Skip to main content
OpenTrials
Completed

NCT Number: NCT04558801

Effects of 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oulu University Hospital

Oulu, 90029 OYS, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile application-based lifestyle change program

Device

Usage of the Mobile application-based lifestyle change program

Primary outcomes

  1. Change in body weight

    Time frame: Baseline to 6 months

Secondary outcomes

  1. Change in body weight

    Time frame: Baseline to 12 months

  2. Change in body weight

    Time frame: Baseline to 18 months

  3. Change in eating behavior

    Time frame: Baseline to 6 months

  4. Change in waist circumference

    Time frame: Baseline to 6 months

  5. Change in blood pressure

    Time frame: Baseline to 6 months

  6. Change in metabolic syndrome status

    Time frame: Baseline to 6 months

Sponsors and collaborators

Lead sponsor

University of Oulu

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 22, 2020
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.