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

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Mobile application-based lifestyle change program
Sponsored by
University of Oulu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oulu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile application-based lifestyle change program

The "waiting-list" control

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Change in body weight

Secondary Outcome Measures

Change in body weight
Change in body weight
Change in eating behavior
Change in waist circumference
Change in blood pressure
Change in metabolic syndrome status

Full Information

First Posted
September 16, 2020
Last Updated
November 1, 2022
Sponsor
University of Oulu
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1. Study Identification

Unique Protocol Identification Number
NCT04558801
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
October 12, 2020 (Actual)
Primary Completion Date
July 9, 2021 (Actual)
Study Completion Date
October 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oulu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application-based lifestyle change program
Arm Type
Experimental
Arm Description
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.
Arm Title
The "waiting-list" control
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Mobile application-based lifestyle change program
Intervention Description
Usage of the Mobile application-based lifestyle change program
Primary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline to 6 months
Secondary Outcome Measure Information:
Title
Change in body weight
Time Frame
Baseline to 12 months
Title
Change in body weight
Time Frame
Baseline to 18 months
Title
Change in eating behavior
Time Frame
Baseline to 6 months
Title
Change in waist circumference
Time Frame
Baseline to 6 months
Title
Change in blood pressure
Time Frame
Baseline to 6 months
Title
Change in metabolic syndrome status
Time Frame
Baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janne Hukkanen, MD, PhD
Organizational Affiliation
University of Oulu, Oulu University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029 OYS
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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