Efficacy of mHealth Applications in Weight Management in a Population Affected by Overweight or Obesity

Overweight and Obesity Clinical Trial

Official title:

Efficacy of mHealth Applications in Weight Management in a Population Affected by Overweight or Obesity

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05726942
• Other study ID #: HS-2022-0256
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: February 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 31, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

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

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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