NCT05726942

Brief Summary

The purpose of this study is to determine the effectiveness of mobile health applications in improving health outcomes in patients with overweight and obesity. This study will involve a 6-month long commitment where participants will be expected to use an mHealth app daily, weigh themselves and check their fasting blood glucose levels every morning.

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

Timeline
21mo left

Started Jan 2023

Longer than P75 for not_applicable

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 Progress67%
Jan 2023Jan 2028

Study Start

First participant enrolled

January 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

October 2, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

February 3, 2023

Last Update Submit

September 30, 2025

Conditions

Keywords

adiposity

Outcome Measures

Primary Outcomes (4)

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

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

    3 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

    3 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

    3 months

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

    Comparing the two arms to determine which leads to greater quality of life (QOL) Measures will be reported on a scale of 1-5 across four domains. Scores will be converted to a scale of 0-100

    3 months

Study Arms (2)

Healthi

EXPERIMENTAL
Other: Healthi

Control

NO INTERVENTION

Interventions

HealthiOTHER

Healthi refers to the Healthi app, which is a mobile application for weight loss

Healthi

Eligibility Criteria

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

You may qualify if:

  • Between the age of 18-64
  • BMI ≥ 25
  • Owns or has access to a bathroom weight scale
  • Owns a smartphone and willing to download mobile app

You may not qualify if:

  • 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

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody 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 3, 2023

First Posted

February 14, 2023

Study Start

January 1, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 31, 2028

Last Updated

October 2, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations