Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity (ObeApp)

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 Overview

• Status: Completed
• Conditions: Obesity; Obesity & Overweight
• Intervention / Treatment: Other: Mobile app

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 Type: Interventional
• Enrollment (Actual): 133
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Turku, Finland, 20521
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Antimicrobial treatment within 3 months prior the baseline visit
• Inflammatory bowel diseases

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lean-overweight; BMI 18.5 - 30 kg/m2	Other: Mobile app; To compare changes induced by the movile app intervention among the three study groups
Active Comparator: Obese; BMI > 30 kg/m2	Other: Mobile app; To compare changes induced by the movile app intervention among the three study groups
Active Comparator: Obese OSA; OSAS patients with BMI > 30 kg/m2	Other: Mobile app; To compare changes induced by the movile app intervention among the three study groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Changes in weight	2 years
Waist/Hip ratio	Changes in Waist/Hip ratio	2 years
Change in Blood Pressure	Change in Blood Pressure	2 years
GHbA1c	Change in GHbA1c	2 years
Gut microbiota	Changes in gut microbiota (species, proportions of different species)	2 years
Timing of eating	Change in timing of eating	2 years
Subjective sleep quality (Pittsburg Sleep Quality Index)	Changes in subjective sleep quality	2 years
Excessive daytime sleepiness (Epworth Sleepiness Scale)	Change in excessive daytime sleepiness	2 years
Mood (DEPS questionnaire)	Changes in mood	2 years

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: University of Turku; University of Helsinki
• Investigators: Principal Investigator: Tarja Saaresranta, MD, PhD, Turku University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): October 21, 2024
• Study Completion (Actual): October 21, 2024

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: sleep; obesity; time-restricted eating; eating window; glucose balance
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Behavior; Nutritional and Metabolic Diseases; Signs and Symptoms; Feeding Behavior; Fasting; Overweight; Obesity; Intermittent Fasting
• Other Study ID Numbers: ObeApp

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No