Obesity, ChildhoodRx SLEEPNCT06810557
Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care
A study testing Optimize Sleep Primary Care (OSPC) in people with Obesity, Childhood and Short Sleep, run by Temple University at 1 site in United States.
Trial summary
The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Obesity, Childhood, Short Sleep, Obesity Prevention
- What is being tested?
- Optimize Sleep Primary Care (OSPC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Child
Who may be able to join
- Patient at Temple Pediatrics
- Child age 6-11 years
- Child time in bed of less than 9 hours per night on most days per week
- Body Mass Index (BMI) for age and biological sex great than the 10th percentile but less than the 95th percentile
- Understanding of and ability to complete the protocol
- Parent age at least 18 years and primary caregiver
- Willingness to be randomized to either condition
Who cannot join
- Diagnosed sleep disorder
- Medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status
- Current or planned treatment for weight control
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Temple Pediatrics
Philadelphia, Pennsylvania, 19140
Ashley Ogoe, MPH, 215-707-5782, ashley.greer@temple.edu
About this study
Official title: Feasibility and Preliminary Efficacy of a Brief Behavioral Sleep Intervention for Excessive Weight Gain Prevention in Primary Care
The goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Participating families will meet with a nurse 6 times or receive 6 educational handouts. Participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.
Read the detailed description
The present study is assessing the feasibility and preliminary effectiveness of a brief behavioral intervention to enhance children's sleep and prevent development of obesity. Fifty short sleeping (< 9 hours/night) children 6-11 years old who are primarily AA/Black and from lower socioeconomic backgrounds will be enrolled into a 6-month study. Children will be randomly assigned to 1 of 2 conditions: 1) optimize sleep primary care (OSPC; behavioral intervention to enhance sleep duration delivered by a nurse in primary care) or 2) enhanced usual care (EUC; usual care plus sleep education). All children will receive standard pediatric care. Families randomized to OSPC will receive a four-session intervention (two zoom-delivered sessions and two brief phone follow-ups) over the first two months with two additional phone follow-ups during maintenance (months 2-6). Families randomized to EUC will receive sleep education that is delivered at the same points of contact as OSPC sessions. At baseline, end of treatment (2 months), and 6 months, the following will be measured from a Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) perspective: reach (e.g., enrollment), adoption (e.g., pediatric provider engagement), implementation (e.g., session attendance, treatment fidelity), maintenance (e.g., retention), and preliminary effectiveness (e.g., changes in sleep duration (actigraphy), eating behaviors (24-hour dietary recalls), physical activity (accelerometry), and anthropometrics (measured height and weight).
- Conditions
- Obesity, Childhood, Short Sleep, Obesity Prevention
- Being tested
- Optimize Sleep Primary Care (OSPC), Enhanced Usual Care
- Keywords
- sleep, behavioral intervention, primary care, obesity prevention, child, pediatric
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optimize Sleep Primary Care (OSPC)Behavioural
In addition to standard care within Temple University Primary Care (TUPC), two face-to-face zoom sessions and four brief phone follow-ups (two during active treatment and two during maintenance) that focus on using effective behavioral strategies (e.g., goal setting, self-monitoring, positive reinforcement, stimulus control, problem-solving) to enhance children's sleep by approximately one hour/night.
Enhanced Usual CareOther
In addition to standard care within Temple University Primary Care (TUPC), the provision of six education contacts regarding children's sleep needs and the benefits of getting a good night's sleep.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Sleep Intervention | Experimental | Behavioral intervention to enhance school-aged children's sleep Receives: Behavioral: Optimize Sleep Primary Care (OSPC) |
| Sleep Education | Other | Sleep Education Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of enrollment goal
Primary variable of interest is achievement of a priori goals for study enrollment (i.e., whether 50 families enroll in the study). We will also explore: of children referred, the number who enroll; and of children who are referred and eligible, the number who enroll.
Measured: baseline
The number of providers who participate and refer to the intervention
Of all pediatric providers in the clinic, the number who attend the initial in-service training and the number of referrals each provider makes to the program. Attendance and the number of referrals will be tracked by study staff.
Measured: baseline
Average family attendance at intervention sessions
Whether or not families attend each treatment sessions will be captured by the study nurse. Primary variable of interest is whether families, on average, achieve > 75% attendance at all intervention sessions.
Measured: baseline to 6 months
Nurse percent fidelity/accuracy in delivering the intervention
All intervention sessions are recorded to determine the accuracy with which nurses deliver the intervention. Specifically, trained staff review recordings and use a checklist to mark whether or not each intervention component is delivered during each session. Primary variable of interest is whether the nurse delivers the intervention with at least 80% fidelity/accuracy.
