NCT05279729

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus-type-2

Timeline
31mo left

Started Aug 2022

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Aug 2022Dec 2028

First Submitted

Initial submission to the registry

February 23, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 15, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

6.2 years

First QC Date

February 23, 2022

Last Update Submit

September 30, 2025

Conditions

Diabetes Mellitus, Type 2Obesity

Keywords

diabeteslow incomemhealthehealth

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (2)

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

    6 months

  • mhealthy app preference assessed by questionnaire

    6 months

Study Arms (3)

Control

NO INTERVENTION

Weight Watchers (WW)

EXPERIMENTAL
Other: Mobile health application

Healthi app

EXPERIMENTAL
Other: Mobile health application

Interventions

Mobile health applicationOTHER

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

Healthi appWeight Watchers (WW)

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

March 15, 2022

Study Start

August 1, 2022

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)