AzTrials
AzTrials

ObesityNCT03186508

Enhancing Sleep Duration: Effects on Children's Eating and Activity Behaviors-Renewal

A study testing Optimize Sleep (OS) and Optimize Sleep-Plus (OS-Plus) in people with Obesity and Sleep, run by Temple University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (CV) disturbance. Observational studies with children demonstrate that short sleep increases risk of obesity and other CV risk factors. Read more about this study

Who is it for?
Ages 6 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Obesity, Sleep
What is being tested?
Optimize Sleep (OS) and Optimize Sleep-Plus (OS-Plus)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
149 participants
Where
1 siteUnited States
Study dates
28 Feb 2018to 19 Sep 2023
Phase
Interventional
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 6 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Caregiver-reported child age of 6-11 years
  • < 9.5 Hours time-in-bed for sleep most days/week
  • BMI for age and gender > 25th percentile (but no greater than 100% overweight)
  • Understanding of and ability to complete protocol
  • Self-reported caregiver age of 18 years and primary caregiver at bedtimes/wake times
  • Likes food used in the eating regulation paradigms
  • Willingness to be randomized to either treatment condition.

Who cannot join

  • Diagnosable sleep disorder
  • Medication use or diagnosis of medical or psychiatric condition that may impact sleep/weight status
  • Current or planned treatment for weight control
  • Allergies or dietary restrictions that would prevent consumption of foods used in the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Temple University

    Philadelphia, Pennsylvania, 19122-6091

Other trials in United States

About this study

Enhancing children's sleep may be a novel approach for prevention of obesity and cardiovascular (CV) disturbance. Observational studies with children demonstrate that short sleep increases risk of obesity and other CV risk factors. Randomized controlled trials with children 8-11 years old demonstrate that enhancing sleep duration leads to positive changes in eating and activity behaviors and weight status, particularly for children who enhance their sleep the most. Enhancing sleep may be particularly important for racial minority children and those from lower socioeconomic backgrounds given their increased risk for short sleep, obesity and CV risk factors. In this study two active obesity preventive interventions will be evaluated: a) enhancing sleep alone (Optimize Sleep [OS]), and b) enhancing sleep along with eating and activity behaviors that have demonstrated efficacy for obesity prevention and are implicated in self-regulatory pathways related to sleep (i.e., energy dense snack foods and beverages, TV viewing, and physical activity) (OS-Plus). Two hundred four children 6-11 years old who are primarily African American/black, primarily from low socioeconomic backgrounds, and who sleep < 9.5 hours/night into a 12-month study will be enrolled. Children will be randomly assigned to either OS or OS-Plus. Over the 6-month treatment phase, all children will attend an 8-session treatment; monthly phone contacts will occur during maintenance (6-12 months). Primary aim is to determine the efficacy of OS-Plus relative to OS on change in body mass index z-score (BMIz) at end of treatment. Secondary aims will assess efficacy of OS-Plus relative to OS on additional cardiometabolic risk factors, eating and activity behaviors. Exploratory aims will assess maintenance of effects at 12 months.

Conditions
Obesity, Sleep
Being tested
Optimize Sleep (OS), Optimize Sleep-Plus (OS-Plus)
Keywords
obesity prevention, sleep, behavioral intervention
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimize Sleep (OS)Behavioural

    All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 "sleep challenges" (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact.

  • Optimize Sleep-Plus (OS-Plus)Behavioural

    All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 "sleep challenges" (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact.

Study groups in NCT03186508
Study groupRoleWhat they receive
Optimize Sleep (OS)Active comparatorOptimize Sleep will focus exclusively on enhancing sleep by using effective behavioral strategies. Specific strategies to be used include: goal setting and self-monitoring, positive bedtime routines, stimulus control/sleep hygiene strategies, problem-solving regarding challenges, and review of effective strategies for relapse prevention.
Receives: Behavioral: Optimize Sleep (OS)
Optimize Sleep-Plus (OS-Plus)Active comparatorOS-Plus will focus on enhancing sleep and targeted eating (decreasing sugar-sweetened beverages and sweet and salty snack foods) and activity (increasing physical activity and decreasing TV viewing) behaviors. Specific strategies to be used include: goal setting and self-monitoring, positive bedtime routines, stimulus control/sleep hygiene strategies, problem-solving regarding challenges, and review of effective strategies for relapse prevention.
Receives: Behavioral: Optimize Sleep-Plus (OS-Plus)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BMIz

    change in body mass index z-score (accounting for child age and sex)

    Measured: Change from baseline BMIz at 6 months

Secondary outcomes (11)

  1. Change in Body Composition

    change in body composition (% body fat) will be estimated by air displacement plethysmography (BOD POD®; Life Measurement Instruments, Concord, CA)

    Measured: Change from baseline percent body fat at 6 months

  2. Change in Waist Circumference

    Change in measured waist circumference

    Measured: Change from baseline waist circumference at 6 months

  3. Change in Insulin Resistance

    Change in the homeostatic model assessment of insulin resistance (HOMA-IR)

    Measured: Change from baseline HOMA-IR at 6 months

  4. Change in Blood Glucose Levels

    2-hour blood glucose levels measured within the context of an oral glucose tolerance test

    Measured: Change from baseline blood glucose levels at 6 months

  5. Change in Non-HDL cholesterol (non-HDL-C)

    Total cholesterol (TC) minus HDL-C, includes LDL-C, VLDL-C, and atherogenic apo-B containing lipoproteins

    Measured: Change from baseline in Non-HDL-C at 6 months

  6. Change in Insulin Sensitivity Index (ISI)

    Insulin Sensitivity Index measured within the context of an oral glucose tolerance test

    Measured: Change from baseline ISI at 6 months

  7. Change in Sleep Period

    Wrist-worn actigraphy

    Measured: Change from baseline in the sleep period at 6 months

  8. Change in Caloric Intake

    24-hr dietary recalls on two days used to estimate caloric intake

    Measured: Change from baseline in caloric intake at 6 months

  9. Change in Food Reinforcement

    Measured using a validated computer activity (Behavioral Choice Task), which assesses motivation for a food reward

    Measured: Change from baseline in food reinforcement at 6 months

  10. Change in Eating in the Absence of Hunger (EAH)

    Food consumed within the context of the eating in the absence of hunger paradigm

    Measured: Change from baseline in EAH at 6 months

  11. Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)

    Waist-worn accelerometer

    Measured: Change from baseline in MVPA at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2017
  2. Study start28 Feb 2018
  3. Primary completion1 Mar 2023
  4. Study completion19 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03186508
Sponsor's protocol ID
R01HL092910
Other IDs
R01HL092910
Status last verified
Jan 2024
First submitted
31 Mar 2017
Last updated
28 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Spaeth AM, Hawley NL, Raynor HA, Jelalian E, Greer A, Crouter SE, Coffman DL, Carskadon MA, Owens JA, Wing RR, Hart CN. Sleep, energy balance, and meal timing in school-aged children. Sleep Med. 2019 Aug;60:139-144. doi: 10.1016/j.sleep.2019.02.003. Epub 2019 Feb 16.

    PubMed 30905623

Questions about this trial

What is this clinical trial studying?

A study testing Optimize Sleep (OS) and Optimize Sleep-Plus (OS-Plus) in people with Obesity and Sleep, run by Temple University 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 7 inclusion and 4 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 28 Oct 2024. 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?

Change in BMIz (time frame: Change from baseline BMIz at 6 months). 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 NCT03186508, which also lists 1 linked publication.

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 28 Oct 2024; AzTrials last refreshed its copy on 30 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in