ObesityObeAppNCT04850391
Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity
A study testing Mobile app in people with Obesity and Obesity & Overweight, run by Turku University Hospital at 1 site in Finland.
Trial summary
The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Obesity & Overweight
- What is being tested?
- Mobile app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteFinland
- Study dates
- 1 Oct 2021to 21 Oct 2024
- 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
- Community dwelling 18 - 65 year old adults
- BMI 18.5 - 30 kg/m2 (n = 40, M:F = 1:1)
- BMI > 30 kg/m2 (n = 40, M:F = 1:1)
- OSAS patients with BMI > 30 kg/m2 using nasal continuous positive airway pressure (CPAP) treatment on an average > 4 h/d (n = 40, M:F = 1:1).
Who cannot join
- Antimicrobial treatment within 3 months prior the baseline visit
- Inflammatory bowel diseases
Trial locations and contacts
1 site in 1 country.
About this study
The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.
Read the detailed description
The data are fragmented and studies are focusing on interactions of sleep and obesity, eating pattern and obesity, or gut microbiota and obesity, but not the cross-talk of all these factors in the same individual or population. Therefore, we need a multifactorial approach to get a more deep insight on the obesity and weight regulation. Further, novel cost-effective tools to advance lifestyle changes are needed. Emerging evidence suggests that novel countermeasures, such as modulation of the timing of food intake, may be effective strategies in weight control and prevention of obesity. The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.
- Conditions
- Obesity, Obesity & Overweight
- Being tested
- Mobile app
- Keywords
- obesity, eating window, time-restricted eating, sleep, glucose balance
- Medical subject headings
- Obesity, Overweight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile appOther
To compare changes induced by the movile app intervention among the three study groups
| Study group | Role | What they receive |
|---|---|---|
| Lean-overweight | Active comparator | BMI 18.5 - 30 kg/m2 Receives: Other: Mobile app |
| Obese | Active comparator | BMI > 30 kg/m2 Receives: Other: Mobile app |
| Obese OSA | Active comparator | OSAS patients with BMI > 30 kg/m2 Receives: Other: Mobile app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
Changes in weight
Measured: 2 years
Waist/Hip ratio
Changes in Waist/Hip ratio
Measured: 2 years
Change in Blood Pressure
Change in Blood Pressure
Measured: 2 years
GHbA1c
Change in GHbA1c
Measured: 2 years
Gut microbiota
Changes in gut microbiota (species, proportions of different species)
Measured: 2 years
Timing of eating
Change in timing of eating
Measured: 2 years
Subjective sleep quality (Pittsburg Sleep Quality Index)
Changes in subjective sleep quality
Measured: 2 years
Excessive daytime sleepiness (Epworth Sleepiness Scale)
Change in excessive daytime sleepiness
Measured: 2 years
Mood (DEPS questionnaire)
Changes in mood
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Oct 2021
- Primary completion21 Oct 2024
- Study completion21 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Helsinki, University of Turku
- Responsible party
- Principal investigator, Tarja Saaresranta, Turku University Hospital
- Investigators
- Tarja Saaresranta, MD, PhD, Principal investigator, Turku University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850391
- Sponsor's protocol ID
- ObeApp
- Acronym
- ObeApp
- Status last verified
- Dec 2025
- First submitted
- 9 Apr 2021
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity
- ClinicalTrials.gov ID
- NCT04850391
- Acronym / sponsor ID
- ObeApp / ObeApp
- Conditions
- Obesity, Obesity & Overweight
- Keywords
- obesity, eating window, time-restricted eating, sleep, glucose balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Helsinki, University of Turku
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 21 Oct 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 20 Apr 2021 (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 goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.
Detailed description
The data are fragmented and studies are focusing on interactions of sleep and obesity, eating pattern and obesity, or gut microbiota and obesity, but not the cross-talk of all these factors in the same individual or population. Therefore, we need a multifactorial approach to get a more deep insight on the obesity and weight regulation. Further, novel cost-effective tools to advance lifestyle changes are needed. Emerging evidence suggests that novel countermeasures, such as modulation of the timing of food intake, may be effective strategies in weight control and prevention of obesity. The goals of the proposed study are 1) to provide scientific basis for the relationship between subjective sleep quality, diurnal eating pattern, gut microbiome, and obesity, 2) to develop and test a pragmatic, cost-effective new tool to advance lifestyle changes using E-health approach, and 3) to compare differences in subjective sleep quality, diurnal eating pattern and gut microbiome at baseline 4) to compare changes induced by the E-health intervention among the three study groups and participants with different work schedules.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lean-overweight | Active comparator | Other: Mobile appBMI 18.5 - 30 kg/m2 |
| Obese | Active comparator | Other: Mobile appBMI > 30 kg/m2 |
| Obese OSA | Active comparator | Other: Mobile appOSAS patients with BMI > 30 kg/m2 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Community dwelling 18 - 65 year old adults
- BMI 18.5 - 30 kg/m2 (n = 40, M:F = 1:1)
- BMI > 30 kg/m2 (n = 40, M:F = 1:1)
- OSAS patients with BMI > 30 kg/m2 using nasal continuous positive airway pressure (CPAP) treatment on an average > 4 h/d (n = 40, M:F = 1:1).
Key exclusion criteria (2 listed)
- Antimicrobial treatment within 3 months prior the baseline visit
- Inflammatory bowel diseases
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 appTo compare changes induced by the movile app intervention among the three study groups | Other | Lean-overweight, Obese, Obese OSA |
Primary outcome
Weight
Time frame: 2 years
Changes in weight
Waist/Hip ratio
Time frame: 2 years
Changes in Waist/Hip ratio
Change in Blood Pressure
Time frame: 2 years
Change in Blood Pressure
GHbA1c
Time frame: 2 years
Change in GHbA1c
Gut microbiota
Time frame: 2 years
Changes in gut microbiota (species, proportions of different species)
Timing of eating
Time frame: 2 years
Change in timing of eating
Subjective sleep quality (Pittsburg Sleep Quality Index)
Time frame: 2 years
Changes in subjective sleep quality
Excessive daytime sleepiness (Epworth Sleepiness Scale)
Time frame: 2 years
Change in excessive daytime sleepiness
Mood (DEPS questionnaire)
Time frame: 2 years
Changes in mood
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 29 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Tarja Saaresranta, MD, PhD principal investigator
Turku 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 app in people with Obesity and Obesity & Overweight, run by Turku University Hospital 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 4 inclusion and 2 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 29 Dec 2025. 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?
Weight (time frame: 2 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2025.