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临床试验/NCT05279729
NCT05279729招募中不适用

Efficacy of mHealth Apps for Health in a Low-income, Type II Diabetic, Hispanic

San Diego State University2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
45
试验地点
2
主要终点
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months

研究概览

简要总结

The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and the subsequent benefit of improving type II diabetes outcomes in a low socioeconomic Hispanic population. This study will involve a 6-month long commitment where participants will be expected to weigh themselves every morning, at the same time, and check their blood glucose readings daily before and after meals for at least three meals in the day.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with type II diabetes
  • Between the age of 18-64
  • Individual annual income less than $47,520 [Covered CA income guidelines and salary restrictions]
  • Hispanic and/or Latinx origin
  • Monitors blood glucose regularly
  • Owns or has access to a bathroom weight scale
  • Owns a smartphone and willing to download mobile apps

排除标准

  • Does not check blood glucose at least once per day
  • On medications that promote weight gain such as antipsychotic, antidepressant, and steroid hormone medications.
  • Medications for diabetes such as insulin, thiazolidinediones or sulfonylureas are okay

结局指标

主要结局

Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months

时间窗: 6 months

Determine if mHealth apps-Weight Watchers (WW) and Healthi app-are an effective weight loss modality compared to standard weight loss program (control)

Long term diabetes improvement via A1c

时间窗: 6 months

Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c

Most effect intervention for weight loss in first 3 months

时间窗: 6 months

Compare the three interventions, mHealth apps and control, against each other to determine which is most effective at achieving the maximum amount of weight loss within the first three months

Most effective intervention for weight loss by 6 months

时间窗: 6 months

Compare and determine which intervention leads to the highest weight loss maintenance after six months

Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire

时间窗: 6 months

Compare and determine which intervention promotes self-efficacy in weight management

次要结局

  • mhealthy app preference assessed by questionnaire(6 months)
  • Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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