CompletedNot Applicable

Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function

United States61 participantsStarted 2020-09-01

Plain-language summary

The investigators aim to assess the relationship between overweight/obesity and decreased cognitive function in adolescents. While this relationship has been seen in past literature, the causal mechanisms are still unclear. Thus, the present study will assess sleep and stigma as possible moderators. As sleep is related to both weight and cognitive abilities it may be an important factor in the relationship between these two variables. Further, people with overweight/obesity have higher risk for stigma experiences which may increase inflammation through chronic stress and elevated cortisol. Because inflammation is theorized to play a role in the relationship between elevated BMI and decreased cognitive function, stigma may be an important moderator. 60 adolescent participants will complete two sleep conditions (adequate and restricted) in a randomized order, each followed by a lab visit during which participants will complete a short cognitive battery. At these visits, participants will also be given a self serve breakfast with a variety of whole and processed food options to further evaluate the relationship between overweight/obesity, sleep, nutritional intake, and cognitive function.

Who can participate

Age range

14 Years – 19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adolescent ages 14-19 Exclusion Criteria: * age under 14 or over 19 * sleep disorder * use of medications which impact sleep * learning disorder * history of eating disorder * recent weight changes \>10 pounds in the last 1 month * current feeding/eating difficulties * scores on the food fussiness sub-scale of the Childhood Eating Behaviors Questionnaire above 4.5 (out of 5)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Objectively Measured Cognitive Function Composite Score After Sleep Restriction

Timeframe: Immediately after the sleep restricted intervention

Objectively Measured Cognitive Function Composite Score After Adequate Sleep

Timeframe: Immediately after the adequate sleep intervention

Objectively Measured Fluid Cognition Composite Score After Sleep Restriction

Timeframe: Immediately after the sleep restricted intervention

Objectively Measured Fluid Cognition Composite Score After Adequate Sleep

Timeframe: Immediately after the adequate sleep intervention

Objectively Measured Attention After Sleep Restriction

Timeframe: Immediately after the sleep restricted intervention

Objectively Measured Attention After Adequate Sleep

Timeframe: Immediately after the adequate sleep intervention

Objectively Measured Working Memory After Sleep Restriction

Trial details

NCT IDNCT04346433

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-10-01

View on ClinicalTrials.gov More Obesity, Childhood trials