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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Mobile health application

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92182
      • Recruiting
      • San Diego State University
      • Contact: Mee Young Hong, PhD; Phone Number: 619-594-2392; Email: mhong2@sdsu.edu
      • Contact: Robert J Castro, BS; Phone Number: 6193636120; Email: rcastro0271@sdsu.edu
      • Principal Investigator: Mee Young Hong, PhD
      • Principal Investigator: Robert J Castro, BS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Weight Watchers (WW)	Other: Mobile health application; Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)
Experimental: Healthi app	Other: Mobile health application; Intervention will be with two different mobile health (mHealth) applications, Weight Watchers and Healthi app (formerly iTrackBites)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 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)	6 months
Most effect intervention for weight loss in first 3 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	6 months
Most effective intervention for weight loss by 6 months	Compare and determine which intervention leads to the highest weight loss maintenance after six months	6 months
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire	Compare and determine which intervention promotes self-efficacy in weight management	6 months
Long term diabetes improvement via A1c	Compare and determine which intervention provides the best improvements towards diabetes via blood glucose and HbA1c	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire	Comparing the three interventions to determine which leads to greater quality of life (QOL)	6 months
mhealthy app preference assessed by questionnaire	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.	6 months

Collaborators and Investigators

• Sponsor: San Diego State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 6, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Estimated): October 6, 2025
• Last Update Submitted That Met QC Criteria: September 30, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; mhealth; ehealth; low income
• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus
• Other Study ID Numbers: HS-2021-0245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No