Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity

Conditions
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Obesity

Intervention / Treatment
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* Other: Mobile app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |