SCOPE-Kiinan naisten tutkimus (SCOPE)
Älypuhelimeen perustuva syövän ja lihavuuden ehkäisyn koulutusohjelma kiinalaisille naisille (SCOPE-Chinese Women)
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.
Tutkimuksen yleiskatsaus
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
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Changsha, Hunan
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Yuelucun, Changsha, Hunan, Kiina, 410083
- Central South University
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California
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San Francisco, California, Yhdysvallat, 94143
- University of California, San Francisco
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Ennaltaehkäisy
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Ei väliintuloa: 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. |
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Kokeellinen: 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. |
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mean Change in Waist Circumference Over Time
Aikaikkuna: Baseline, 3 months, and 6 months
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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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Mean Change in Body Mass Index (BMI) Over Time
Aikaikkuna: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Mean Change in Scores on the Self-Rated Abilities for Health Practices Scale Over Time
Aikaikkuna: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Mean Changes in China Food Frequency Questionnaire (FFQ) over time.
Aikaikkuna: Baseline, 3 months, and 6 months
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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. |
Baseline, 3 months, and 6 months
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Mean Changes in Overall Physical Activity
Aikaikkuna: Baseline, 3 months, and 6 months
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Change in overall Physical activity over time will be measured using the Fitbit Alta-HR device for 10 hours while participants are awake. |
Baseline, 3 months, and 6 months
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Mean Change in Blood Pressure Over Time
Aikaikkuna: Baseline, 3 months, and 6 months
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Changes in blood pressure will be measured using the YuWell YE690A monitor for each participant over time. |
Baseline, 3 months, and 6 months
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Mean Change in Hemoglobin A1C (HbA1C) Over Time
Aikaikkuna: Baseline and 6 months
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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%. |
Baseline and 6 months
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Mean Change in Serum Lipid Levels Over Time
Aikaikkuna: Baseline and 6 months
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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 |
Baseline and 6 months
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Mean Change in Cortisol over time
Aikaikkuna: Baseline and 6 months
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A blood sample will be collected to measure change in total cortisol levels over time for each participant. |
Baseline and 6 months
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Relative telomere length (RTL)
Aikaikkuna: baseline and 6 months follow-up.
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A blood sample will be collected to measure relative telomere length (RTL), assessed using the real-time quantitative polymerase chain reaction (qPCR) technique, adhering to the protocol specified by Cawthon. |
baseline and 6 months follow-up.
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Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Percentage of Eligible participants Who Agree To Be Screened
Aikaikkuna: At Baseline
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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. |
At Baseline
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Number of Uses of The Tracking App Over Time
Aikaikkuna: Baseline to 6 months
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The number of uses of the tracking app and frequency of accessing the 12 modules, to measure change in usability over time |
Baseline to 6 months
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Percentage of Participants who completed assessments
Aikaikkuna: Up to 6 months
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The percentage of completed assessments by participants at each visit will be used to measure adherence over time |
Up to 6 months
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Yhteistyökumppanit ja tutkijat
Yhteistyökumppanit
Tutkijat
- Päätutkija: Jyu-Lin Chen, RN, PhD, University of California, San Francisco
- Päätutkija: Jia Guo, RN, PhD, Central South Univeristy
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 18-27025
- 217516 (Muu tunniste: University of California, San Francisco)
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Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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