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Recruiting NCT05279729

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

No phase Interventional Diabetes Mellitus, Type 2 Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mobile health application.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2, Obesity. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Other Mobile health application
    Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)

Primary outcome measures

  • Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months [Time frame: 6 months]
  • Most effect intervention for weight loss in first 3 months [Time frame: 6 months]
  • Most effective intervention for weight loss by 6 months [Time frame: 6 months]
  • Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire [Time frame: 6 months]
  • Long term diabetes improvement via A1c [Time frame: 6 months]
Secondary outcome measures (2)
  • Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire [Time frame: 6 months]
  • mhealthy app preference assessed by questionnaire [Time frame: 6 months]

Eligibility criteria

Inclusion criteria

  • Diagnosed with type II diabetes
  • Between the age of 18-64
  • BMI ≥ 27
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • San Diego State University — San Diego

Identifiers

NCT: NCT05279729 · HS-2021-0245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