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

Not Applicable

Completed

• Conditions: Obesity
• Interventions: Device: Mobile application-based lifestyle change program

• Registration Number: NCT04558801
• Lead Sponsor: University of Oulu

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-16
• Study First Posted: 2020-09-22
• Study Start: 2020-10-12
• Primary Completion: 2021-07-09
• Study Completion: 2022-10-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
The "waiting-list" control	Mobile application-based lifestyle change program	The "waiting-list" control arm will receive mobile application-based lifestyle change program after 6 months, following same principles as "Mobile application-based lifestyle change program"-arm, excluding follow-up period (6 months of "waiting list", 6 months of more intense and 6 months of less intense application use).
Mobile application-based lifestyle change program	Mobile application-based lifestyle change program	This arm receives the mobile application-based lifestyle change program at baseline. The mobile application-based lifestyle change program consists of twice a week content for the first 6 months, continuing with less frequent content for the following 6 months. The follow-up period is 6 months. 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.

Primary Outcome Measures

Name	Time	Method
Change in body weight	Baseline to 6 months

Secondary Outcome Measures

Name	Time	Method
Change in eating behavior	Baseline to 6 months
Change in body weight	Baseline to 18 months
Change in blood pressure	Baseline to 6 months
Change in waist circumference	Baseline to 6 months
Change in metabolic syndrome status	Baseline to 6 months

Trial Locations

Locations (1)

Oulu University Hospital; 🇫🇮 Oulu, Finland