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

Primary Purpose

Obesity, Childhood, Overweight, Childhood

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restricted Sleep
Adequate Sleep
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity, Childhood focused on measuring sleep, stigma, cognitive function, nutrition

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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
  • current feeding/eating difficulties
  • scores on the food fussiness sub-scale of the Childhood Eating Behaviors Questionnaire above 25 (out of 30)

Sites / Locations

  • Sparks Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adolescents with Normal Weight

Adolescents with Overweight or Obesity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Objectively Measured Inhibition After Sleep Restriction
Measured using the Stroop Task
Objectively Measured Inhibition After Adequate Sleep
Measured using the Stroop Task
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.
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.

Secondary Outcome Measures

Subjectively Measured Behavior Regulation
Inhibition and self-monitoring measured using the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Subjectively Measured Emotional Regulation
Emotional control and shifting measured using the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Subjectively Measured Cognitive Regulation
Task completion, working memory, and planning/organizing measured using the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Subjectively Measured Global Executive Composite
Overall score on the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Food Consumption After Sleep Restriction
Participants will be given a self-serve breakfast of whole and processed foods. Foods will be weighed to the nearest 0.1g before and after the meal to determine the amount consumed. Overall macronutrient content of foods consumed will be recorded.
Food Consumption After Adequate Sleep
Participants will be given a self-serve breakfast of whole and processed foods. Foods will be weighed to the nearest 0.1g before and after the meal to determine the amount consumed. Overall macronutrient content of foods consumed will be recorded.
Stigma Experiences
Measured using the brief version of the Stigmatizing Situations Inventory. Composite scores range from 0-90, with higher scores indicating more frequent stigma experiences.

