Obesity, ChildhoodNCT04346433
Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
A study testing Restricted Sleep and Adequate Sleep in people with Obesity, Childhood and Overweight, Childhood, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Overweight, Childhood
- What is being tested?
- Restricted Sleep and Adequate Sleep
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescent ages 14-19
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 .
- Conditions
- Obesity, Childhood, Overweight, Childhood
- Being tested
- Restricted Sleep, Adequate Sleep
- Keywords
- sleep, stigma, cognitive function, nutrition
- Medical subject headings
- Pediatric Obesity, Social Stigma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Restricted SleepBehavioural
During the restricted sleep condition adolescents will sleep 4 hours ±1 hour (0100-0500). This condition will last 1 night.
Adequate SleepBehavioural
During the adequate sleep condition adolescents will sleep 9 hours ±1 hour (2100- 0800). This condition will last 1 night.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Restricted Sleep; Behavioral: Adequate Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately after the adequate sleep intervention
Objectively Measured Inhibition After Sleep Restriction
Measured using the Stroop Task
Measured: Immediately after the sleep restricted intervention
Objectively Measured Inhibition After Adequate Sleep
Measured using the Stroop Task
Measured: 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.
Measured: 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.
Measured: Immediately after the restricted sleep intervention
Secondary outcomes (7)
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Immediately after the sleep restricted intervention
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.
Measured: Immediately after the adequate sleep intervention
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Sep 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lindsay M Stager, University of Alabama at Birmingham
- Investigators
- Aaron D Fobian, PhD, Study director, The University of Alabama at BirminghamLindsay M Stager, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346433
- Sponsor's protocol ID
- TBD2020
- Status last verified
- Jul 2023
- First submitted
- 9 Apr 2020
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, Robinson TN, Scott BJ, St Jeor S, Williams CL. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005 Apr 19;111(15):1999-2012. doi: 10.1161/01.CIR.0000161369.71722.10.
PubMed 15837955Liang J, Matheson BE, Kaye WH, Boutelle KN. Neurocognitive correlates of obesity and obesity-related behaviors in children and adolescents. Int J Obes (Lond). 2014 Apr;38(4):494-506. doi: 10.1038/ijo.2013.142. Epub 2013 Aug 5.
PubMed 23913029Tirosh A, Shai I, Afek A, Dubnov-Raz G, Ayalon N, Gordon B, Derazne E, Tzur D, Shamis A, Vinker S, Rudich A. Adolescent BMI trajectory and risk of diabetes versus coronary disease. N Engl J Med. 2011 Apr 7;364(14):1315-25. doi: 10.1056/NEJMoa1006992.
PubMed 21470009Lee JM, Gebremariam A, Vijan S, Gurney JG. Excess body mass index-years, a measure of degree and duration of excess weight, and risk for incident diabetes. Arch Pediatr Adolesc Med. 2012 Jan;166(1):42-8. doi: 10.1001/archpedi.166.1.42.
PubMed 22213749TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
PubMed 22540912Olivo G, Gour S, Schioth HB. Low neuroticism and cognitive performance are differently associated to overweight and obesity: A cross-sectional and longitudinal UK Biobank study. Psychoneuroendocrinology. 2019 Mar;101:167-174. doi: 10.1016/j.psyneuen.2018.11.014. Epub 2018 Nov 12.
PubMed 30469083Ronan L, Alexander-Bloch A, Fletcher PC. Childhood Obesity, Cortical Structure, and Executive Function in Healthy Children. Cereb Cortex. 2020 Apr 14;30(4):2519-2528. doi: 10.1093/cercor/bhz257.
PubMed 31646343Maayan L, Hoogendoorn C, Sweat V, Convit A. Disinhibited eating in obese adolescents is associated with orbitofrontal volume reductions and executive dysfunction. Obesity (Silver Spring). 2011 Jul;19(7):1382-7. doi: 10.1038/oby.2011.15. Epub 2011 Feb 24.
PubMed 21350433Volkow ND, Wang GJ, Baler RD. Reward, dopamine and the control of food intake: implications for obesity. Trends Cogn Sci. 2011 Jan;15(1):37-46. doi: 10.1016/j.tics.2010.11.001. Epub 2010 Nov 24.
PubMed 21109477Hollmann M, Hellrung L, Pleger B, Schlogl H, Kabisch S, Stumvoll M, Villringer A, Horstmann A. Neural correlates of the volitional regulation of the desire for food. Int J Obes (Lond). 2012 May;36(5):648-55. doi: 10.1038/ijo.2011.125. Epub 2011 Jun 28.
