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Clinical Trials/NCT05589155
NCT05589155
Recruiting
Not Applicable

Efficacy of Using Mobile Health Applications for Health

San Diego State University1 site in 1 country30 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 2
Sponsor
San Diego State University
Enrollment
30
Locations
1
Primary Endpoint
Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire
Status
Recruiting
Last Updated
6 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
July 1, 2028
Last Updated
6 months ago
Study Type
Interventional
Study Design
Factorial
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with type II diabetes for at least 3 months
  • Between the age of 18-64
  • 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

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 oka

Outcomes

Primary Outcomes

Self-efficacy in weight management assessed by Weight Management and Nutrition Knowledge questionnaire

Time Frame: 6 months

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

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

Time Frame: 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

Long term change in diabetes via A1c

Time Frame: 6 months

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

Long term change in diabetes via fasting blood glucose

Time Frame: 6 months

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

Secondary Outcomes

  • Quality of Life after using mHealth apps assessed by World Health Organization Quality of Life BREF questionnaire(6 months)

Study Sites (1)

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