Full Information

First Posted
April 9, 2020
Last Updated
July 11, 2023
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT04346433
Brief Title
Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
Official Title
Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Obesity represents one of our nation's leading public health issues. In 2017, over 30% of U.S. high school students had either overweight (15.6%) or obesity (14.8%), and the average U.S. BMI continues to rise. Overall, this increasing trend is associated with earlier mortality and lower quality of life. In 2005 it was projected that if current U.S. weight trends continued, the average lifespan would decrease by about 9 months. Documented declines exceed this calculation, with rises in BMI relating to an estimated 11-month decrease in life expectancy in 2011. In adolescents specifically, this epidemic shares associations with many negative health outcomes including poorer sleep quality, impaired academic performance, and lower cognitive function. Thus, it is imperative that researchers work to understand the complex nature of this preventable disease and recognize its significant longitudinal health implications. One factor significantly related to overweight/obesity (OWOB) is decreased cognitive function. However, the causal nature of this relationship is unclear. It has been hypothesized that impaired cognitive function and poor inhibition could predict increased food consumption, thus contributing to the association between cognitive deficits and OWOB. Alternatively, it has been suggested that biological factors stemming from obesity (i.e. low grade inflammation, insulin resistance, low blood flow, and increased levels of cytokines and leptin) work to exacerbate preexisting cognitive impairments, or are perhaps fully responsible for the cognitive deficits seen in individuals with OWOB. Thus, further research is needed to clarify these relationships. Research regarding OWOB and cognitive function has left a critical gap in the literature by failing to consider the role of sleep within this relationship. Current evidence shows that more than 2/3 of adolescents fail to attain the recommended minimum of 8 hours of sleep during the week. However, a meta-analysis found that every added hour of sleep that adolescents do secure relates to a 9.0% decrease in obesity risk. In line with this finding, sleep restriction is associated with increased appetite, hunger, and poorer nutritional food choices. Sleep restriction has also been tied to impairments in cognitive function including decreased working memory and attention. Thus, it is possible that the relationship between OWOB and cognitive function in adolescents is influenced by sleep behaviors. Another important factor to consider in the relationship between OWOB and cognitive function is stigma. Weight stigma is a pervasive problem with multiple implications for physical health. For example, chronic low-grade inflammation represents a known correlate of chronic stress and stigmatization. This is significant as elevated inflammation also relates to OWOB and decreased cognitive function. Thus, the experience of weight related stigma may exacerbate existing inflammation in individuals with OWOB, further impairing cognitive function. The present study seeks to expand our knowledge of these complex relationships, exploring the associations between weight status, eating behavior, cognitive function, sleep, and stigma. To do this, the study will utilize data from 2 groups: adolescents with normal weight and adolescents with OWOB. Adolescents in each group will complete two sleep conditions in a randomized order: adequate and restricted. Each sleep condition will be followed by a self-serve breakfast and completion of a cognitive battery. Prior to completing the sleep conditions, adolescents will participate in a baseline appointment during which they will complete a questionnaire regarding weight related stigma experiences. The investigators propose that cognitive function and sleep restriction may relate to adolescent weight status through the following mechanisms: 1) elevated adiposity will predict greater impairments in cognitive functioning, poorer nutritional intake, and greater food consumption, 2) sleep restriction will result in impaired cognitive functioning, poorer nutritional intake, and increased food consumption in all adolescents, 3) sleep restriction in adolescents with elevated adiposity will result in the greatest cognitive impairments, poorest nutritional intake, and greatest food consumption, and 4) decreased cognitive function will be associated with poorer nutritional intake and greater food consumption in all adolescents. The investigators also propose that stigma experiences relate to adolescent weight status through the following mechanisms: 1) heightened stigma experiences will predict impairments in cognitive functioning in all adolescents and 2) elevated adiposity will relate to greater stigma experiences and subsequently higher cognitive impairments, resulting in the worst outcomes for assessments of cognitive function .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood, Overweight, Childhood
Keywords
sleep, stigma, cognitive function, nutrition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adolescents with Normal Weight
Arm Type
Experimental
Arm Description
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.
Arm Title
Adolescents with Overweight or Obesity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Restricted Sleep
Intervention Description
During the restricted sleep condition adolescents will sleep 4 hours ±1 hour (0100-0500). This condition will last 1 night.
Intervention Type
Behavioral
Intervention Name(s)
Adequate Sleep
Intervention Description
During the adequate sleep condition adolescents will sleep 9 hours ±1 hour (2100- 0800). This condition will last 1 night.
Primary Outcome Measure Information:
Title
Objectively Measured Cognitive Function Composite Score After Sleep Restriction
Description
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.
Time Frame
Immediately after the sleep restricted intervention
Title
Objectively Measured Cognitive Function Composite Score After Adequate Sleep
Description
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.
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Fluid Cognition Composite Score After Sleep Restriction
Description
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.
Time Frame
Immediately after the sleep restricted intervention
Title
Objectively Measured Fluid Cognition Composite Score After Adequate Sleep
Description
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.
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Attention After Sleep Restriction
Description
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.
Time Frame
Immediately after the sleep restricted intervention
Title
Objectively Measured Attention After Adequate Sleep
Description
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.
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Working Memory After Sleep Restriction
Description
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.
Time Frame
Immediately after the sleep restricted intervention
Title
Objectively Measured Working Memory After Adequate Sleep
Description
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.
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Processing Speed After Sleep Restriction
Description
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.
Time Frame
Immediately after the sleep restricted intervention
Title
Objectively Measured Processing Speed After Adequate Sleep
Description
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.
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Cognitive Flexibility After Sleep Restriction
Description
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.
Time Frame
Immediately after the sleep restricted intervention
Title
Objectively Measured Cognitive Flexibility After Adequate Sleep
Description
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.
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Inhibition After Sleep Restriction
Description
Measured using the Stroop Task
Time Frame
Immediately after the sleep restricted intervention
Title
Objectively Measured Inhibition After Adequate Sleep
Description
Measured using the Stroop Task
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Episodic Memory After Adequate Sleep
Description
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.
Time Frame
Immediately after the adequate sleep intervention
Title
Objectively Measured Episodic Memory After Restricted Sleep
Description
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.
Time Frame
Immediately after the restricted sleep intervention
Secondary Outcome Measure Information:
Title
Subjectively Measured Behavior Regulation
Description
Inhibition and self-monitoring measured using the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Time Frame
Baseline
Title
Subjectively Measured Emotional Regulation
Description
Emotional control and shifting measured using the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Time Frame
Baseline
Title
Subjectively Measured Cognitive Regulation
Description
Task completion, working memory, and planning/organizing measured using the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Time Frame
Baseline
Title
Subjectively Measured Global Executive Composite
Description
Overall score on the Behavior Rating Inventory of Executive Function. Scores are given as T-scores and percentiles with higher values indicating greater impairment.
Time Frame
Baseline
Title
Food Consumption After Sleep Restriction
Description
Participants will be given a self-serve breakfast of whole and processed foods. Foods will be weighed to the nearest 0.1g before and after the meal to determine the amount consumed. Overall macronutrient content of foods consumed will be recorded.
Time Frame
Immediately after the sleep restricted intervention
Title
Food Consumption After Adequate Sleep
Description
Participants will be given a self-serve breakfast of whole and processed foods. Foods will be weighed to the nearest 0.1g before and after the meal to determine the amount consumed. Overall macronutrient content of foods consumed will be recorded.
Time Frame
Immediately after the adequate sleep intervention
Title
Stigma Experiences
Description
Measured using the brief version of the Stigmatizing Situations Inventory. Composite scores range from 0-90, with higher scores indicating more frequent stigma experiences.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron D Fobian, PhD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Lindsay M Stager
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sparks Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function

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