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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity

Intervention / Treatment
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* Device: Mobile application-based lifestyle change program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile application-based lifestyle change program<br>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. | Device: Mobile application-based lifestyle change program<br>* Usage of the Mobile application-based lifestyle change program<br>|
| Active Comparator: The waiting-list control<br>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). | Device: Mobile application-based lifestyle change program<br>* Usage of the Mobile application-based lifestyle change program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight |  | Baseline to 12 months | 
| Change in body weight |  | Baseline to 18 months | 
| Change in eating behavior |  | Baseline to 6 months | 
| Change in waist circumference |  | Baseline to 6 months | 
| Change in blood pressure |  | Baseline to 6 months | 
| Change in metabolic syndrome status |  | Baseline to 6 months |