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Trial registered on ANZCTR


Registration number
ACTRN12618001671257
Ethics application status
Approved
Date submitted
3/10/2018
Date registered
10/10/2018
Date last updated
18/09/2019
Date data sharing statement initially provided
18/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
How does not getting enough sleep change what children eat and do? The DREAM Study
Scientific title
How does not getting enough sleep change what children eat and do? The DREAM Study
Secondary ID [1] 296035 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
DREAM (Daily Rest, Eating & Activity Monitoring)
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Obesity 309579 0
Sleep 309580 0
Condition category
Condition code
Public Health 308401 308401 0 0
Other public health
Diet and Nutrition 308402 308402 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This experimental crossover study aims to determine how mild sleep deprivation might influence eating behaviour and activity patterns in children. As it is not known exactly how much sleep each individual child needs, all children will undergo two experimental sleep conditions. In the sleep restriction week (arm 1), the child will go to bed 1 hour later than they normally do, while maintaining usual wake up time. In the sleep extension week (arm 2), the child will go to bed 1 hour earlier than they normally do, while maintaining usual wake up time. All analyses compare the difference between these two experimental weeks. Because not all children will change sleep by exactly one hour in each condition, we expect that the difference between the two conditions should produce a difference in 'usual' sleep time for each child of 1-2 hours per night. This level of mild sleep deprivation is thought to be common in children.

Total study duration is 5 weeks. During week 1, participants wear a waist-worn Actigraph accelerometer 24-hours a day for 7 days to measure sleep, physical activity and sedentary behaviour. During week 2, researchers determine the child's "usual" lights out (night) and lights on (morning) time from the accelerometry and accompanying sleep diary data. Participants are allocated to sleep restriction or sleep extension conditions using a randomised, counterbalanced, cross-over design (during weeks 3 and 5, with a one week washout in between).

Trained researchers discuss the new bedtime with the parent(s) and child on day 1 of each experimental week during a home visit. Those randomised to sleep extension will be instructed to go to bed one hour earlier than their usual bed time (determined in week 1) each night for 7 nights, while maintaining the usual wake up time. Those randomised to sleep restriction will be instructed to go to bed one hour later than their usual bed time (determined in week 1) each night for 7 nights, while maintaining the usual wake up time. Naps are not allowed. Changing bed time while maintaining wake time reflects the real world where wake times remain relatively constant in children. We will work with parents and children to determine how best to ensure adherence for each family using a variety of strategies including goal setting, securing motivation, preplanning, problem solving, self monitoring and positive reinforcement. Daily text reminders will also encourage adherence.

Children wear the accelerometer 24-hours a day during each experimental week (7 full days and nights) and parents complete an accompanying sleep diary, noting lights off and lights on time each day, and time and reason for accelerometer removal (e.g. shower or swimming).

One two days of each experimental week, children also wear a small automated camera during waking hours only. This camera attached to the lapel, is worn facing outwards, and automatically takes a picture of the child's environment.
Intervention code [1] 312375 0
Lifestyle
Comparator / control treatment
As this a cross-over design, there are two active conditions (sleep restriction and sleep restriction) and no control condition per se. Baseline measures are collected in week 1 but these are used to: (a) describe the sample, (b) determine how bedtime needs to change specifically for each child during the sleep extension and restriction arms, and (c) familiarise participants with the equipment. The main analyses compare outcomes between restriction and extension weeks and do not include the baseline measures.
Control group
Active

Outcomes
Primary outcome [1] 307368 0
Eating in the absence of hunger (kJ consumed during the free access phase).

The child is offered a buffet meal which objectively determines energy self-regulation in children using a well-established protocol (Lansigan RK et al Appetite 2015; 85: 36-47). Children eat ad-libitum until they are full (preload phase) then are provided with an opportunity to eat highly palatable snacks (lollies, chips, ice cream etc) while playing with toys for 15 minutes without obvious adult supervision (free access phase). The snacks are weighed before and after the free access phase, and each child’s energy intake from these foods is calculated; the child’s energy intake from these foods represents their response to eating in the absence of hunger.
Timepoint [1] 307368 0
At the end of each experimental week (weeks 3 and 5) i.e. after 7 nights of sleep manipulation.
Secondary outcome [1] 351648 0
Total daily energy intake assessed using multiple 24-hour recalls.
Timepoint [1] 351648 0
Days 2, 4 and 7 of each experimental week (weeks 3 and 5).
Secondary outcome [2] 351649 0
Indices from the Children's Eating Behaivor Questionnaire (Wardle et al, J Child Psychol Psychiat 2001;42:963), e.g. emotional over-eating, satiety responsiveness, and food responsiveness.
Timepoint [2] 351649 0
At the end of each experimental week (weeks 3 and 5) i.e. after 7 nights of sleep manipulation.
Secondary outcome [3] 351650 0
Craving for core versus non core foods.

Children are shown pictures of 60 foods differing in nutritional quality (30 core, 30 non-core) and asked to rate how much they would like to eat each food right now on a sliding scale between “not at all” to “heaps”. This testing occurs before the eating in the absence of hunger experiment.
Timepoint [3] 351650 0
At the end of each experimental week (weeks 3 and 5) i.e. after 7 nights of sleep manipulation.
Secondary outcome [4] 351651 0
Compositional time-use data (24-hour accelerometry data measuring sleep, awake after sleep onset, sedentary time, and time in light, moderate and vigorous activity).
Timepoint [4] 351651 0
Experimental weeks 3 and 5 (7 24-hour periods for each).
Secondary outcome [5] 351652 0
The context of eating (who child eats with, where, and what else they are doing at the same time).

