30 Day

Gluten-Free Lifestyle Transition

STUDY TITLE Gluten-Free Lifestyle Transition
Submitted under umbrella

Minimal Risk Citizen Science Umbrella Protocol

Date submitted

-

End date

There is no pre-specified end date and sub-studies remain open long-term.

Language

English

Efforia AI IRB approval recommendation

Lorem Ipsum

Recruitment page preview

Preview

Author edit

Edit

Informed consent

Review

Study author

Ivan Fedkiv

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol is designed to assist users in transitioning to a gluten-free lifestyle. It includes guidance on identifying and avoiding gluten in everyday meals, and suggestions for gluten-free meal choices. It does not involve any medicinal interventions or supplements.

Participant engagement length

30 Days

Sponsor

This study is made possible by your payment to cover all supplies and expenses required to participate.

Cost to participant

$20

Included products & services
Withings Sleep Mat: $99
Withings Scale: $59
Outcome measures

General Anxiety Disorder (GAD-7)

Sense of Agency Scale

Methodology

Single Arm longitudinal where participants act as their own control

Basic or advanced dissemination plan

Basic

Deviation from recruitment approach

No

Deviation from statistical approach

No

Will study include “more about you questions”

No

Clinicaltrials.Gov

Yes

Committment to list findings on clinicaltrials.Gov

Yes

This document is prepared with the assistance of AI, but is reviewed by a human.

Rational & Study Design

The Intervention

Included Products & Services

Product Name: Withings Sleep Mat

Quantity included: 2

Price: $99.00

Product Description:

For the first time, a home sleep tracker provides sleep-lab insights with the benefit of convenience. There is nothing to wear thanks to an unobtrusive mat designed for one-time setup under the mattress. Withings Sleep concentrates the world’s most advanced sensors and technology to analyze your sleep and detect breathing disturbances. With precise & understandable insights in the Health Mate app, anyone can discover how to achieve better sleep quality for better health.
  • NOTHING TO WEAR - Easy one-time setup under the mattress makes Withings Sleep fit effortlessly into your life. Plus, with automatic sync via Wi-Fi, there’s nothing you need to do but sleep, and you’ll wake to find all data in the app.
  • ADVANCED SLEEP TRACKING - Get a lab-level & in-depth analysis of your night with sleep cycles (deep, light & REM) and their duration, plus sleep duration and interruptions.
  • SLEEP SCORE - Get an interpretation of how restorative the night was and learn what you can do to improve it with the Sleep Score. It breaks down your night in 6 meaningful indicators with color-coded feedback to clearly identify the dimension of your sleep that can be improved.
  • BREATHING DISTURBANCES DETECTION - Withings Sleep monitors the intensity of breathing disturbances, thanks to an algorithm that analyzes interruptions in breathing patterns that occur during the night. Get to know the intensity of these pauses to learn about the impact they have on your nights.
  • SNORE DETECTION - Track the number of snoring episodes and their duration. In the app, learn more about snoring patterns and what impacts them.
  • CONTINUOUS HEART RATE TRACKING - Withings Sleep measures your heart rate while sleeping, an indicator reflecting whether enough time is spent in deep sleep and a powerful marker of how your lifestyle impacts your heart health. Know how to interpret your HR with color-coded feedback and get tips to improve it.
  • HOME AUTOMATION SCENARIOS - Control lights, temperature, and other smart home devices just by getting into and out of bed via IFTTT integration.
  • DEVELOPED WITH EXPERTS, BACKED BY SCIENCE - Developed in collaboration with sleep physicians and included in clinical studies.

Product Image:

Ingredients:

Product Safety:

Product Name: Withings Scale

Quantity included: 1

Price: $59.00

Product Description:

Just step on this advanced clinically tested smart scale for instant feedback and highly accurate weight & weight trends, BMI, full body composition (body fat and water percentage, plus muscle and bone mass), and much more. Every weigh-in appears in the Health Mate app automatically, via Wi-Fi or Bluetooth sync. And unlike many smart scales, with Wi-Fi sync, you don’t have to have your phone with you when you weigh-in to synchronize your data.

Product Image:

Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Lorem Ipsum 3

Study Design & Experience

Lorem Ipsum is a dummy content

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Lorem Ipsum 5

Suitability for Pay to Participate Model

Lorem Ipsum 6

Human Subjects Protection Questionnaire

Lorem Ipsum 7