[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06810557":3,"trial-entities:NCT06810557":136,"trial-summary:NCT06810557":140},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":48,"secondary_outcomes":69,"sex":88,"minimum_age":89,"maximum_age":90,"healthy_volunteers":91,"eligibility_criteria":92,"std_ages":106,"locations":108,"central_contacts":124,"overall_officials":131,"references":134,"see_also_links":135},"NCT06810557","R01DK139665","Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care","Feasibility and Preliminary Efficacy of a Brief Behavioral Sleep Intervention for Excessive Weight Gain Prevention in Primary Care","RECRUITING","2027-03-31","2026-02","2026-02-12","2025-05-15","Temple University","OTHER",true,"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.","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 (\\\u003C 9 hours\u002Fnight) children 6-11 years old who are primarily AA\u002FBlack 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).",[19,20,21],"Obesity, Childhood","Short Sleep","Obesity Prevention",[23,24,25,26,27,28],"sleep","behavioral intervention","primary care","obesity prevention","child","pediatric","INTERVENTIONAL","PREVENTION",[32],"NA",{"count":34,"type":35},50,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"BEHAVIORAL","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\u002Fnight.",[42],"Behavioral Sleep Intervention",{"type":14,"name":44,"description":45,"armGroupLabels":46},"Enhanced Usual Care","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.",[47],"Sleep Education",[49,53,56,60,63,66],{"measure":50,"description":51,"timeFrame":52},"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.","baseline",{"measure":54,"description":55,"timeFrame":52},"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.",{"measure":57,"description":58,"timeFrame":59},"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.","baseline to 6 months",{"measure":61,"description":62,"timeFrame":59},"Nurse percent fidelity\u002Faccuracy 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\u002Faccuracy.",{"measure":64,"description":65,"timeFrame":59},"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.",{"measure":67,"description":68,"timeFrame":59},"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.",[70,73,76,79,82,85],{"measure":71,"description":72,"timeFrame":59},"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.",{"measure":74,"description":75,"timeFrame":59},"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.",{"measure":77,"description":78,"timeFrame":59},"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.",{"measure":80,"description":81,"timeFrame":59},"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.",{"measure":83,"description":84,"timeFrame":59},"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.",{"measure":86,"description":87,"timeFrame":59},"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.","ALL","6 Years","11 Years",false,{"inclusion":93,"exclusion":101,"raw_text":105},[94,95,96,97,98,99,100],"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",[102,103,104],"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","Inclusion Criteria:\n\n* Patient at Temple Pediatrics\n* Child age 6-11 years\n* Child time in bed of less than 9 hours per night on most days per week\n* Body Mass Index (BMI) for age and biological sex great than the 10th percentile but less than the 95th percentile\n* Understanding of and ability to complete the protocol\n* Parent age at least 18 years and primary caregiver\n* Willingness to be randomized to either condition\n\nExclusion Criteria:\n\n* Diagnosed sleep disorder\n* Medication use or diagnosis of medical or psychiatric condition that may impact sleep or weight status\n* Current or planned treatment for weight control",[107],"CHILD",[109],{"facility":110,"status":8,"city":111,"state":112,"zip":113,"country":114,"contacts":115,"geoPoint":121},"Temple Pediatrics","Philadelphia","Pennsylvania","19140","United States",[116],{"name":117,"role":118,"phone":119,"email":120},"Ashley Ogoe, MPH","CONTACT","215-707-5782","ashley.greer@temple.edu",{"lat":122,"lon":123},39.95238,-75.16362,[125,127],{"name":126,"role":118,"phone":119,"email":120},"Ashley Ogoe, MPH, CCRP",{"name":128,"role":118,"phone":129,"email":130},"Chantelle N Hart, PhD","215-707-8639","chantelle.hart@temple.edu",[132],{"name":128,"affiliation":13,"role":133},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":137,"biomarkers":139},[138],"Obesity",[],{"nct_id":4,"found":15,"summary":141,"prompt_version":151},{"design":142,"status":143,"heading":144,"summary":145,"follow_up":146,"word_count":147,"commitments":148,"compensation":149,"drugs_mentioned":150},"This interventional study plans to enroll 50 children who will be randomly assigned to one of two groups. It is not specified if the study is blinded.","completed","Brief Behavioral Sleep Intervention for Childhood Obesity Prevention","This study is looking at two ways to help children aged 6-11 improve their sleep and prevent obesity. One group will receive \"Optimize Sleep Primary Care (OSPC)\", which involves working with a nurse through Zoom and phone calls to learn sleep strategies. The other group will receive \"Enhanced Usual Care,\" which provides educational materials about children's sleep. The study aims to see if these approaches help children sleep better and how many families and providers participate. We don't know the current status of recruitment, but the study plans to enroll 50 children. To join, children must be patients at Temple Pediatrics, aged 6-11, sleep less than 9 hours per night, and have a BMI between the 10th and 95th percentile. Parents must be at least 18 and willing to participate.","Participants will be followed for 6 months after the start of the study.",130,"Participating families will have 6 contacts with a nurse or receive 6 educational handouts over 6 months. They will also complete three assessments, including questionnaires, wearing sleep\u002Factivity devices, reporting food intake, and having height and weight measured.","Not stated in the trial record.",[39,44],"v2"]