Clinical trial NCT04346433: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Overweight, Childhood
Keywords: sleep
stigma
cognitive function
nutrition
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 61
Sex: ALL
Minimum age (years): 14
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 .

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)

Primary outcomes:
measure: Objectively Measured Cognitive Function Composite Score After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Objectively Measured Cognitive Function Composite Score After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Fluid Cognition Composite Score After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Objectively Measured Fluid Cognition Composite Score After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Attention After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Objectively Measured Attention After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Working Memory After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Objectively Measured Working Memory After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Processing Speed After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Objectively Measured Processing Speed After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Cognitive Flexibility After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Objectively Measured Cognitive Flexibility After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Inhibition After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Objectively Measured Inhibition After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Episodic Memory After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Objectively Measured Episodic Memory After Restricted Sleep
timeFrame: Immediately after the restricted sleep intervention
Secondary outcomes:
measure: Subjectively Measured Behavior Regulation
timeFrame: Baseline
measure: Subjectively Measured Emotional Regulation
timeFrame: Baseline
measure: Subjectively Measured Cognitive Regulation
timeFrame: Baseline
measure: Subjectively Measured Global Executive Composite
timeFrame: Baseline
measure: Food Consumption After Sleep Restriction
timeFrame: Immediately after the sleep restricted intervention
measure: Food Consumption After Adequate Sleep
timeFrame: Immediately after the adequate sleep intervention
measure: Stigma Experiences
timeFrame: Baseline
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Sparks Center
state: Alabama
Study officials:
affiliation: The University of Alabama at Birmingham
name: Aaron D Fobian, PhD
role: STUDY_DIRECTOR
affiliation: The University of Alabama at Birmingham
name: Lindsay M Stager
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Liang 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.
citation: Tirosh 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.
citation: Lee 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.
citation: TODAY 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.
citation: Olivo 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.
citation: Ronan 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.
citation: Maayan 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.
citation: Volkow 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.
citation: Hollmann 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.
citation: Boeka 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.
citation: Galioto 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.
citation: Dassen 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.
citation: Butryn 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.
citation: Allom 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.
citation: Alosco ML, Galioto R, Spitznagel MB, Strain G, Devlin M, Cohen R, Crosby RD, Mitchell JE, Gunstad J. Cognitive function after bariatric surgery: evidence for improvement 3 years after surgery. Am J Surg. 2014 Jun;207(6):870-6. doi: 10.1016/j.amjsurg.2013.05.018. Epub 2013 Oct 10.
citation: Gonzales MM, Tarumi T, Miles SC, Tanaka H, Shah F, Haley AP. Insulin sensitivity as a mediator of the relationship between BMI and working memory-related brain activation. Obesity (Silver Spring). 2010 Nov;18(11):2131-7. doi: 10.1038/oby.2010.183. Epub 2010 Sep 2.
citation: Lasselin J, Magne E, Beau C, Aubert A, Dexpert S, Carrez J, Laye S, Forestier D, Ledaguenel P, Capuron L. Low-grade inflammation is a major contributor of impaired attentional set shifting in obese subjects. Brain Behav Immun. 2016 Nov;58:63-68. doi: 10.1016/j.bbi.2016.05.013. Epub 2016 May 17.
citation: Chen X, Beydoun MA, Wang Y. Is sleep duration associated with childhood obesity? A systematic review and meta-analysis. Obesity (Silver Spring). 2008 Feb;16(2):265-74. doi: 10.1038/oby.2007.63. No abstract available.
citation: CDC. Sleep and sleep disorders: Data and statistics. 2017.
citation: Capers PL, Fobian AD, Kaiser KA, Borah R, Allison DB. A systematic review and meta-analysis of randomized controlled trials of the impact of sleep duration on adiposity and components of energy balance. Obes Rev. 2015 Sep;16(9):771-82. doi: 10.1111/obr.12296. Epub 2015 Jun 22.
citation: Lo JC, Ong JL, Leong RL, Gooley JJ, Chee MW. Cognitive Performance, Sleepiness, and Mood in Partially Sleep Deprived Adolescents: The Need for Sleep Study. Sleep. 2016 Mar 1;39(3):687-98. doi: 10.5665/sleep.5552.
citation: Alhola P, Polo-Kantola P. Sleep deprivation: Impact on cognitive performance. Neuropsychiatr Dis Treat. 2007;3(5):553-67.
citation: Park H, Tsai KM, Dahl RE, Irwin MR, McCreath H, Seeman TE, Fuligni AJ. Sleep and Inflammation During Adolescence. Psychosom Med. 2016 Jul-Aug;78(6):677-85. doi: 10.1097/PSY.0000000000000340.
citation: Dennis JA, Alazzeh A, Kumfer AM, McDonald-Thomas R, Peiris AN. The Association of Unreported Sleep Disturbances and Systemic Inflammation: Findings from the 2005-2008 NHANES. Sleep Disord. 2018 Oct 9;2018:5987064. doi: 10.1155/2018/5987064. eCollection 2018.
citation: Beebe DW, Simon S, Summer S, Hemmer S, Strotman D, Dolan LM. Dietary intake following experimentally restricted sleep in adolescents. Sleep. 2013 Jun 1;36(6):827-34. doi: 10.5665/sleep.2704.
citation: Wardle J, Guthrie CA, Sanderson S, Rapoport L. Development of the Children's Eating Behaviour Questionnaire. J Child Psychol Psychiatry. 2001 Oct;42(7):963-70. doi: 10.1111/1469-7610.00792.
citation: Ancoli-Israel S, Cole R, Alessi C, Chambers M, Moorcroft W, Pollak CP. The role of actigraphy in the study of sleep and circadian rhythms. Sleep. 2003 May 1;26(3):342-92. doi: 10.1093/sleep/26.3.342.
citation: Vartanian, L. R., Pinkus, R. T., & Smyth, J. M. (2018). Experiences of weight stigma in everyday life: Implications for health motivation. Stigma and Health, 3(2), 85-92. https://doi.org/10.1037/sah0000077
citation: Davis AL, Avis KT, Schwebel DC. The effects of acute sleep restriction on adolescents' pedestrian safety in a virtual environment. J Adolesc Health. 2013 Dec;53(6):785-90. doi: 10.1016/j.jadohealth.2013.07.008. Epub 2013 Sep 3.
citation: Goldberg TE, Harvey PD, Wesnes KA, Snyder PJ, Schneider LS. Practice effects due to serial cognitive assessment: Implications for preclinical Alzheimer's disease randomized controlled trials. Alzheimers Dement (Amst). 2015 Mar 29;1(1):103-11. doi: 10.1016/j.dadm.2014.11.003. eCollection 2015 Mar.
citation: Pilli R, Naidu M, Pingali UR, Shobha JC, Reddy AP. A computerized stroop test for the evaluation of psychotropic drugs in healthy participants. Indian J Psychol Med. 2013 Apr;35(2):180-9. doi: 10.4103/0253-7176.116251.
citation: Sutin AR, Stephan Y, Luchetti M, Terracciano A. Perceived weight discrimination and C-reactive protein. Obesity (Silver Spring). 2014 Sep;22(9):1959-61. doi: 10.1002/oby.20789. Epub 2014 May 14.
citation: Warren M, Beck S, Rayburn J. The State of Obesity Better Policies ofr a Healthier America. 2018.