Behavioral Sleep Intervention for Childhood Obesity
(Rx SLEEP Trial)
Recruiting in Palo Alto (17 mi)
Overseen byChantelle N Hart, PhD
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Temple University
Disqualifiers: Sleep disorder, Medical condition, Psychiatric condition, others
No Placebo Group
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes participants who use medications that may impact sleep or weight status.
What data supports the effectiveness of the treatment Optimize Sleep Primary Care (OSPC) for childhood obesity?
Is the Behavioral Sleep Intervention for Childhood Obesity safe for children?
The research articles reviewed do not provide specific safety data for the Behavioral Sleep Intervention for Childhood Obesity or its related programs like Optimize Sleep Primary Care (OSPC). However, they focus on the effectiveness and implementation of interventions in primary care settings, suggesting that these interventions are generally considered safe for use in children.24678
How does the Optimize Sleep Primary Care (OSPC) treatment differ from other treatments for childhood obesity?
The Optimize Sleep Primary Care (OSPC) treatment is unique because it focuses on improving sleep quality and duration as a way to prevent and manage childhood obesity, which is not typically addressed in standard obesity treatments. This approach leverages the relationship between sleep and weight, aiming to integrate sleep interventions into primary care settings to enhance overall treatment effectiveness.2491011
Eligibility Criteria
This trial is for children aged 6-11 who sleep less than 9 hours most nights, have a BMI between the 10th and 95th percentile for their age and sex, and are patients at Temple Pediatrics. Their parents must be over 18, primary caregivers, willing to follow the study's procedures, and open to being randomly assigned to one of two groups.Inclusion Criteria
I am a patient at Temple Pediatrics.
My child is between 6 and 11 years old.
My child sleeps less than 9 hours most nights.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Families receive either a behavioral sleep intervention or sleep education over 6 months
6 months
6 sessions (combination of in-person, virtual, and phone follow-ups)
Follow-up
Participants are monitored for changes in sleep, diet, physical activity, and weight status
4 weeks
2 visits (in-person)
Treatment Details
Interventions
- Optimize Sleep Primary Care (OSPC) (Behavioural Intervention)
Trial OverviewThe study compares two methods aimed at improving children's sleep: personalized coaching from a nurse on behavioral strategies or receiving educational materials about good sleep practices. Families will engage in six sessions with assessments at the start, after two months, and six months including questionnaires, activity monitoring devices worn by children, dietary reports, and height/weight measurements.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Sleep EducationExperimental Treatment1 Intervention
Sleep Education
Group II: Behavioral Sleep InterventionExperimental Treatment1 Intervention
Behavioral intervention to enhance school-aged children's sleep
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Temple PediatricsPhiladelphia, PA
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Who Is Running the Clinical Trial?
Temple UniversityLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
Sleep duration and bedtime in preschool-age children with obesity: Relation to BMI and diet following a weight management intervention. [2020]Sleep duration is associated with obesity in preschoolers. Weight-management interventions may be an opportunity to incorporate sleep health recommendations.
Building capacity for childhood obesity prevention and treatment in the medical community: call to action. [2022]Large gaps exist in the capacity of the US medical system to participate meaningfully in childhood obesity-prevention efforts and to meet the treatment needs of obese children. Current primary care practice for the prevention and treatment of childhood obesity often varies from evidence-based recommendations. Childhood obesity specialists have partnered successfully with schools of medicine, professional societies, and other organizations to collaboratively engage with primary care providers in quality improvement for obesity prevention and treatment. This review and commentary targets 2 audiences. For childhood obesity experts and their organizational partners, methods to support change in primary practice and the evidence supporting their use are outlined. For primary care providers and non-obesity specialists, effective strategies for changing practice and the potential benefits of addressing childhood obesity systematically are discussed.
The association between sleep duration and weight in treatment-seeking preschoolers with obesity. [2021]To examine the association between nocturnal sleep duration and weight and caloric intake outcomes among preschool-aged children who are obese and enrolled in a family-based weight management program.
An integrative review of sleep interventions and related clinical implications for obesity treatment in children. [2016]Evidence has shown correlations between obesity and sleep in children. The purpose of this review was to identify sleep interventions that could be utilized in primary care settings to prevent obesity in children.
Longer weekly sleep duration predicts greater 3-month BMI reduction among obese adolescents attending a clinical multidisciplinary weight management program. [2021]To determine whether baseline levels of self-reported sleep and sleep problems among obese adolescents referred to an outpatient multidisciplinary family-based weight management program predict reduction in BMI 3 months later.
Overnight sleep duration and obesity in 2-5 year-old American Indian children. [2022]Sleep has emerged as a potentially modifiable risk factor for obesity in children.
