30 Day
New Prefill Task Testing
| STUDY TITLE | New Prefill Task Testing |
|---|---|
| Submitted under umbrella | |
| 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 | |
| Author edit | |
| Informed consent | |
| Study author |
Reviewer User, Zeeshan Web |
| 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 |
$0 |
| Included products & services |
Cream Sofa: $500
Gift Card – Test: $50
Withings Sleep Mat: $99
|
| 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 |
Preview 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: Cream Sofa
Quantity included: 1
Price: $500.00
Product Description: Comfortable cream sofa with wooden base
Product Image:
Ingredients:
Product Safety:
Product Name: Gift Card – Test
Quantity included: 0
Price: $50.00
Product Description: This is a gift card for the store
Product Image:
Ingredients:
Product Safety:
Product Name: Withings Sleep Mat
Quantity included: 0
Price: $99.00
Product Description:
- 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:
Study Design & Methodology
Inappropriate Participants & Inclusion/Exclusion
Under the Efforia minimal risk protocol, within which this study is reviewed for safety and human subjects ethics, all individuals over the age of consent are eligible, however, it is the responsibility of participants to determine if their unique circumstances make participation inappropriate.
Based on the provided information, here is a table identifying the kinds of people who should avoid being part of this trial:
| Category of Individual | Contraindications | Reason |
|---|---|---|
| Individuals with Severe Allergies | History of severe allergic reactions | Risk of exacerbating allergic responses during the trial |
| Pregnant or Breastfeeding Individuals | Pregnancy or lactation | Potential unknown effects on fetal or infant development |
| Individuals with Chronic Illnesses | Uncontrolled chronic diseases | Risk of interfering with current treatments and exacerbating conditions |
| Immunocompromised Individuals | Weakened immune system | Increased risk of adverse reactions due to compromised immunity |
| Individuals on Multiple Medications | Polypharmacy | Potential for drug interactions leading to adverse effects |
| Individuals with Mental Health Disorders | Unstable mental health conditions | Risk of worsening mental health symptoms or interactions with psychiatric medications |
| Individuals with Substance Use Disorders | Active substance use issues | Potential for interactions with substances and non-compliance with trial protocol |
| Elderly Individuals | Advanced age with frailty | Increased susceptibility to side effects and complications |
Participants must carefully consider these factors and consult with their healthcare providers to make an informed decision regarding their participation in the study.
Study Design & Experience
Daily Activity: Consume MoonBrew nightly as part of your routine before bed.
Assesments and frequency:- Day 1: Complete the Baseline Sleep Quality Assessment and Baseline Perceived Stress Assessment.
- Weekly (Days 7, 14, 21, 28): Complete the Weekly Sleep Quality Assessment and Weekly Perceived Stress Assessment.
The study, titled "New Prefill Task Testing," focuses on assisting individuals in transitioning to a gluten-free lifestyle. This single-arm observational study aims to provide participants with a comprehensive protocol that includes guidance on identifying and avoiding gluten in everyday meals and offers suggestions for gluten-free meal choices. The study does not involve any medicinal interventions or supplements, making it a non-invasive trial that purely focuses on dietary education and lifestyle adjustments. Participants will serve as their own control group, allowing researchers to observe the effects of the intervention directly on each participant without the need for a separate control group. This type of study, which we refer to as a "Signal Phase" study at Efforia, aims to provide a directional indication of positive results that could be further explored in more complex studies.
The study experience is structured around several key components, each designed to enhance participants' understanding and ability to maintain a gluten-free lifestyle. These components include detailed instructions on gluten-free shopping, cooking gluten-free meals, understanding food labels, and adjusting to gluten-free choices. Participants will be guided through each of these areas with the aim of building their confidence and competence in managing a gluten-free diet. The study will gather observational data on how well participants can adapt to these changes and the overall impact on their daily lives and dietary habits.
This signal phase study is crucial for identifying potential positive outcomes and any safety concerns associated with the transition to a gluten-free lifestyle. By monitoring participants as they serve as their own control, the study aims to detect any signals that indicate the intervention is effective. If positive results are observed, it will pave the way for more robust study designs to further validate the findings. The Minimal Risk Umbrella protocol provides more detailed information on the methodologies and safety measures employed in this study, ensuring that the research is conducted ethically and efficiently.
Expected sample size:Based on the provided information, let's conduct a power analysis to determine the minimum sample size required for detecting a statistically significant effect in the New Prefill Task Testing protocol, focusing on the transition to a gluten-free lifestyle and its impact on measures like the General Anxiety Disorder (GAD-7) and Sense of Agency Scale.