Measured: baseline to 6 months
Percent of families who are retained in the study at both follow-up time points
Retention at both 2- and 6-months will be tracked by study staff and compared across study arms with a goal of at least 80% retention at two months.
Measured: baseline to 6 months
Family assessment of the intervention's acceptability
Acceptability will be measured by families' responses to the overall acceptability question on the Theoretical Framework for Acceptability (TFA) Acceptability Scale. Specifically, families use a 5-point, likert-type scale ranging from 'completely unacceptable' to 'completely acceptable' to rate the intervention. The percent of families who rate the intervention as 'acceptable' or 'completely acceptable' will be assessed with a goal of at least 80% of families rating it as such.
Measured: baseline to 6 months
Secondary outcomes (6)
Preliminary Effectiveness: Sleep
Measured with actigraphy over 7 days at each assessment and scored with the assistance of sleep diaries and call-ins to time-stamped voicemail. Primary variable of interest is change in the actigraph-estimated sleep period, which is the time between actigraph-estimated bedtime and wake time.
Measured: baseline to 6 months
Preliminary Effectiveness: Weight Status
Child height and weight will be measured by staff to calculate body mass index (BMI). Change in BMI (controlling for child age and biological sex) is of primary interest.
Measured: baseline to 6 months
Preliminary Effectiveness: Diet - Caloric Intake
Measured with 24-hour dietary recalls on two days (one weekday and one weekend day). Mean reported caloric intake will be computed.
Measured: baseline to 6 months
Preliminary Effectiveness: Diet - Percent Calories from Fat
Measured with 24-hour dietary recalls on two days (one weekday and one weekend day). Mean reported percent calories from fat will be computed.
Measured: baseline to 6 months
Preliminary Effectiveness: Physical Activity
Measured with hip-worn accelerometry. Time spent in moderate to vigorous physical activity (controlling for wear time) is of primary interest.
Measured: baseline to 6 months
Preliminary Effectiveness: Sedentary Activity
Measured by parent and child report during 24-hour dietary recalls (one weekday and one weekend day). Mean hours of TV viewing is of primary interest.
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start15 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chantelle N Hart, PhD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06810557
- Sponsor's protocol ID
- R01DK139665
- Other IDs
- R01DK139665
- Acronym
- Rx SLEEP
- Status last verified
- Feb 2026
- First submitted
- 21 Jan 2025
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified, cleaned and scored summary data of the following will be shared: parent-completed surveys, child-worn actigraph and accelerometry data, staff-measured parent and child height and weight data, and staff-tracked process data
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Preliminary Efficacy of a Brief Behavioral Sleep Intervention for Excessive Weight Gain Prevention in Primary Care
- ClinicalTrials.gov ID
- NCT06810557
- Acronym / sponsor ID
- Rx SLEEP / R01DK139665
- Conditions
- Obesity, Childhood, Short Sleep, Obesity Prevention
- Keywords
- sleep, behavioral intervention, primary care, obesity prevention, child, pediatric
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Feb 2025 (actual)
- 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 goal of this study is to compare two different approaches to help families with children 6-11 years enhance nighttime sleep: 1) working one-on-one with a nurse to learn effective behavioral strategies to try to improve children's sleep or 2) receiving education on a good night's sleep and its benefits. Participating families will meet with a nurse 6 times or receive 6 educational handouts. Participating families will also complete three assessments (start of the study, 2 months and 6 months) during which study questionnaires will be completed, participating children will wear devices that assess sleep and physical activity, participating families will report on what the child ate on two separate days and will be measured for height and weight.
