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

Turku University Hospital (TYKS)

Status: Completed

Conditions: Obesity & Overweight; Obesity

Treatments: Other: Mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT04850391

ObeApp

Details and patient eligibility

About

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.

Full 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.

Enrollment: 133 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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133 participants in 3 patient groups

Lean-overweight

Active Comparator group

Description:

BMI 18.5 - 30 kg/m2

Treatment:

Other: Mobile app

Obese

Active Comparator group

Description:

BMI \> 30 kg/m2

Treatment:

Other: Mobile app

Obese OSA

Active Comparator group

Description:

OSAS patients with BMI \> 30 kg/m2

Treatment:

Other: Mobile app