Clinical trial NCT04558801: Effects of Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects
Official title: The Effects of a Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2020-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline to 6 months
Secondary outcomes:
measure: Change in body weight
timeFrame: Baseline to 12 months
measure: Change in body weight
timeFrame: Baseline to 18 months
measure: Change in eating behavior
timeFrame: Baseline to 6 months
measure: Change in waist circumference
timeFrame: Baseline to 6 months
measure: Change in blood pressure
timeFrame: Baseline to 6 months
measure: Change in metabolic syndrome status
timeFrame: Baseline to 6 months
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: University of Oulu, Oulu University Hospital
name: Janne Hukkanen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: