN, PhD

  Central South Univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This pilot study will utilize a randomized control trail design with a control group.

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 30, 2020
• Study Start: July 20, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CN (1)