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

NCT ID: NCT04558801

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-12
• Study Completion Date: 2022-10-31

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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Mobile application-based lifestyle change program

Intervention Type: DEVICE

Usage of the Mobile application-based lifestyle change program

The "waiting-list" control

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).

Group Type: ACTIVE_COMPARATOR

Mobile application-based lifestyle change program

Intervention Type: DEVICE

Usage of the Mobile application-based lifestyle change program

Interventions

Mobile application-based lifestyle change program

Usage of the Mobile application-based lifestyle change program

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oulu

OTHER

Sponsor Role: lead

Responsible Party

Janne Hukkanen

Professor of Internal Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Janne Hukkanen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu, Oulu University Hospital

Locations

Oulu University Hospital

Oulu, , Finland

Countries

Finland

Other Identifiers

FeelGood

Identifier Type: -

Identifier Source: org_study_id