Evidence map›Paper›PMID 25141012›Full record

Trial reportPloS one2014

Hawthorne effect with transient behavioral and biochemical changes in a randomized controlled sleep extension trial of chronically short-sleeping obese adults: implications for the design and interpretation of clinical studies.

Giovanni Cizza, Paolo Piaggi, Kristina I Rother, Gyorgy Csako, Sleep Extension Study Group

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00261898 (Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity), which is not on this map. Cited by 32 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 4 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00261898 phase2terminatednot on this map

Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity

TypeinterventionalSponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Ran2005 to 2013Enrolled239ConditionsObesity, Chronic Sleep DeprivationArmsIncrease sleep
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Effects of Two-Week Sleep Extension on Glucose Metabolism in Chronically Sleep-Deprived Individuals.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2019
    Trial
  8. Trial
  9. Trial
  10. Trial
  11. Article
  12. Article
  13. Review
  14. Article
  15. Review
  16. Adherence to unilateral hypoglossal nerve stimulation and changes in Epworth Sleepiness Scale scores.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2025
    Article
  17. Article
  18. Observational
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Giovanni CizzaSection on Endocrinology & Genetics, Program on Developmental Endocrinology & Genetics, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland, United States of America.
Paolo PiaggiObesity Research Center, Endocrinology Unit, University Hospital of Pisa, Pisa, Italy.
Kristina I RotherSection on Pediatric Diabetes and Metabolism, Diabetes, Endocrinology, and Obesity Branch/National Institute of Diabetes & Digestive & Kidney Diseases, Bethesda, Maryland, United States of America.
Gyorgy CsakoDepartment of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, Maryland, United States of America.
Sleep Extension Study Group

Funding

Studies in Youths & Young Adults with Obesity & T2DM (07-DK-0115, 10-DK-0163)ZIADK047049 · NIDDK · NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES · PI REITMAN, MARC L · 2009 to 2019
$4.4M
Intramural NIH HHS
6 · The paper itself

Abstract

objectiveTo evaluate the effects of study participation per se at the beginning of a sleep extension trial between screening, randomization, and the run-in visit.

designSubjects were screened, returned for randomization (Comparison vs. Intervention) after 81 days (median), and attended run-in visit 121 days later.

settingOutpatient. PATIENTS: Obese (N = 125; M/F, 30/95; Blacks/Whites/Other, N = 73/44/8), mean weight 107.6±19.7 kg, <6.5 h sleep/night.

interventionNon-pharmacological sleep extension. MEASUREMENTS: Sleep duration (diaries and actigraphy watch), sleep quality (Pittsburgh Sleep Quality Index), daily sleepiness (Epworth Sleepiness Scale), fasting glucose, insulin and lipids.

resultsPrior to any intervention, marked improvements occurred between screening and randomization. Sleep duration increased (diaries: 357.4 ±51.2 vs. 388.1±48.6 min/night; mean±SD; P<0.001 screening vs. randomization; actigraphy: 344.3 ±41.9 vs. 358.6±48.2 min/night; P<0.001) sleep quality improved (9.1±3.2 vs. 8.2±3.0 PSQI score; P<0.001), sleepiness tended to improve (8.9±4.6 vs. 8.3±4.5 ESS score; P = 0.06), insulin resistance decreased (0.327±0.038 vs. 0.351±0.045; Quicki index; P<0.001), and lipids improved, except for HDL-C. Abnormal fasting glucose (25% vs. 11%; P = 0.007), and metabolic syndrome (42% vs. 29%; P = 0.007) both decreased. In absence of intervention, the earlier metabolic improvements disappeared at the run-in visit. LIMITATIONS: Relatively small sample size.

conclusionsImprovements in biochemical and behavioral parameters between screening and randomization changed the "true" study baseline, thereby potentially affecting outcome. While regression to the mean and placebo effect were considered, these findings are most consistent with the "Hawthorne effect", according to which behavior measured in the setting of an experimental study changes in response to the attention received from study investigators. This is the first time that biochemical changes were documented with respect to the Hawthorne effect. The findings have implications for the design and conduct of clinical research.

trial registrationClinicalTrials.gov NCT00261898.

Indexed as

Research DesignActigraphyAdolescentAdultEffect Modifier, EpidemiologicFemaleHumansMaleMiddle AgedObesitySleepSleep Wake DisordersYoung Adult

Identifiers

PMID25141012
PMCPMC4139265

What OpenQuestion holds

Textmetadata
LicenceCC0
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.