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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus, Type 2; Obesity
• Interventions: Other: Mobile health application

• Registration Number: NCT05279729
• Lead Sponsor: San Diego State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-03-06
• Study First Posted: 2022-03-15
• Study Start: 2022-08-01
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01
• Primary Completion: 2028-10
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Weight Watchers (WW)	Mobile health application	-
Healthi app	Mobile health application	-

Primary Outcome Measures

Name	Time	Method
Effectiveness of mHealth apps at reducing bodyweight assessed by bodyweight measurements over 6 months	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	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	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	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	6 months	Compare and determine which intervention promotes self-efficacy in weight management

Secondary Outcome Measures

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

Trial Locations

Locations (1)

San Diego State University; 🇺🇸 San Diego, California, United States