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CompletedNCT02787577SLuMBERUpdated Sep 17, 2019

The Sleep Lengthening and Metabolic Health, Body Composition, Energy Balance and Cardiovascular Risk Study

An interventional study of Sleep Lengthening in Sleep, sponsored by King's College London. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-17.

Sponsored by King's College London · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

Short sleep duration has been associated with increased risk of weight gain and development of non-communicable diseases. Sleep deprivation studies have suggested the link between restricted sleep and risk of adiposity and cardiometabolic dysregulation may be causal. However, the severity and acuteness of sleep restriction schedules in laboratory-based studies could hinder the ecological validity of the findings. The pragmatic way forward is to assess how improved sleep in habitually short sleepers impacts the aforementioned outcomes. This study assesses the feasibility of lengthening sleep in short sleepers, as well as how improved sleep duration and/or quality impact metabolic health, body composition, energy balance and cardiovascular risk.

Read the detailed description

Research Questions

  • Is it feasible to improve sleep duration and quality in habitually short sleepers under free-living conditions?
  • What are the effects of improved sleep duration and quality on body composition, energy balance, dietary intake, and cardio-metabolic risk factors?

Hypothesis

- Improved sleep duration and/or quality in habitually short sleepers will result in improved energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Aims

  • To assess the feasibility of improving sleep duration and/or quality in habitually short sleepers using behavioural approaches and public health messages targeting sleep hygiene.
  • To identify how improved sleep duration and/or quality affect energy balance, diet quality, body composition, and cardio-metabolic risk profile.

Objectives

  1. To develop a sleep extension strategy using behaviour change techniques (BCTs) targeting sleep hygiene.
  2. To recruit healthy adults who are habitually short sleepers and randomise eligible participants to an intervention and control group.
  3. To assess the feasibility and effectiveness of the intervention.
  4. To measure energy balance, diet quality, body composition and cardio-metabolic risk factors pre- and post-treatment in the intervention and control groups.
  5. To assess whether the intervention had an effect on the aforementioned parameters by comparing the intervention endpoints to control as well as baseline measures.
  6. To run the statistical analysis both on an intention-to-treat basis as well as per-protocol.
02

Conditions studied

  • Sleep

Keywords

  • Sleep Duration
  • Sleep Quality
  • Body Composition
  • Energy Intake
  • Energy Expenditure
  • Energy Balance
  • Cardiovascular Risk
03

In context

Sleep Initiation and Maintenance Disorders

1,925 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 612 are open to participants now.

This study's enrollment of 43 is below the median of 72 across 1,689 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

King's College London is the lead sponsor of 519 studies on the registry; 126 are open to participants now.

Browse King's College London studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male and female adults (18-64 years)
  • Habitually short sleepers (5-\<7 hours of sleep per night on average on weekdays) - this is self-reported at screening, and confirmed by actigraphy when baseline measurement is taken.
  • BMI: 18.5 - \<30

Exclusion criteria

Exclusion Criteria:

  • Diagnosed medical conditions such as:
  • Cardiovascular disease
  • Type 1 or Type 2 Diabetes Mellitus
  • Cancer (excluding basal carcinoma) in the past five years
  • Chronic renal or liver disease
  • Inflammatory bowel disease
  • Hypo/hyperthyroidism
  • Sleep conditions:
  • Chronic use of sleeping aid medication
  • Insomnia (Insomnia Severity Index - ISI Questionnaire)
  • Sleep apnoea (Berlin Questionnaire)
  • Extreme Chronotype (HorneOstberg questionnaire)
  • Pregnancy or lactation
  • Weight change of >3 kg in the previous two months
  • Previous or current high alcohol intake (>28 units/week for males and >21 units/week for females) or substance abuse
  • Smoking
  • Working hours outside 7 am - 7 pm
  • Habitual napping (>20 minutes per day on a regular basis)
  • Obliged to wake and care for family/friends (e.g. new born child etc)
  • Use of antidepressants
  • Depressed mood (Center of Epidemiologic Studies of Depression 20-item scale questionnaire)
  • Travel arrangements outside time zone within the periods of data collection
  • Travel arrangements outside time zone within period of intervention/control condition
  • Inability to adhere to a sleep hygiene intervention/sleep schedule due to time commitments
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Sleep Lengthening

    The intervention group will receive a personalised sleep consultation session to lengthen sleep by 1-1.5 hours per night by targeting sleep hygiene using behaviour change techniques for 4 weeks.