Detailed description
The present study is assessing the feasibility and preliminary effectiveness of a brief behavioral intervention to enhance children's sleep and prevent development of obesity. Fifty short sleeping (< 9 hours/night) children 6-11 years old who are primarily AA/Black and from lower socioeconomic backgrounds will be enrolled into a 6-month study. Children will be randomly assigned to 1 of 2 conditions: 1) optimize sleep primary care (OSPC; behavioral intervention to enhance sleep duration delivered by a nurse in primary care) or 2) enhanced usual care (EUC; usual care plus sleep education). All children will receive standard pediatric care. Families randomized to OSPC will receive a four-session intervention (two zoom-delivered sessions and two brief phone follow-ups) over the first two months with two additional phone follow-ups during maintenance (months 2-6). Families randomized to EUC will receive sleep education that is delivered at the same points of contact as OSPC sessions. At baseline, end of treatment (2 months), and 6 months, the following will be measured from a Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) perspective: reach (e.g., enrollment), adoption (e.g., pediatric provider engagement), implementation (e.g., session attendance, treatment fidelity), maintenance (e.g., retention), and preliminary effectiveness (e.g., changes in sleep duration (actigraphy), eating behaviors (24-hour dietary recalls), physical activity (accelerometry), and anthropometrics (measured height and weight).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Sleep Intervention | Experimental | Behavioral: Optimize Sleep Primary Care (OSPC)Behavioral intervention to enhance school-aged children's sleep |
| Sleep Education | Other | Other: Enhanced Usual CareSleep Education |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Patient at Temple Pediatrics
- Child age 6-11 years
- Child time in bed of less than 9 hours per night on most days per week
- Body Mass Index (BMI) for age and biological sex great than the 10th percentile but less than the 95th percentile
- Understanding of and ability to complete the protocol
Key exclusion criteria (3 listed)
- Diagnosed sleep disorder
- Medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status
- Current or planned treatment for weight control
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 |
|---|---|---|
| Optimize Sleep Primary Care (OSPC)In addition to standard care within Temple University Primary Care (TUPC), two face-to-face zoom sessions and four brief phone follow-ups (two during active treatment and two during maintenance) that focus on using effective behavioral strategies (e.g., goal setting, self-monitoring, positive reinforcement, stimulus control, problem-solving) to enhance children's sleep by approximately one hour/night. | Behavioural | Behavioral Sleep Intervention |
| Enhanced Usual CareIn addition to standard care within Temple University Primary Care (TUPC), the provision of six education contacts regarding children's sleep needs and the benefits of getting a good night's sleep. | Other | Sleep Education |
Primary outcome
Achievement of enrollment goal
Time frame: baseline
Primary variable of interest is achievement of a priori goals for study enrollment (i.e., whether 50 families enroll in the study). We will also explore: of children referred, the number who enroll; and of children who are referred and eligible, the number who enroll.
The number of providers who participate and refer to the intervention
Time frame: baseline
Of all pediatric providers in the clinic, the number who attend the initial in-service training and the number of referrals each provider makes to the program. Attendance and the number of referrals will be tracked by study staff.
Average family attendance at intervention sessions
Time frame: baseline to 6 months
Whether or not families attend each treatment sessions will be captured by the study nurse. Primary variable of interest is whether families, on average, achieve > 75% attendance at all intervention sessions.
Nurse percent fidelity/accuracy in delivering the intervention
Time frame: baseline to 6 months
All intervention sessions are recorded to determine the accuracy with which nurses deliver the intervention. Specifically, trained staff review recordings and use a checklist to mark whether or not each intervention component is delivered during each session. Primary variable of interest is whether the nurse delivers the intervention with at least 80% fidelity/accuracy.
Percent of families who are retained in the study at both follow-up time points
Time frame: baseline to 6 months
Retention at both 2- and 6-months will be tracked by study staff and compared across study arms with a goal of at least 80% retention at two months.
Family assessment of the intervention's acceptability
Time frame: baseline to 6 months
Acceptability will be measured by families' responses to the overall acceptability question on the Theoretical Framework for Acceptability (TFA) Acceptability Scale. Specifically, families use a 5-point, likert-type scale ranging from 'completely unacceptable' to 'completely acceptable' to rate the intervention. The percent of families who rate the intervention as 'acceptable' or 'completely acceptable' will be assessed with a goal of at least 80% of families rating it as such.
6 secondary outcomes
Preliminary Effectiveness: Sleep
Time frame: baseline to 6 months
Preliminary Effectiveness: Weight Status
Time frame: baseline to 6 months
Preliminary Effectiveness: Diet - Caloric Intake
Time frame: baseline to 6 months
Preliminary Effectiveness: Diet - Percent Calories from Fat
Time frame: baseline to 6 months
Preliminary Effectiveness: Physical Activity
Time frame: baseline to 6 months
Preliminary Effectiveness: Sedentary Activity
Time frame: baseline to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified, cleaned and scored summary data of the following will be shared: parent-completed surveys, child-worn actigraph and accelerometry data, staff-measured parent and child height and weight data, and staff-tracked process data
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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.
Chantelle N Hart, PhD principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optimize Sleep Primary Care (OSPC) in people with Obesity, Childhood and Short 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 3 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: looking for participants now, as of the sponsor's last update on 12 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley Ogoe, MPH, CCRP (215-707-5782, ashley.greer@temple.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of enrollment goal (time frame: baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2026.