A small auto-camera will be attached to the lapel on days 2 and 7 which automatically takes a picture every 15 seconds. The images will provide information regarding the environmental context of eating as it occurs in the free-living environment.
Timepoint [5] 351652 0
Days 2 and 7 of each experimental week (weeks 3 and 5).
Secondary outcome [6] 351653 0
Quality of life over the past 7 days measured using the Kidscreen-27 questionnaire (Qual Life Res 2014;23:791-803).
Timepoint [6] 351653 0
At the end of each experimental week (weeks 3 and 5) i.e. after 7 nights of sleep manipulation.
Secondary outcome [7] 351654 0
Weight using electronic scales
Timepoint [7] 351654 0
At the end of each experimental week (weeks 3 and 5) i.e. after 7 nights of sleep manipulation.
Secondary outcome [8] 351655 0
Sleep disturbances and impairment over the past 7 days (using the PROMIS questionnaire, Forrest CB et al, Sleep 2018;zsy054).
Timepoint [8] 351655 0
At the end of each experimental week (weeks 3 and 5) i.e. after 7 nights of sleep manipulation.

Eligibility
Key inclusion criteria
8-12 years of age.
Reported usual sleep duration of 8-11 hours per night.
Minimum age
8 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children identified as having:
i) a sleep disorder (using the Sleep Disturbance Scale for Children, Bruni et al, J Sleep Res 1996;5:251-61), or a
ii) chronic medical condition or physical disability that impedes their ability to participate in physical activity.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
YES, the person determining who is eligible is unaware at the time of inclusion of group allocation. Allocation is done by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
N/A
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power: Our primary outcome is to determine a difference in eating in the absence of hunger from the feeding experiment. Based on a standard deviation of 870kJ and a within-person correlation of 0.7 (Int J Obes 2008; 32: 1499-1505), a sample size of 59 would be required to detect a difference of 250 kJ in energy intake between the two different sleep conditions (80% power, p<0.05). 250kJ is equivalent to approximately 1.5 plain biscuits or 6 potato crisps. These numbers will also allow us to detect important differences in energy intake (secondary outcome) from the diet recalls, over the total day (500kJ difference, n=85) or just at night (200kJ difference, n=50) (Pediatrics 2013;132:1-8). Recruiting 110 children will allow for 20% drop-out and incomplete data.

Statistical analyses: Mixed effects regression models will be used to determine mean differences between the two experimental conditions (sleep restriction and sleep extension) with participant ID as a random effect which accounts for both within-person and between-person variation. Skewed data will be log-transformed as appropriate. 24-hour movement data (actigraphy) will be analysed using fractional multinomial logit models to account for the compositional nature of the data.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 20832 0
New Zealand
State/province [1] 20832 0
Otago

Funding & Sponsors
Funding source category [1] 300627 0
University
Name [1] 300627 0
University of Otago
Address [1] 300627 0
PO Box 56
Dunedin 9010
Country [1] 300627 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
PO Box 56
Dunedin 9010
Country
New Zealand
Secondary sponsor category [1] 300135 0
None
Name [1] 300135 0
Address [1] 300135 0
Country [1] 300135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301416 0
University of Otago Ethics Committee
Ethics committee address [1] 301416 0
PO Box 56
Dunedin 9010
Ethics committee country [1] 301416 0
New Zealand
Date submitted for ethics approval [1] 301416 0
10/09/2018
Approval date [1] 301416 0
20/09/2018
Ethics approval number [1] 301416 0
18/146

Summary
Brief summary
One in three New Zealand children are overweight or obese and not getting enough sleep may be part of the problem. However, while we know that insufficient sleep is a strong risk factor for obesity, we don’t know why. Research suggests that it changes what we eat, but intervention studies are required to determine whether this is true. This study will produce mild sleep deprivation in 8-12 year old children over one week and measure what effect this has on their appetite, what/when and how they eat, and their participation in physical activity and sedentary behaviour (e.g. screen time).
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 53406 0
Prof Rachael Taylor
Address 53406 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9010
Country 53406 0
New Zealand
Phone 53406 0
+64 470 9180
Fax 53406 0
Email 53406 0
rachael.taylor@otago.ac.nz
Contact person for public queries
Name 53407 0
Prof Rachael Taylor
Address 53407 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9010
Country 53407 0
New Zealand
Phone 53407 0
+64 470 9180
Fax 53407 0
Email 53407 0
rachael.taylor@otago.ac.nz
Contact person for scientific queries
Name 53408 0
Prof Rachael Taylor
Address 53408 0
Department of Medicine
University of Otago
PO Box 56
Dunedin 9010
Country 53408 0
New Zealand
Phone 53408 0
+64 470 9180
Fax 53408 0
Email 53408 0
rachael.taylor@otago.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval has not been specifically obtained for data sharing at this time, but we can in the future if a request is made.
What supporting documents are/will be available?
No other documents available
Summary results
No Results