SleepNCT01030107
Effects of Sleep Duration on Eating and Activity Behaviors
An observational study of Sleep and Obesity, run by The Miriam Hospital at 1 site in United States.
Trial summary
The purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. Read more about this study
- Who is it for?
- Ages 8 to 11 yearsHealthy volunteers can take part
- What is being tested?
- Increase Sleep and Decrease Sleep
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Jan 2012
- Phase
- Observational
- 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 8 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children ages 8-11 years old recruited from Southeastern New England.
Who may be able to join
- Age 8-11 years old
- BMI for age and gender > 5th percentile (but no greater than 100% overweight)
- Sleep approximately 9-10 hours nightly
- Attend elementary school
- Like at least 1 food and 1 activity used in the reinforcement paradigm
- Able to understand and complete the reinforcement paradigm
Who cannot join
- Existence of a diagnosable sleep disorder
- Medical or psychiatric condition that could influence sleep or weight
- Onset of menarche
- Inability to complete study materials, including diagnosed disabilities
- Dietary restrictions/allergies to foods used in the study that preclude them from study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Weight Control and Diabetes Research Center
Providence, Rhode Island, 02903
About this study
Official title: Sleep Duration and Pediatric Overweight: the Role of Eating Behaviors
The purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. For 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to increase their sleep first and half to decrease their sleep first. During each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight. We believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.
- Being tested
- Increase Sleep, Decrease Sleep
- Keywords
- sleep, obesity, children, eating behaviors, activity, leptin, ghrelin
- Medical subject headings
- Obesity, Feeding Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Increase SleepBehavioural
Children are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week.
Decrease SleepBehavioural
Children are asked to decrease their sleep by approximately 1 1/2 hours/night.
| Study group | Role | What they receive |
|---|---|---|
| Children with Insufficient Sleep | Children who sleep approximately 9-10 hours/night Receives: Behavioral: Increase Sleep; Behavioral: Decrease Sleep |
What is being measured
The primary outcome is the main question the study is designed to answer.
absolute reinforcing value of food as compared to sedentary activities
Measured: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
Secondary outcomes (4)
plasma levels of leptin and ghrelin
Measured: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
caloric intake
Measured: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
levels of physical activity
Measured: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
subjective ratings of hunger and appetite
Measured: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- American Diabetes Association
- Responsible party
- Sponsor
- Investigators
- Chantelle N Hart, PhD, Principal investigator, The Miriam Hospital/Alpert Medical School of Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01030107
- Sponsor's protocol ID
- 1-08-JF-17
- Status last verified
- Apr 2011
- First submitted
- 9 Dec 2009
- Last updated
- 5 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Hart CN, Spaeth AM, Egleston BL, Carskadon MA, Raynor HA, Jelalian E, Owens JA, Considine RV, Wing RR. Effect of changes in children's bedtime and sleep period on targeted eating behaviors and timing of caloric intake. Eat Behav. 2022 Apr;45:101629. doi: 10.1016/j.eatbeh.2022.101629. Epub 2022 Mar 26.
PubMed 35390756Hart CN, Carskadon MA, Considine RV, Fava JL, Lawton J, Raynor HA, Jelalian E, Owens J, Wing R. Changes in children's sleep duration on food intake, weight, and leptin. Pediatrics. 2013 Dec;132(6):e1473-80. doi: 10.1542/peds.2013-1274. Epub 2013 Nov 4.
PubMed 24190680
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Duration and Pediatric Overweight: the Role of Eating Behaviors
- ClinicalTrials.gov ID
- NCT01030107
- Acronym / sponsor ID
- 1-08-JF-17
- Keywords
- sleep, obesity, children, eating behaviors, activity, leptin, ghrelin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- American Diabetes Association
- Study start
- Feb 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Dec 2009 (estimated)
- 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 purpose of the proposed study is to determine whether the amount children sleep is associated with changes in hormones, hunger, motivation to eat, and food intake. Fifty children 8-11 years old who sleep 9-10 hours per night will be enrolled for a 3-week study. For 1 week each, children will be asked to sleep their typical amount, increase their sleep by 1-½ hours, and decrease their sleep by 1-½ hours. Half of the children will be asked to increase their sleep first and half to decrease their sleep first. During each week, the following will be gathered: sleep duration (measured by actigraphy, which is a small device that measures sleep), levels of hormones measured through blood draws, self-reported hunger and appetite, food intake (measured by 3 days of 24-hour recall), how motivated children are to eat (measured using a computer activity), and child height and weight. We believe that when children sleep less they will show changes in hormones associated with hunger and appetite, report being hungrier, be more motivated to eat, and eat more food.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children with Insufficient Sleep | – | Behavioral: Increase Sleep, Behavioral: Decrease SleepChildren who sleep approximately 9-10 hours/night |
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children ages 8-11 years old recruited from Southeastern New England.
Key inclusion criteria (6 listed)
- Age 8-11 years old
- BMI for age and gender > 5th percentile (but no greater than 100% overweight)
- Sleep approximately 9-10 hours nightly
- Attend elementary school
- Like at least 1 food and 1 activity used in the reinforcement paradigm
Key exclusion criteria (5 listed)
- Existence of a diagnosable sleep disorder
- Medical or psychiatric condition that could influence sleep or weight
- Onset of menarche
- Inability to complete study materials, including diagnosed disabilities
- Dietary restrictions/allergies to foods used in the study that preclude them from study participation
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 |
|---|---|---|
| Increase SleepChildren are asked to increase their sleep by approximately 1 1/2 hours/night for 1 week. | Behavioural | Children with Insufficient Sleep |
| Decrease SleepChildren are asked to decrease their sleep by approximately 1 1/2 hours/night. | Behavioural | Children with Insufficient Sleep |
Primary outcome
absolute reinforcing value of food as compared to sedentary activities
Time frame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
4 secondary outcomes
plasma levels of leptin and ghrelin
Time frame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
caloric intake
Time frame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
levels of physical activity
Time frame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
subjective ratings of hunger and appetite
Time frame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration
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 5 Oct 2012.
- Derived from this study: PubMed 35390756Hart CN, Spaeth AM, Egleston BL, Carskadon MA, Raynor HA, Jelalian E, Owens JA, Considine RV, Wing RR. Effect of changes in children's bedtime and sleep period on targeted eating behaviors and timing of caloric intake. Eat Behav. 2022 Apr;45:101629. doi: 10.1016/j.eatbeh.2022.101629. Epub 2022 Mar 26.
- Derived from this study: PubMed 24190680Hart CN, Carskadon MA, Considine RV, Fava JL, Lawton J, Raynor HA, Jelalian E, Owens J, Wing R. Changes in children's sleep duration on food intake, weight, and leptin. Pediatrics. 2013 Dec;132(6):e1473-80. doi: 10.1542/peds.2013-1274. Epub 2013 Nov 4.
- Weight Control and Diabetes Research CenterLink provided by the sponsor.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
Chantelle N Hart, PhD principal investigator
The Miriam Hospital/Alpert Medical School of Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep and Obesity, run by The Miriam Hospital 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 6 inclusion and 5 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 5 Oct 2012. 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?
absolute reinforcing value of food as compared to sedentary activities (time frame: after 1 week of typical sleep duration, after 1 week of decreased sleep duration, after 1 week of increased sleep duration). 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 NCT01030107, which also lists 2 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 5 Oct 2012.