NCT05589155

Brief Summary

The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes and type II diabetes outcomes in type 2 diabetics. 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
30

participants targeted

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

Timeline
26mo left

Started Oct 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

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Study Timeline

Key milestones and dates

Study Progress63%
Oct 2022Jul 2028

Study Start

First participant enrolled

October 1, 2022

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

October 16, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2028

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

5.8 years

First QC Date

October 16, 2022

Last Update Submit

September 30, 2025

Conditions

Keywords

diabetesmhealthehealth

Outcome Measures

Primary Outcomes (4)

  • Effectiveness of mHealth apps at changing bodyweight assessed by bodyweight measurements over 6 months

    Determine if mhealth app is an effective weight loss modality compared to standard weight loss program (control) Outcome measure will be body weight in kg

    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. Reporting will be on a scale of 0-100, with higher scores indicating higher self-efficacy

    6 months

  • Long term change in diabetes via A1c

    Compare and determine which intervention elicits the most change towards diabetes via HbA1c Outcome measure will be HbA1c

    6 months

  • Long term change in diabetes via fasting blood glucose

    Compare and determine which intervention elicits the most change towards diabetes via fasting blood glucose Outcome measure will be fasting blood glucose

    6 months

Secondary Outcomes (1)

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

    6 months

Study Arms (2)

Control

NO INTERVENTION

Healthi

EXPERIMENTAL
Other: Mobile health application

Interventions

Intervention will be with mobile health application

Healthi

Eligibility Criteria

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

You may qualify if:

  • Diagnosed with type II diabetes for at least 3 months
  • Between the age of 18-64
  • BMI ≥ 25
  • Monitors blood glucose regularly (at least once per day)
  • Owns or has access to a bathroom weight scale
  • Owns a smartphone and willing to download mobile app

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 oka

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

October 16, 2022

First Posted

October 21, 2022

Study Start

October 1, 2022

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

July 1, 2028

Last Updated

October 6, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations