Effects of Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects

Obesity Clinical Trial

Official title:

The Effects of a Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558801
• Other study ID #: FeelGood
• Status: Completed
• Phase: N/A
• Start date: October 12, 2020
• Est. completion date: October 31, 2022

Study information

• Verified date: November 2022
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the trial is to study the effect of a mobile application-based lifestyle change program on body weight loss in adult subjects with obesity. The main focus is to motivate and support beneficial lifestyle changes targeting long-term weight management. This study comprises two randomly assigned study arms: mobile application-based lifestyle change program and "waiting-list" control. The mobile application-based lifestyle change program consists of twice a week content for the first 6 months, continuing with less frequent contents for the following 6 months (the length of intervention 12 months). The "waiting-list" control group will receive mobile application-based lifestyle change program after 6 months followed by intervention for 12 months. The main aim is to demonstrate that the users of mobile application-based lifestyle change program lose more weight than controls at 6 month timepoint and weight loss is maintained for 18 months (6 months after the end of mobile application-based lifestyle change program use). Weight is measured and blood samples (lipids, glucose and metabolic syndrome measures) are collected at 0, 6, 12, and 18 months. The mobile application-based counselling contains aspects of cognitive behavior therapy and persuasive system design and consists of twice a week reminders, tasks, self-monitoring, and reflection. The main outcome is the decrease in body weight. Secondary outcomes are changes in eating behavior, psychological factors, components of metabolic syndrome (waist circumference, plasma lipid and glucose values, blood pressure), and calculated scores of metabolic condition and adiposity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 31, 2022
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index 30 to 40 kg/m2
• Ownership of a smartphone

Exclusion Criteria:

• Untreated hypothyroidism
• Oral glucocorticoid treatment
• Pregnancy or lactation
• No possibility to use mobile phone or tablet
• No knowledge of Finnish language
• Presumed lack of adherence to the study
• Participation in another ongoing weight management program
• Diagnosed or suspicion of cardiovascular disease causing restrictions to exercising
• Bariatric operation planned
• Usage of any anti-obesity drug

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Weight Loss

Intervention

Device:
• Mobile application-based lifestyle change program
Usage of the Mobile application-based lifestyle change program

Locations

Country	Name	City	State
Finland	Oulu University Hospital	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight		Baseline to 6 months
Secondary	Change in body weight		Baseline to 12 months
Secondary	Change in body weight		Baseline to 18 months
Secondary	Change in eating behavior		Baseline to 6 months
Secondary	Change in waist circumference		Baseline to 6 months
Secondary	Change in blood pressure		Baseline to 6 months
Secondary	Change in metabolic syndrome status		Baseline to 6 months