120 Day

Chilipad for Sleep

STUDY TITLE Chilipad for Sleep
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

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Informed consent

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Study author

Matthew Amsden

Principal investigator

Matthew Amsden

Sub-Investigator for Adverse Events

Dr. Viral Patel

Description

This protocol promotes weight loss through a simple, accessible exercise: walking. Participants are encouraged to achieve a daily goal of 10,000 steps and maintain a daily caloric intake of 2,000 calories or below without the requirement for additional physical training or strict dietary restrictions. This approach leverages the natural, low-impact activity of walking to facilitate weight loss and improve overall fitness.

Participant engagement length

120 Days

Sponsor

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

Cost to participant

$1400

Included products & services
Metabolic Blood Test: $134
Cholesterol Blood Test: $129
Outcome measures

Quality of Life and Health Survey

Body Image and Self-Perception Survey

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”

Yes

Recruitment jurisdictions

United States, United Kingdom

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

Why I created this challenge:

In the whirlwind of extreme fitness trends and rigorous diets flooding social media and academic circles, walking emerges as a profoundly effective yet underappreciated tool for weight loss and fitness. Research underscores walking's benefits for metabolic and cardiovascular health, which align with anecdotal praises across platforms for its simplicity and accessibility. This challenge aims to scientifically validate the impact of walking on weight management and overall well-being, ensuring participants can embrace a sustainable health transformation.

My Objective for You:

Your goal in this challenge is simple yet impactful: integrate daily walking to meet a set step count while managing caloric intake. This approach is designed to improve your fitness and body image, grounded in scientific principles yet tailored to fit seamlessly into your lifestyle.

Aims & Objectives:

The primary aim is to assess how a structured walking regimen, combined with calorie management, contributes to weight loss and enhances self-perception. Secondly, the challenge seeks to understand the broader effects on participants' overall quality of life.

Significance & Impact:

This challenge stands to significantly alter public and academic perceptions of walking as a weight loss method. Expected outcomes include improved physical health metrics and enhanced body image, providing a foundation for long-term lifestyle changes. Limitations include variations in individual adherence and lifestyle factors that could influence results.

The Intervention

Included Products & Services

Product Name: Metabolic Blood Test

Quantity included: 0

Price: $134.00

Product Description: Efforia and Tasso present an innovative Metabolic Test, measuring cholesterol (HDL, Triglycerides, calculated LDL) and Hemoglobin A1C. Our small, non-invasive device, worn on the shoulder, gently collects a minimal blood sample. Slightly more expensive but far less daunting than traditional methods, it's ideal for those uncomfortable with needles. Just mail it back in the provided envelope for lab analysis. Convenient, efficient, and comfortable.

Product Image:

Ingredients:

Product Safety:

Product Name: Cholesterol Blood Test

Quantity included: 0

Price: $129.00

Product Description: Efforia collaborates with Tasso to offer a blood collection kit for cholesterol testing, including HDL, Triglycerides, and calculated LDL. It is pain-free device, attached to the shoulder, seamlessly collects a small blood sample. While slightly more expensive, it's far easier than the finger prick test and it's perfect for the needle-averse. Simply return it in the included pre-paid envelope for lab analysis. Easy, and stress free.

Product Image:

Ingredients:

Product Safety:

Study Design & Methodology

Inappropriate Participants & Inclusion/Exclusion

Study Design & Experience

Statistical Analysis Plan

Limitations & Justification

Human Subjects Ethics

Suitability Under Minimal Risk Umbrella Protocol

Suitability for Pay to Participate Model

Human Subjects Protection Questionnaire

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