ObesityNCT04558801
Effects of Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects
A study testing Mobile application-based lifestyle change program in people with Obesity, run by University of Oulu at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Mobile application-based lifestyle change program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- 12 Oct 2020to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index 30 to 40 kg/m2
- Ownership of a smartphone
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Mobile application-based lifestyle change program
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application-based lifestyle change programDevice
Usage of the Mobile application-based lifestyle change program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Device: Mobile application-based lifestyle change program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Measured: Baseline to 6 months
Secondary outcomes (6)
Change in body weight
Measured: Baseline to 12 months
Change in body weight
Measured: Baseline to 18 months
Change in eating behavior
Measured: Baseline to 6 months
Change in waist circumference
Measured: Baseline to 6 months
Change in blood pressure
Measured: Baseline to 6 months
Change in metabolic syndrome status
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2020
- Study start12 Oct 2020
- Primary completion9 Jul 2021
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Janne Hukkanen, University of Oulu
- Investigators
- Janne Hukkanen, MD, PhD, Principal investigator, University of Oulu, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04558801
- Sponsor's protocol ID
- FeelGood
- Status last verified
- Nov 2022
- First submitted
- 16 Sep 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
PubMed 41744113
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Mobile Application-based Lifestyle Counselling on Body Weight Loss in Obese Subjects
- ClinicalTrials.gov ID
- NCT04558801
- Acronym / sponsor ID
- FeelGood
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Study start
- 12 Oct 2020 (actual)
- Primary completion
- 9 Jul 2021 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 22 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile application-based lifestyle change program | Experimental | Device: Mobile application-based lifestyle change programThis 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 | Active comparator | Device: Mobile application-based lifestyle change programThe "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). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Body mass index 30 to 40 kg/m2
- Ownership of a smartphone
Key exclusion criteria (10 listed)
- Untreated hypothyroidism
- Oral glucocorticoid treatment
- Pregnancy or lactation
- No possibility to use mobile phone or tablet
- No knowledge of Finnish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile application-based lifestyle change programUsage of the Mobile application-based lifestyle change program | Device | Mobile application-based lifestyle change program, The "waiting-list" control |
Primary outcome
Change in body weight
Time frame: Baseline to 6 months
6 secondary outcomes
Change in body weight
Time frame: Baseline to 12 months
Change in body weight
Time frame: Baseline to 18 months
Change in eating behavior
Time frame: Baseline to 6 months
Change in waist circumference
Time frame: Baseline to 6 months
Change in blood pressure
Time frame: Baseline to 6 months
Change in metabolic syndrome status
Time frame: Baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Derived from this study: PubMed 41744113Rahunen R, Merikallio H, Rinne V, Savolainen MJ, Hukkanen J. Hypertension in Overweight and Obesity: Sex-Specific Role of 4beta-Hydroxycholesterol. J Am Heart Assoc. 2026 Mar 3;15(5):e043913. doi: 10.1161/JAHA.125.043913. Epub 2026 Feb 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne Hukkanen, MD, PhD principal investigator
University of Oulu, Oulu University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application-based lifestyle change program in people with Obesity, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04558801, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.