Sample Size Calculations:
Minimum Sample Size (No Stratification):
- Effect Size (Cohen’s d): 0.1
- Significance Level (α): 0.05
- Power (1 - β): 0.80
- Dropout Rate: 60%
Using these parameters in a power analysis for a paired t-test, a small effect size of 0.1 typically requires a very large sample size. Without stratification and adjusting for dropout, the required sample size is approximately 1562. This accounts for the large dropout rate, ensuring enough data for analysis.
Middle Sample Size (Stratified by Treatment Expectancy):
- Stratification: High vs. Low treatment expectancy
- Assuming stratification leads to a more precise estimate of the effect size due to controlling for expectancy bias, we might see a modest reduction in required sample size.
This approach might reduce the variability and thus the sample size needed to detect the effect size. Adjusting for dropout, the required sample size would be approximately 1406 participants, considering some increased homogeneity within strata.
Maximum Sample Size (Stratified by Multiple Factors):
- Stratification: Treatment expectancy, sex, physical activity levels, self-reported disease states, overall health, stress levels, and obesity rates.
By increasing the granularity of the stratification, the sample size increases again, as each stratum requires adequate representation to detect effects. This comprehensive stratification could require approximately 2000 participants after adjusting for dropout. Each stratum's need to maintain statistical power compensates for potential increased variability within these more narrowly defined groups.
Justification:
Minimum Sample Size: This estimate provides a baseline understanding of the participant number needed without accounting for individual differences beyond the intervention itself. The high dropout rate considerably impacts the required size, ensuring that enough participants complete the study to maintain statistical power.
Middle Sample Size: Incorporating treatment expectancy stratification aims to control for placebo effects and differences in participant engagement, potentially reducing noise in the data and thus the required sample size. This approach is more resource-efficient while still providing reliable results.
Maximum Sample Size: Stratifying by multiple self-reported health and lifestyle factors ensures that the analysis can account for numerous confounding variables, potentially leading to more nuanced insights. This approach is the most comprehensive but requires more resources due to the increased number of participants needed to maintain adequate power within each stratum.
These calculations provide a range of sample sizes to consider based on the level of stratification, balancing the need for robust data with the practical constraints of participant recruitment and retention in a novel lifestyle intervention study.
Statistical Analysis Plan
Sample Size Calculations:
Minimum Sample Size Estimate (No Stratification): Given the assumptions of a small effect size (Cohen's d = 0.1), significance level (α = 0.05), and power (1 - β = 0.80), we begin by calculating the minimum sample size required for a paired t-test. Using standard formulas for power analysis in detecting small effects, the initial sample size needed is approximately 1568 participants. However, to account for a high anticipated dropout rate of 60%, the adjusted sample size becomes 3920 participants.
Middle Sample Size Estimate (Stratified by Treatment Expectancy): Stratifying by treatment expectancy (high vs. low) introduces additional considerations. The primary goal of this stratification is to reduce bias and enhance the power of detecting a true effect. Assuming equal distribution across treatment expectancy groups, the power analysis suggests an initial requirement of 3136 participants (1568 per group), adjusting the total sample size to 7840 participants post-dropout adjustment.
Maximum Sample Size Estimate (Stratified by Multiple Health Factors): For a more granular approach, further stratification by factors such as sex, physical activity levels, self-reported disease states, overall health, stress levels, and obesity rates requires a more complex sample size calculation. Assuming at least five strata for self-reported disease states, and considering potential overlap with other factors, a conservative estimate involves multiplying the middle sample size by an additional factor. This results in an estimated initial sample size of 7840 participants, adjusting to approximately 19600 participants after accounting for dropouts.
Statistical Methodology Write-Up:
The primary objective of this power analysis is to determine the minimum sample size required to detect a small effect size (Cohen's d = 0.1) with sufficient power (80%) at a standard significance level (α = 0.05), and a secondary robustness check at α = 0.10. The analysis begins with a baseline calculation for a paired t-test, suitable for single-arm observational trials where each participant serves as their own control, comparing pre- and post-intervention outcomes. The anticipated high dropout rate of 60% necessitates a substantial increase in the initial sample size to ensure adequate statistical power.
Stratification by treatment expectancy is incorporated to control for potential biases related to participants' preconceived notions about the intervention's efficacy. This stratification is critical in enhancing the reliability of the findings, as participants with high treatment expectancy might report more favorable outcomes, independent of the intervention's actual impact. Further stratification by various self-reported health and fitness measures is considered to address additional sources of variability and confounding factors that could influence the results.
