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

NCT04346433 | Completed

• 1 other identifier: TBD2020
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity, Childhood; Overweight, Childhood

Keywords

sleep; stigma; cognitive function; nutrition

Outcome Measures

Primary Outcomes (16)

• Objectively Measured Cognitive Function Composite Score After Sleep Restriction

  Overall cognitive function score measured using the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the sleep restricted intervention

• Objectively Measured Cognitive Function Composite Score After Adequate Sleep

  Overall cognitive function score measured using the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the adequate sleep intervention

• Objectively Measured Fluid Cognition Composite Score After Sleep Restriction

  Executive function, attention, processing speed, and episodic and working memory measured using the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the sleep restricted intervention

• Objectively Measured Fluid Cognition Composite Score After Adequate Sleep

  Executive function, attention, processing speed, and episodic and working memory measured using the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the adequate sleep intervention

• Objectively Measured Attention After Sleep Restriction

  Measured using the Flanker Inhibitory Control and Attention subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the sleep restricted intervention

• Objectively Measured Attention After Adequate Sleep

  Measured using the Flanker Inhibitory Control and Attention subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the adequate sleep intervention

• Objectively Measured Working Memory After Sleep Restriction

  Measured using the List Sorting Working Memory subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the sleep restricted intervention

• Objectively Measured Working Memory After Adequate Sleep

  Measured using the List Sorting Working Memory subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the adequate sleep intervention

• Objectively Measured Processing Speed After Sleep Restriction

  Measured using the Pattern Comparison Processing Speed subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the sleep restricted intervention

• Objectively Measured Processing Speed After Adequate Sleep

  Measured using the Pattern Comparison Processing Speed subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the adequate sleep intervention

• Objectively Measured Cognitive Flexibility After Sleep Restriction

  Measured using the Dimensional Change Card Sort subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the sleep restricted intervention

• Objectively Measured Cognitive Flexibility After Adequate Sleep

  Measured using the Dimensional Change Card Sort subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the adequate sleep intervention

• Objectively Measured Inhibition After Sleep Restriction

  Measured using the Stroop Task

  Immediately after the sleep restricted intervention

• Objectively Measured Inhibition After Adequate Sleep

  Measured using the Stroop Task

  Immediately after the adequate sleep intervention

• Objectively Measured Episodic Memory After Adequate Sleep

  Measured using the Picture Sequence Memory subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the adequate sleep intervention

• Objectively Measured Episodic Memory After Restricted Sleep

  Measured using the Picture Sequence Memory subtest of the National Institute of Health Toolbox Cognition Battery. Scores reported as standard scores with an average normative score of 100 and standard deviation of 15. Higher standard scores indicate better performance.

  Immediately after the restricted sleep intervention

Secondary Outcomes (7)

• Subjectively Measured Behavior Regulation

  Baseline

• Subjectively Measured Emotional Regulation

  Baseline

• Subjectively Measured Cognitive Regulation

  Baseline

• Subjectively Measured Global Executive Composite

  Baseline

• Food Consumption After Sleep Restriction

  Immediately after the sleep restricted intervention

Study Arms (2)

Adolescents with Normal Weight

EXPERIMENTAL

This group will be comprised of 30 adolescents with normal weight (BMI equal to or greater than the 5th percentile but less than the 85th percentile). Participants will be asked to engage in the sleep manipulation intervention.

Behavioral: Restricted Sleep; Behavioral: Adequate Sleep

Adolescents with Overweight or Obesity

EXPERIMENTAL

This group will be comprised of 30 adolescents with overweight or obesity (BMI equal to or above the 85th percentile). Participants will be asked to engage in the sleep manipulation intervention.

Behavioral: Restricted Sleep; Behavioral: Adequate Sleep

Interventions

Restricted Sleep BEHAVIORAL

During the restricted sleep condition adolescents will sleep 4 hours ±1 hour (0100-0500). This condition will last 1 night.

Adolescents with Normal Weight; Adolescents with Overweight or Obesity

Adequate Sleep BEHAVIORAL

During the adequate sleep condition adolescents will sleep 9 hours ±1 hour (2100- 0800). This condition will last 1 night.

Adolescents with Normal Weight; Adolescents with Overweight or Obesity

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescent ages 14-19

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Sparks Center

Birmingham, Alabama, 35209, United States

Location

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MeSH Terms

Conditions

Pediatric Obesity; Social Stigma

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Social Behavior; Behavior

Study Officials

• Aaron D Fobian, PhD

  The University of Alabama at Birmingham

  STUDY DIRECTOR

• Lindsay M Stager

  The University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Graduate Research Assistant

Study Record Dates

• First Submitted: April 9, 2020
• First Posted: April 15, 2020
• Study Start: September 1, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 13, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)