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

Primary Purpose

Obesity

Status
Recruiting
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
Mobile app
Sponsored by
Turku University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Turku University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Lean-overweight

Obese

Obese OSA

Arm Description

BMI 18.5 - 30 kg/m2

BMI > 30 kg/m2

OSAS patients with BMI > 30 kg/m2

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 9, 2021
Last Updated
June 13, 2022
Sponsor
Turku University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04850391
Brief Title
Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity
Acronym
ObeApp
Official Title
Interaction of Sleep, Diurnal Eating Pattern, Gut Microbiota, and Obesity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lean-overweight
Arm Type
Active Comparator
Arm Description
BMI 18.5 - 30 kg/m2
Arm Title
Obese
Arm Type
Active Comparator
Arm Description
BMI > 30 kg/m2
Arm Title
Obese OSA
Arm Type
Active Comparator
Arm Description
OSAS patients with BMI > 30 kg/m2
Intervention Type
Other
Intervention Name(s)
Mobile app
Intervention Description
To compare changes induced by the movile app intervention among the three study groups
Primary Outcome Measure Information:
Title
Weight
Description
Changes in weight
Time Frame
2 years
Title
Waist/Hip ratio
Description
Changes in Waist/Hip ratio
Time Frame
2 years
Title
Change in Blood Pressure
Description
Change in Blood Pressure
Time Frame
2 years
Title
GHbA1c
Description
Change in GHbA1c
Time Frame
2 years
Title
Gut microbiota
Description
Changes in gut microbiota (species, proportions of different species)
Time Frame
2 years
Title
Timing of eating
Description
Change in timing of eating
Time Frame
2 years
Title
Subjective sleep quality (Pittsburg Sleep Quality Index)
Description
Changes in subjective sleep quality
Time Frame
2 years
Title
Excessive daytime sleepiness (Epworth Sleepiness Scale)
Description
Change in excessive daytime sleepiness
Time Frame
2 years
Title
Mood (DEPS questionnaire)
Description
Changes in mood
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarja Saaresranta, MD, PhD
Phone
+35823130000
Email
tasaare@utu.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarja Saaresranta, MD, PhD
Organizational Affiliation
Turku University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarja Saaresranta, MD, PhD
Phone
+358 2 313 0000
Email
tarja.saaresranta@tyks.fi

12. IPD Sharing Statement

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

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