PubMed 21712804Boeka AG, Lokken KL. Neuropsychological performance of a clinical sample of extremely obese individuals. Arch Clin Neuropsychol. 2008 Jul;23(4):467-74. doi: 10.1016/j.acn.2008.03.003. Epub 2008 Apr 29.
PubMed 18448310Galioto R, Bond D, Gunstad J, Pera V, Rathier L, Tremont G. Executive functions predict weight loss in a medically supervised weight loss programme. Obes Sci Pract. 2016 Dec;2(4):334-340. doi: 10.1002/osp4.70. Epub 2016 Sep 28.
PubMed 28090338Dassen FCM, Houben K, Allom V, Jansen A. Self-regulation and obesity: the role of executive function and delay discounting in the prediction of weight loss. J Behav Med. 2018 Dec;41(6):806-818. doi: 10.1007/s10865-018-9940-9. Epub 2018 May 25.
PubMed 29802535Butryn ML, Martinelli MK, Remmert JE, Roberts SR, Zhang F, Forman EM, Manasse SM. Executive Functioning as a Predictor of Weight Loss and Physical Activity Outcomes. Ann Behav Med. 2019 Aug 29;53(10):909-917. doi: 10.1093/abm/kaz001.
PubMed 30689688Allom V, Mullan B, Smith E, Hay P, Raman J. Breaking bad habits by improving executive function in individuals with obesity. BMC Public Health. 2018 Apr 16;18(1):505. doi: 10.1186/s12889-018-5392-y.
PubMed 29661241
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Stigma: Novel Moderators in the Relationship Between Weight Status and Cognitive Function
- ClinicalTrials.gov ID
- NCT04346433
- Acronym / sponsor ID
- TBD2020
- Conditions
- Obesity, Childhood, Overweight, Childhood
- Keywords
- sleep, stigma, cognitive function, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Normal Weight | Experimental | Behavioral: Restricted Sleep, Behavioral: Adequate SleepThis 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. |
| Adolescents with Overweight or Obesity | Experimental | Behavioral: Restricted Sleep, Behavioral: Adequate SleepThis 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. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescent ages 14-19
Key exclusion criteria (8 listed)
- age under 14 or over 19
- sleep disorder
- use of medications which impact sleep
- learning disorder
- history of eating disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Restricted SleepDuring the restricted sleep condition adolescents will sleep 4 hours ±1 hour (0100-0500). This condition will last 1 night. | Behavioural | Adolescents with Normal Weight, Adolescents with Overweight or Obesity |
| Adequate SleepDuring the adequate sleep condition adolescents will sleep 9 hours ±1 hour (2100- 0800). This condition will last 1 night. | Behavioural | Adolescents with Normal Weight, Adolescents with Overweight or Obesity |
Primary outcome
Objectively Measured Cognitive Function Composite Score After Sleep Restriction
Time frame: Immediately after the sleep restricted intervention
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
Time frame: Immediately after the adequate sleep intervention
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
Time frame: Immediately after the sleep restricted intervention
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
Time frame: Immediately after the adequate sleep intervention
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
Time frame: Immediately after the sleep restricted intervention
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
Time frame: Immediately after the adequate sleep intervention
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
Time frame: Immediately after the sleep restricted intervention
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
Time frame: Immediately after the adequate sleep intervention
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
Time frame: Immediately after the sleep restricted intervention
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
Time frame: Immediately after the adequate sleep intervention
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
Time frame: Immediately after the sleep restricted intervention
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
Time frame: Immediately after the adequate sleep intervention
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
Time frame: Immediately after the sleep restricted intervention
Measured using the Stroop Task
Objectively Measured Inhibition After Adequate Sleep
Time frame: Immediately after the adequate sleep intervention
Measured using the Stroop Task
Objectively Measured Episodic Memory After Adequate Sleep
Time frame: Immediately after the adequate sleep intervention
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
Time frame: Immediately after the restricted sleep intervention
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.
7 secondary outcomes
Subjectively Measured Behavior Regulation
Time frame: Baseline
Subjectively Measured Emotional Regulation
Time frame: Baseline
Subjectively Measured Cognitive Regulation
Time frame: Baseline
Subjectively Measured Global Executive Composite
Time frame: Baseline
Food Consumption After Sleep Restriction
Time frame: Immediately after the sleep restricted intervention
Food Consumption After Adequate Sleep
Time frame: Immediately after the adequate sleep intervention
Stigma Experiences
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Background: PubMed 15837955Daniels SR, Arnett DK, Eckel RH, Gidding SS, Hayman LL, Kumanyika S, Robinson TN, Scott BJ, St Jeor S, Williams CL. Overweight in children and adolescents: pathophysiology, consequences, prevention, and treatment. Circulation. 2005 Apr 19;111(15):1999-2012. doi: 10.1161/01.CIR.0000161369.71722.10.