    Behavioral: Sleep Lengthening

  • No intervention
    Control

    The control group will be asked to resume their normal lifestyle.

Interventions

  • BehavioralSleep Lengthening

    Behaviour change techniques targeting sleep hygiene

06

What researchers measure

Primary outcomes

  1. Sleep Duration

    Wrist Actigraphy

    Time frame: baseline

  2. Sleep Duration

    Wrist Actigraphy

    Time frame: week 4

  3. Sleep Quality

    Wrist Actigraphy

    Time frame: baseline

  4. Sleep Quality

    Wrist Actigraphy

    Time frame: week 4

Secondary outcomes

  1. BMI

    Time frame: baseline

  2. BMI

    Time frame: day 28

  3. Body fat percentage

    Time frame: baseline

  4. Body fat percentage

    Time frame: day 28

  5. Blood pressure

    Time frame: baseline

  6. Blood pressure

    Time frame: day 28

  7. Fasting blood glucose

    Time frame: baseline

  8. Fasting blood glucose

    Time frame: day 28

  9. Fasting total cholesterol

    Time frame: baseline

  10. Fasting HDL cholesterol

    Time frame: baseline

  11. Fasting LDL cholesterol

    Time frame: baseline

  12. Fasting triglycerides

    Time frame: baseline

  13. Fasting total cholesterol

    Time frame: day 28

  14. Fasting HDL cholesterol

    Time frame: day 28

  15. Fasting LDL cholesterol

    Time frame: day 28

  16. Fasting triglycerides

    Time frame: day 28

  17. plasma leptin

    Time frame: baseline

  18. plasma leptin

    Time frame: day 28

  19. plasma ghrelin

    Time frame: baseline

  20. plasma ghrelin

    Time frame: day 28

  21. plasma insulin

    Time frame: baseline

  22. plasma insulin

    Time frame: day 28

  23. plasma cortisol

    Time frame: baseline

  24. plasma cortisol

    Time frame: day 28

  25. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Time frame: baseline

  26. Homeostasis model assessment estimated insulin resistance (HOMA-IR)

    Time frame: day 28

  27. Waist circumference

    Time frame: baseline

  28. Waist circumference

    Time frame: day 28

  29. Hip circumference

    Time frame: baseline

  30. Hip circumference

    Time frame: day 28

  31. Lean body mass

    Time frame: baseline

  32. Lean body mass

    Time frame: day 28

  33. Digital volume pulse - Stiffness Index (SI)

    Time frame: baseline

  34. Digital volume pulse - Stiffness Index (SI)

    Time frame: day 28

  35. Digital volume pulse - Reflection Index (RI)

    Time frame: baseline

  36. Digital volume pulse - Reflection Index (RI)

    Time frame: day 28

  37. Mnemonic Similarity Test (MST)

    Time frame: baseline

  38. Mnemonic Similarity Test (MST)

    Time frame: day 28

  39. Dietary Intake (7-day food diary)

    Time frame: baseline

  40. Dietary Intake (7-day food diary)

    Time frame: week 4

  41. Resting Metabolic Rate (RMR)

    Time frame: baseline

  42. Resting Metabolic Rate (RMR)

    Time frame: day 28

  43. Total Energy Expenditure (TEE)

    Time frame: baseline

  44. Total Energy Expenditure (TEE)

    Time frame: day 21-23

  45. Urinary 6-sulphatoxymelatonin

    Analysed from spot urine sample

    Time frame: baseline

  46. Urinary 6-sulphatoxymelatonin

    Analysed from spot urine sample

    Time frame: day 28

  47. Recent Physical Activity Questionnaire (RPAQ)

    Time frame: baseline

  48. Recent Physical Activity Questionnaire (RPAQ)

    Time frame: day 28

  49. Sleep Hygiene Index (SHI)

    Time frame: baseline

  50. Sleep Hygiene Index (SHI)

    Time frame: day 28

  51. Eating Choices Index (ECI)

    Time frame: baseline

  52. Eating Choices Index (ECI)

    Time frame: day 28

  53. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline

  54. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: day 28

Other outcomes

  1. Dutch Eating Behaviour Questionnaire (DEBQ)

    Time frame: baseline

  2. Women's Health Questionnaire

    Questionnaire to identify menstrual phase

    Time frame: baseline

  3. Women's Health Questionnaire

    Questionnaire to identify menstrual phase

    Time frame: day 21

07

Study locations

1 site
  • Diabetes & Nutritional Sciences Division, King's College London
    London, SE1 9NH, United Kingdom
08

