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NCT Number: NCT05279729

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University

San Diego, California, 92182, United States

Location status: Recruiting

Location contact

Mee Young Hong, PhD

CONTACT

[email protected]

619-594-2392

Mee Young Hong, PhD

PRINCIPAL_INVESTIGATOR

Robert J Castro, BS

CONTACT

[email protected]

6193636120

Robert J Castro, BS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile health application

Other

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

Primary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire

    Time frame: 6 months

    Comparing the three interventions to determine which leads to greater quality of life (QOL)

  2. mhealthy app preference assessed by questionnaire

    Time frame: 6 months

    Which mHealth app is more economically feasible for the participants and if feasibility changes after app usage. Outcome will be assessed with a questionnaire asking if the participant can afford the app.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Mar 15, 2022
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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