- Background: PubMed 23913029Liang J, Matheson BE, Kaye WH, Boutelle KN. Neurocognitive correlates of obesity and obesity-related behaviors in children and adolescents. Int J Obes (Lond). 2014 Apr;38(4):494-506. doi: 10.1038/ijo.2013.142. Epub 2013 Aug 5.
- Background: PubMed 21470009Tirosh A, Shai I, Afek A, Dubnov-Raz G, Ayalon N, Gordon B, Derazne E, Tzur D, Shamis A, Vinker S, Rudich A. Adolescent BMI trajectory and risk of diabetes versus coronary disease. N Engl J Med. 2011 Apr 7;364(14):1315-25. doi: 10.1056/NEJMoa1006992.
- Background: PubMed 22213749Lee JM, Gebremariam A, Vijan S, Gurney JG. Excess body mass index-years, a measure of degree and duration of excess weight, and risk for incident diabetes. Arch Pediatr Adolesc Med. 2012 Jan;166(1):42-8. doi: 10.1001/archpedi.166.1.42.
- Background: PubMed 22540912TODAY Study Group; Zeitler P, Hirst K, Pyle L, Linder B, Copeland K, Arslanian S, Cuttler L, Nathan DM, Tollefsen S, Wilfley D, Kaufman F. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med. 2012 Jun 14;366(24):2247-56. doi: 10.1056/NEJMoa1109333. Epub 2012 Apr 29.
- Background: PubMed 30469083Olivo G, Gour S, Schioth HB. Low neuroticism and cognitive performance are differently associated to overweight and obesity: A cross-sectional and longitudinal UK Biobank study. Psychoneuroendocrinology. 2019 Mar;101:167-174. doi: 10.1016/j.psyneuen.2018.11.014. Epub 2018 Nov 12.
- Background: PubMed 31646343Ronan L, Alexander-Bloch A, Fletcher PC. Childhood Obesity, Cortical Structure, and Executive Function in Healthy Children. Cereb Cortex. 2020 Apr 14;30(4):2519-2528. doi: 10.1093/cercor/bhz257.
- Background: PubMed 21350433Maayan L, Hoogendoorn C, Sweat V, Convit A. Disinhibited eating in obese adolescents is associated with orbitofrontal volume reductions and executive dysfunction. Obesity (Silver Spring). 2011 Jul;19(7):1382-7. doi: 10.1038/oby.2011.15. Epub 2011 Feb 24.
- Background: PubMed 21109477Volkow ND, Wang GJ, Baler RD. Reward, dopamine and the control of food intake: implications for obesity. Trends Cogn Sci. 2011 Jan;15(1):37-46. doi: 10.1016/j.tics.2010.11.001. Epub 2010 Nov 24.
- Background: PubMed 21712804Hollmann M, Hellrung L, Pleger B, Schlogl H, Kabisch S, Stumvoll M, Villringer A, Horstmann A. Neural correlates of the volitional regulation of the desire for food. Int J Obes (Lond). 2012 May;36(5):648-55. doi: 10.1038/ijo.2011.125. Epub 2011 Jun 28.
- Background: PubMed 18448310Boeka AG, Lokken KL. Neuropsychological performance of a clinical sample of extremely obese individuals. Arch Clin Neuropsychol. 2008 Jul;23(4):467-74. doi: 10.1016/j.acn.2008.03.003. Epub 2008 Apr 29.
- Background: PubMed 28090338Galioto R, Bond D, Gunstad J, Pera V, Rathier L, Tremont G. Executive functions predict weight loss in a medically supervised weight loss programme. Obes Sci Pract. 2016 Dec;2(4):334-340. doi: 10.1002/osp4.70. Epub 2016 Sep 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aaron D Fobian, PhD study director
The University of Alabama at Birmingham
Lindsay M Stager principal investigator
The University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Restricted Sleep and Adequate Sleep in people with Obesity, Childhood and Overweight, Childhood, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objectively Measured Cognitive Function Composite Score After Sleep Restriction (time frame: Immediately after the sleep restricted intervention). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04346433, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.