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Clinical Trials/NCT05279729
NCT05279729
Recruiting
Not Applicable

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

San Diego State University1 site in 1 country45 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
San Diego State University
Enrollment
45
Locations
1
Primary Endpoint
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months
Status
Recruiting
Last Updated
6 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
December 1, 2028
Last Updated
6 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 6 months

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

Secondary Outcomes

  • 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)

Study Sites (1)

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