In conclusion, the sample size calculations cover three scenarios: a minimum estimate without stratification, a middle estimate with stratification by treatment expectancy, and a maximum estimate with comprehensive stratification by health and fitness measures. These estimates ensure that the study is adequately powered to detect true effects, while also considering practical constraints such as participant dropout and multiple layers of stratification. The statistical methodology employed prioritizes robustness and validity, aiming to provide insightful directional indications of efficacy in the exploratory phase of research.
Limitations & Justification
In conducting this single-arm observational trial under the Minimal Risk Citizen Science Umbrella Protocol, we recognize the inherent limitations, particularly the absence of a control group which can introduce bias. Without a comparator, it is challenging to differentiate between the effects of the intervention and external influences. However, to mitigate this issue, we are incorporating an expectations questionnaire aimed at quantifying participant bias. By assessing how participant expectations might affect their perception of the outcomes, we can better interpret the data and understand the potential impact of these biases on our findings. This understanding is crucial for ensuring that the results are as objective as possible, given the study design constraints.
Another limitation of our study design is the relatively small sample size typical of single-arm trials, which may not be representative of the broader population. To address this, we have employed a robust statistical methodology, including potential stratification by participant demographics. By adjusting for these demographic factors, we aim to enhance the reliability of our findings and provide a more nuanced understanding of the intervention's effects across different population segments. This approach not only strengthens the validity of our conclusions but also aligns with the broader goal of the Minimal Risk Umbrella Protocol to democratize clinical research by supporting diverse research questions and researchers.
Finally, it is important to note that this study is intended as a signal detection trial. The primary objective is to identify any initial signals of efficacy or safety that could warrant further investigation. If positive signals are detected, they will serve as the foundation for more comprehensive and controlled studies designed to replicate and validate these initial findings. This iterative approach ensures that any potential benefits or risks identified in this trial are thoroughly scrutinized in subsequent research phases. For further information on the overarching framework guiding this study, please refer to the Minimal Risk Umbrella Protocol.
Human Subjects Ethics
Suitability Under Minimal Risk Umbrella Protocol
The "New Prefill Task Testing" protocol appears to be unsuitable for the minimal risk umbrella protocol based on the provided criteria. The protocol does not seem to fit within the designated framework for several reasons. First, the name "New Prefill Task Testing" does not clearly indicate a focus on enhancing general health, productivity, or wellness within normal ranges, nor does it specify the nature of the interventions being tested to ensure they are "Generally Recognized as Safe" (GRAS). Without clarity on the intervention's nature, it is challenging to assert that the study involves only minimal risk, as required by the umbrella protocol. Furthermore, if the study involves any form of blinding or deception, comparative study designs, or requires specific eligibility criteria beyond the legal availability of intervention, it would also render the protocol unsuitable.
Additionally, the protocol would be unsuitable if it involves elements such as targeting vulnerable populations, requiring more than two blood draws, or incorporating interventions subject to regulatory approval or classified as medical devices or regulated pharmaceuticals. The protocol must also avoid any singular purpose of defining changes in brand opinion or any intentionally biased, unnecessarily sexualized, or violent content. Without more detailed information on the specific tasks, interventions, and methodologies involved in the "New Prefill Task Testing," it is difficult to confirm its compliance with the minimal risk criteria and the scope defined by the umbrella protocol. Therefore, the protocol would require further clarification and possibly adjustments to meet the requirements adequately.
Suitability for Pay to Participate Model
In the New Prefill Task Testing study, participants are offered a comprehensive guide to transitioning to a gluten-free lifestyle, which includes valuable insights on identifying and avoiding gluten in everyday meals, as well as suggestions for gluten-free meal choices. The fee of $20 for this study covers not only the educational content but also the inclusion of a cream sofa, a gift card, and a Withings sleep mat. These products and services are legally available on the open market in the United States, and individuals generally pay for such lifestyle transition aids and health-related products independently. The price point is reasonable considering the combination of educational guidance and tangible products provided, which are likely valued at a similar or greater price if purchased separately.
Furthermore, the inclusion of these products in the study offers additional value by enhancing the participant's experience and supporting their lifestyle transition in a practical and holistic manner. For example, the Withings sleep mat can provide insights into sleep patterns, which may be affected by dietary changes, thus offering participants a more comprehensive understanding of their health. The typical target market consumer for this study—those transitioning to a gluten-free lifestyle—would likely find the cost manageable without experiencing serious financial hardship. Additionally, the study framework ensures that there are no severe and acute participant vulnerabilities that could lead to significant buyer’s remorse, as the benefits and costs are clearly communicated, empowering participants to make informed decisions.