NCT05728983

Brief Summary

This study administers two prescribed sleep levels, each lasting one week, that participants will complete in their at-home environment. One week is a well-rested (8-9 hrs/night attempted sleep) and another is a sleep-restricted (5-6 hrs/night attempted sleep) condition. In between these two conditions is an ad lib sleep week. At the end of each treatment week, the participants come to a laboratory session to go through a series of decision making tasks. Participants also track dietary intake through the 3-week protocol using the ASA24 website. This study was fully preregistered on the open science framework (OSF) has has registration DOI at https://doi.org/10.17605/OSF.IO/NSPRK

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

1.6 years

First QC Date

January 23, 2023

Last Update Submit

February 6, 2023

Conditions

Outcome Measures

Primary Outcomes (9)

  • Food-Image based go no-go task:

    This task is validated in the literature and available in Inquisit programmed form. It assesses inhibitory control in food related image selection (go) or non-selection (no-go) as compared to non-food related images

    3 weeks

  • Food-image based Approach Avoidance task

    This is a validated task available in Inquisit programmed form and it assess automatic processing to compare one's tendency to approach (pull image towards oneself on computer screen) or avoid (push image away from oneself on computer screen) images reflecting healthier versus less healthy foods

    3 weeks

  • Food Choice Task

    This task gives participants a short time span (e.g., 10 seconds) to select a set of food images to place in one's onscreen cart. Images includes healthier and unhealthy items.

    3 weeks

  • Food preference (ratings) task

    This just asks individual to report on a 0-100 scale how much they like various foods based on a displayed image of each (with higher numbers meaning the participant likes the item more)

    3 weeks

  • Delay-discounting monetary choice task

    This validated task asks one's preference of monetary amounts received today versus larger amounts received at some future point (e.g., 7 days, or 85 days later). Actual choices are paid out for a randomly selected subset of participants on a randomly selected trial (different trials vary the size of the monetary difference and the number of delays for the delayed reward).

    3 weeks

  • Food information based confirmation bias task

    This task assesses one's tendency to consider arguments regarding the healthiness or tastiness of food as more or less strong based on whether that participants dominant food ideology favors the consideration of healthiness or tastiness of food. The investigators have pilot tested and published a paper on this task.

    3 weeks

  • Snack/drink auction task

    In this task, participants are given a snack and a beverage as part of a decision session and allowed to bid on how much they would pay (or need to be paid) to exchange their snack or drink for a different snack or drink. Various combinations of snack auctions and drink auctions are considered in order to compare willingness to pay for healthier or less healthy snacks or drinks)

    3 weeks

  • Story retelling task

    This validated task presents participants with a short story that they are asked to retell so that we can assess preservation of key story details.

    3 weeks

  • Dietary intakes

    These data are gathered from daily dietary intakes input by participants on the ASA24 dietary recall website, which allows for separation of outcomes by various macronutrients.

    3 weeks

Secondary Outcomes (3)

  • Psychomotor vigilance task

    3 weeks

  • Karolinska sleepiness scale

    3 weeks

  • Objective Sleep duration

    3 weeks

Other Outcomes (4)

  • BMI

    1 day

  • Emotional Eating Scale

    1 day

  • Current Future self scale

    3 weeks

  • +1 more other outcomes

Study Arms (2)

Treatment group

EXPERIMENTAL

Participants randomly assigned to the treatment group arm experience both a well-rested and sleep-restricted week during the study

Other: Sleep levels

Control group

PLACEBO COMPARATOR

Participants randomly assigned to the treatment group arm experience two well-rested weeks during the study (and they still have an ad lib sleep week in between the two well-rested weeks)

Other: Sleep levels

Interventions

Sleep levels are what the experimenter prescribes to participants in the study.

Control groupTreatment group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years of age

You may not qualify if:

  • at risk of major depressive or anxiety disorder (from validated screener), self-reported or suspected sleep disorder, extreme diurnal preference type (from validated screener)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University

Boone, North Carolina, 28608, United States

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

February 15, 2023

Study Start

September 2, 2021

Primary Completion

April 1, 2023

Study Completion

October 1, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

No identifiable data are shared with other researchers

Locations