跳至主要内容
临床试验/NCT03557697
NCT03557697已完成不适用

A Mobile Health Intervention to Reduce Diabetes Disparities in Chinese Americans

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels

研究概览

简要总结

Chinese Americans are one of the fastest growing immigrant groups in the US, who suffer disproportionately high type 2 diabetes (T2D) burden and have poorly controlled T2D. Despite the well-documented T2D disparities in this minority group, limited work has been conducted to improve health outcomes in Chinese Americans. The goal of this Pathway to Independence Award (K99/R00) is to expedite the candidate's transition to an independent investigator who possesses focused expertise in development and evaluation of culturally and linguistically tailored and sustainable interventions to reduce T2D disparities in Chinese Americans. In the K99 phase of this award, the candidate will obtain critical training needed to accomplish this goal and will develop a short message service (SMS) intervention to improve T2D management in Chinese Americans.

More specifically, the aims are to 1) characterize barriers and facilitators of glycemic control in Chinese Americans with T2D (Aim 1a); 2) develop culturally and linguistically tailored SMS intervention content (Aim 1b); and 3) assess the feasibility and acceptability of the SMS intervention in a pre-, post-test study (Aim 1c).

In the R00 phase, the candidate will refine the SMS intervention based on the K99 pilot data and evaluate the proof-of-concept regarding its efficacy in a pilot randomized controlled trial among 66 Chinese Americans with T2D (Aim 2). Participants will be randomized to one of 2 arms (n=30 each): 1) wait-list control and 2) SMS intervention. Both groups will continue to receive standard of care treatment for their T2D. The SMS group will receive brief lifestyle counseling videos via SMS links. At the end of the study, the wait-list control group will be provided the opportunity to receive the SMS-based counseling videos. Measurements will be obtained at baseline, 3, and 6 months. The primary outcome is HbA1c and secondary outcomes include self-efficacy, diabetes self-management behaviors, dietary intake and physical activity behaviors. Linear mixed modeling will be used to examine the group and group by time interaction effects between the SMS intervention and wait-list control group. Findings from this R00 study will inform a larger full-scale R01 efficacy trial of the SMS intervention, and ultimately, establish the candidate's program of research focused on developing and testing sustainable interventions to reduce disparities in chronic disease outcomes in Chinese Americans. This project can serve as a program model for other chronic disease interventions in Chinese Americans that require lifestyle modification (e.g., prediabetes, hypertension), or for disparities research in other high-risk immigrant populations (e.g., South Asians, Hispanic Americans).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • self-identify as Chinese Immigrant or Chinese American
  • be able to speak and understand Mandarin
  • self-report a diagnosis of T2D
  • baseline HbA1c ≥ 7%
  • be currently using WeChat or text messages• be willing to receive WeChat or text messages regarding T2D management
  • express strong interest and confidence in finishing watching 2 diabetes videos each week for a total of 12 weeks
  • express motivation to make lifestyle changes to control their diabetes
  • be willing to wear ActiGraph for 8 days

排除标准

  • unable or unwilling to provide informed consent
  • unable to participate meaningfully in the intervention (e.g., uncorrected sight and hearing impairment)
  • unwilling to accept randomization assignment
  • pregnant, plans to becomes pregnant in the next 6 months, or who become pregnant during the study
  • breastfeeding
  • live in a facility or other health care setting where they have to control over diabetes self-management

结局指标

主要结局

Change in Average Plasma Glucose Concentration Measured by Hemoglobin A1c (HbA1c) Levels

时间窗: Baseline, Month 6

HbA1c testing results abstracted from medical record.

次要结局

  • Change in Stanford Diabetes Self-Efficacy Scale Score(Baseline, Month 6)
  • Change in Summary of Diabetes Self-Care Activities (SDSCA) - General Diet Score(Baseline, Month 6)
  • Change in Summary of Diabetes Self-Care Activities (SDSCA) - Specific Diet Score(Baseline, Month 6)
  • Change in Summary of Diabetes Self-Care Activities (SDSCA) - Exercise Score(Baseline, Month 6)
  • Change in Summary of Diabetes Self-Care Activities (SDSCA) - Blood-Glucose Testing Score(Baseline, Month 6)
  • Change in Summary of Diabetes Self-Care Activities (SDSCA) - Foot Care Score(Baseline, Month 6)
  • Change in Summary of Diabetes Self-Care Activities (SDSCA) - Medication Adherence Score(Baseline, Month 6)
  • Change in Starting The Conversation Scale: Fruits(Baseline, Month 6)
  • Change in Starting The Conversation Scale: Vegetables(Baseline, Month 6)
  • Change in Starting The Conversation Scale: Refined Grains(Baseline, Month 6)
  • Change in Starting The Conversation Scale: Whole Wheat(Baseline, Month 6)
  • Change in Starting The Conversation Scale: Sugary Drinks(Baseline, Month 6)
  • Change in Starting The Conversation Scale: Starchy Foods(Baseline, Month 6)
  • Change in International Physical Activity Questionnaire (IPAQ) Score(Baseline, Month 6)
  • Change in Belief in Self-Management Score(Baseline, Month 6)
  • Change in Diabetes Distress Scale Score(Baseline, Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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