References and documents

Publications

  • Bosy-Westphal A, Hinrichs S, Jauch-Chara K, Hitze B, Later W, Wilms B, Settler U, Peters A, Kiosz D, Muller MJ. Influence of partial sleep deprivation on energy balance and insulin sensitivity in healthy women. Obes Facts. 2008;1(5):266-73. doi: 10.1159/000158874. Epub 2008 Oct 23. PubMed 20054188 ↗
  • Brondel L, Romer MA, Nougues PM, Touyarou P, Davenne D. Acute partial sleep deprivation increases food intake in healthy men. Am J Clin Nutr. 2010 Jun;91(6):1550-9. doi: 10.3945/ajcn.2009.28523. Epub 2010 Mar 31. PubMed 20357041 ↗
  • Buxton OM, Pavlova M, Reid EW, Wang W, Simonson DC, Adler GK. Sleep restriction for 1 week reduces insulin sensitivity in healthy men. Diabetes. 2010 Sep;59(9):2126-33. doi: 10.2337/db09-0699. Epub 2010 Jun 28. PubMed 20585000 ↗
  • Markwald RR, Melanson EL, Smith MR, Higgins J, Perreault L, Eckel RH, Wright KP Jr. Impact of insufficient sleep on total daily energy expenditure, food intake, and weight gain. Proc Natl Acad Sci U S A. 2013 Apr 2;110(14):5695-700. doi: 10.1073/pnas.1216951110. Epub 2013 Mar 11. PubMed 23479616 ↗
  • Shechter A, Rising R, Albu JB, St-Onge MP. Experimental sleep curtailment causes wake-dependent increases in 24-h energy expenditure as measured by whole-room indirect calorimetry. Am J Clin Nutr. 2013 Dec;98(6):1433-9. doi: 10.3945/ajcn.113.069427. Epub 2013 Oct 2. PubMed 24088722 ↗
  • Spiegel K, Leproult R, Van Cauter E. Impact of sleep debt on metabolic and endocrine function. Lancet. 1999 Oct 23;354(9188):1435-9. doi: 10.1016/S0140-6736(99)01376-8. PubMed 10543671 ↗
  • St-Onge MP, Roberts AL, Chen J, Kelleman M, O'Keeffe M, RoyChoudhury A, Jones PJ. Short sleep duration increases energy intakes but does not change energy expenditure in normal-weight individuals. Am J Clin Nutr. 2011 Aug;94(2):410-6. doi: 10.3945/ajcn.111.013904. Epub 2011 Jun 29. PubMed 21715510 ↗
  • St-Onge MP, O'Keeffe M, Roberts AL, RoyChoudhury A, Laferrere B. Short sleep duration, glucose dysregulation and hormonal regulation of appetite in men and women. Sleep. 2012 Nov 1;35(11):1503-10. doi: 10.5665/sleep.2198. PubMed 23115399 ↗
  • Al Khatib HK, Hall WL, Creedon A, Ooi E, Masri T, McGowan L, Harding SV, Darzi J, Pot GK. Sleep extension is a feasible lifestyle intervention in free-living adults who are habitually short sleepers: a potential strategy for decreasing intake of free sugars? A randomized controlled pilot study. Am J Clin Nutr. 2018 Jan 1;107(1):43-53. doi: 10.1093/ajcn/nqx030. PubMed 29381788 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02787577
Lead sponsor
King's College London
Responsible party
Sponsor
First posted
Jun 1, 2016
Start date
Apr 2016
Primary completion
Dec 2016
Completion
Dec 2016
Last update
Sep 17, 2019

Study contacts

Wendy Hall, PhD
principal investigator · King's College London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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