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

NCT04558801 | Completed

• 1 other identifier: FeelGood
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in body weight

  Baseline to 6 months

Secondary Outcomes (6)

• 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

Study Arms (2)

Mobile application-based lifestyle change program

EXPERIMENTAL

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

The "waiting-list" control

ACTIVE COMPARATOR

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

Interventions

Mobile application-based lifestyle change program DEVICE

Usage of the Mobile application-based lifestyle change program

Mobile application-based lifestyle change program; The "waiting-list" control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index 30 to 40 kg/m2
• Ownership of a smartphone

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oulu: lead

Study Sites (1)

Oulu University Hospital

Oulu, 90029 OYS, Finland

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Janne Hukkanen, MD, PhD

  University of Oulu, Oulu University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 22, 2020
• Study Start: October 12, 2020
• Primary Completion: July 9, 2021
• Study Completion: October 31, 2022
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)