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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Device: Mobile application-based lifestyle change program

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland, 90029 OYS
    • Oulu University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Mobile application-based lifestyle change program; Usage of the Mobile application-based lifestyle change program
ACTIVE_COMPARATOR: 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).	Device: Mobile application-based lifestyle change program; Usage of the Mobile application-based lifestyle change program

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in body weight	Baseline to 12 months
Change in blood pressure	Baseline to 6 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 metabolic syndrome status	Baseline to 6 months

Collaborators and Investigators

• Sponsor: University of Oulu

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 12, 2020
• Primary Completion (ACTUAL): July 9, 2021
• Study Completion (ACTUAL): October 31, 2022

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (ACTUAL): September 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Body Weight
• Other Study ID Numbers: FeelGood

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No