Components of primary care interventions to treat childhood overweight and obesity: a systematic review of effect. [2022]The primary care setting presents an opportunity for intervention of overweight and obese children but is in need of a feasible model-of-care with demonstrated effectiveness. The aims were to (i) identify controlled interventions that treated childhood overweight or obesity in either a primary care setting or with the involvement of a primary healthcare professional and (ii) examine components of those interventions associated with effective outcomes in order to inform future intervention trials in primary care settings. Major health and medicine databases were searched: MEDLINE, CINAHL, EMBASE, Cochrane Reviews, CENTRAL, DARE, PsychINFO and ERIC. Articles were excluded if they described primary prevention interventions, involved surgical or pharmacological treatment, were published before 1990 or not published in English. Twenty-two papers describing 17 studies were included. Twelve studies reported at least one significant intervention effect. Comparison of these 12 interventions provides evidence for: training for health professionals before intervention delivery; behaviour change options (including healthy diet, activity and sedentary behaviour); effecting behaviour change via a combination of counselling, education, written resources, support and motivation; and tailoring intensity according to whether behavioural, anthropometric or metabolic changes are the priority. These components are practicable to future intervention studies in primary care.
Evaluating a childhood obesity program with the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. [2020]Primary care providers can use behavioral lifestyle interventions to effectively treat children with overweight and obesity, but implementing these interventions is challenging. Most childhood obesity intervention evaluation studies focus on effectiveness. Few studies describe implementation. Our goal was to evaluate critical components of a childhood obesity intervention in primary care. We conducted a pilot implementation study of an existing structured lifestyle intervention in the Canton of Bern, Switzerland from 2013 to 2015. The intervention consisted of 10 sessions, led by a primary care physician. It included children aged 6-8 years old, with BMI over the 90th age-adjusted percentile. We used the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) evaluation framework to describe the pilot implementation study. We stratified description of RE-AIM components at the patient- and physician-level. For Reach: 864 children were screened; 65 were overweight; 394 physicians were invited to participate in the study. For Effectiveness: BMI z-score significantly decreased (-5.6%, p = 0.01). For Adoption: 14 participating physicians treated 26 patients. Implementation: the mean number of consultations was 8. For Maintenance: 9 (35%) children discontinued the intervention; 7 (50%) of physicians continued to apply at least one component of the intervention. The summarized components of the program within the RE-AIM framework suggest the program was successful. Stakeholders can use our results if they intend to disseminate and evaluate similar interventions in different settings.
Impact of Childhood Obesity and Psychological Factors on Sleep. [2021]The aim of the study was to analyze sleep duration and behaviors in relation to psychological parameters in children and adolescents with obesity seeking inpatient weight-loss treatment in comparison to normal-weight children, and whether or not these variables would improve during the time course of treatment. Sixty children or adolescents with overweight and obesity (OBE) and 27 normal-weight (NW) peers (age: 9-17) were assessed for subjective sleep measures through self-reported and parent-reported questionnaires, as well as body weight, body composition, and psychological questionnaires. The OBE participants were assessed upon admission and before discharge of an inpatient multidisciplinary weight-loss program. NW participants' data were collected for cross-sectional comparison. In comparison to NW, children and adolescents with OBE had a shorter self-reported sleep duration and had poorer sleep behaviors and more sleep-disordered breathing as reported by their parents. No change in sleep measures occurred during the inpatient treatment. Psychological factors including higher anxiety, depression, and destructive-anger-related emotion regulation were moderate predictors for unfavorable sleep outcomes, independent of weight status. Children with obesity had less favorable sleep patterns, and psychological factors influenced sleep in children, independent of weight. More research is needed on the relationship and direction of influence between sleep, psychological factors, and obesity, and whether they can be integrated in the prevention and management of childhood obesity and possibly also other pediatric diseases.
Associations of short sleep duration with childhood obesity and weight gain: summary of a presentation to the National Academy of Science's Roundtable on Obesity Solutions. [2022]This article summarizes a presentation made in February 2017 as part of the National Academy of Sciences' Roundtable on Obesity Solutions webinar, "The Potential Role of Sleep in Obesity Prevention and Management: A Virtual Workshop." Briefly described are the patterns of childhood sleep duration in the United States, the state of the science relating insufficient sleep to overweight and obesity in infancy and early childhood, and the potential mechanisms for the association. Also discussed are intervention efforts to date. Despite research gaps, interventions aimed at increasing sleep quality and quantity may help prevent childhood obesity.
Current approaches to the management of pediatric overweight and obesity. [2021]Family-based behavioral intervention has been demonstrated to be an effective and safe treatment for childhood obesity and should be considered a first-line treatment option. However, access to such intensive evidence-based treatment is limited and, currently, obesity care is dominated by high intensity behavioral treatment implemented in specialty clinics or less effective low intensity treatments implemented in primary care. However, capitalizing on the established and ongoing relationship between primary care providers and families, primary care providers have an invaluable role in early identification of overweight and obesity, and subsequent referral to an evidence-based treatment. Key aspects of effective treatment include: early intervention, moderate intensity to high intensity intervention of sufficient duration, multicomponent intervention targeting dietary modification, physical activity and behavioral strategies, family involvement and goals targeting family members, and follow-up contact during maintenance. The purpose of this review is to present the current empirically supported treatment options for pediatric obesity including primary care-based interventions and diagnostic tools, multicomponent behavioral intervention with a focus on family-based behavioral intervention, immersion treatment, and pharmacologic and surgical management.