Behavioral Sleep Intervention for Childhood Obesity

(Rx SLEEP Trial)

Overseen By Chantelle N Hart, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Temple University

Disqualifiers: Sleep disorder, Medical condition, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 6 months

50 Participants Needed

Trial Summary

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?

Research shows that longer sleep duration is linked to greater reductions in BMI (a measure of body fat based on height and weight) among obese adolescents and preschoolers. This suggests that improving sleep could be an effective part of managing childhood obesity. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{2 4 9 10 11}

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.

Research Team

Chantelle N Hart, PhD

Principal Investigator

Temple University

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.

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)

Trial Overview The 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

Group I: Sleep Education Experimental Treatment 1 Intervention

Sleep Education

Group II: Behavioral Sleep Intervention Experimental Treatment 1 Intervention

Behavioral intervention to enhance school-aged children's sleep

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

In a study of 151 preschool-age children with obesity, a family-based weight-management intervention did not significantly change sleep duration or bedtime compared to standard care, indicating that sleep health may need more focused strategies in such programs.

However, earlier bedtimes and longer sleep duration were linked to lower body mass index z scores (BMIz) and reduced intake of added sugars, suggesting that improving sleep habits could positively impact weight management and dietary choices in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep duration and bedtime in preschool-age children with obesity: Relation to BMI and diet following a weight management intervention. Simon, SL., Goetz, AR., Meier, M., et al.[2020]

The US medical system currently struggles to effectively address childhood obesity, with primary care practices often not aligning with evidence-based recommendations for prevention and treatment.

Collaboration between childhood obesity specialists and primary care providers has shown promise in improving the quality of care for obesity prevention and treatment, highlighting the importance of systematic approaches to tackle this issue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Building capacity for childhood obesity prevention and treatment in the medical community: call to action. Haemer, M., Cluett, S., Hassink, SG., et al.[2022]

In a study of 41 obese preschool-aged children enrolled in a weight management program, longer nocturnal sleep duration was linked to lower body mass index (BMI) after treatment, suggesting that better sleep may help reduce obesity in young children.

The research also found that increased sleep duration was associated with lower caloric intake, indicating that adequate sleep could play a crucial role in managing weight and eating habits in preschoolers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between sleep duration and weight in treatment-seeking preschoolers with obesity. Clifford, LM., Beebe, DW., Simon, SL., et al.[2021]

Establishing consistent bedtime routines and creating a conducive sleep environment are effective strategies for improving sleep in children, which may help prevent obesity.

Health care professionals can play a crucial role in educating parents about sleep strategies early in a child's life, potentially reducing the risk of obesity and its associated long-term health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An integrative review of sleep interventions and related clinical implications for obesity treatment in children. Fenton, K., Marvicsin, D., Danford, CA.[2016]

In a study of 83 obese adolescents, those who reported getting more sleep during the week were more likely to experience a reduction in BMI after 3 months in a weight management program.

Adolescents who lost at least 1 kg/m² in BMI reported an average of 60.7 hours of sleep per week, compared to 56.4 hours for those with less weight loss, suggesting that improving sleep duration could be beneficial for weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longer weekly sleep duration predicts greater 3-month BMI reduction among obese adolescents attending a clinical multidisciplinary weight management program. Sallinen, BJ., Hassan, F., Olszewski, A., et al.[2021]

A study involving 398 American Indian children aged 2-5 years found that longer overnight sleep duration is significantly associated with lower BMI z-scores, indicating a potential protective effect against obesity.

Children who slept 12 or more hours per night had significantly lower BMI z-scores compared to those who slept 8 to 10 hours or less than 8 hours, suggesting that adequate sleep may be an important factor in preventing obesity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overnight sleep duration and obesity in 2-5 year-old American Indian children. Ingram, DG., Irish, LA., Tomayko, EJ., et al.[2022]

A systematic review of 22 papers identified 12 effective interventions for treating overweight and obese children in primary care settings, emphasizing the importance of training healthcare professionals before delivering these interventions.

Successful interventions included a combination of behavior change strategies such as counseling, education, and tailored support, which can be practical for future studies aimed at addressing childhood obesity in primary care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Components of primary care interventions to treat childhood overweight and obesity: a systematic review of effect. Sargent, GM., Pilotto, LS., Baur, LA.[2022]

A pilot implementation study of a structured lifestyle intervention for overweight children aged 6-8 years showed a significant decrease in BMI z-score by 5.6%, indicating the intervention's effectiveness in a primary care setting.

Despite the positive outcomes, challenges in implementation were noted, with 35% of children discontinuing the program and only 50% of physicians continuing to apply at least one component of the intervention after the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating a childhood obesity program with the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Lew, MS., L'Allemand, D., Meli, D., et al.[2020]

Children and adolescents with obesity reported shorter sleep duration and poorer sleep behaviors compared to their normal-weight peers, indicating a significant relationship between obesity and sleep quality.

Psychological factors such as anxiety and depression were found to be moderate predictors of unfavorable sleep outcomes, suggesting that these issues may need to be addressed in treatment programs for childhood obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Childhood Obesity and Psychological Factors on Sleep. Mazurak, N., Cook, J., Weiland, A., et al.[2021]

Insufficient sleep in infancy and early childhood is linked to an increased risk of overweight and obesity, highlighting the importance of sleep duration in childhood health.

Interventions designed to improve sleep quality and quantity may be effective strategies for preventing childhood obesity, although more research is needed to fully understand the mechanisms involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Ash, T., Taveras, EM.[2022]

Family-based behavioral interventions are effective and safe for treating childhood obesity and should be prioritized as a first-line treatment option.

Primary care providers play a crucial role in identifying childhood obesity early and referring families to evidence-based treatments, emphasizing the importance of comprehensive, family-involved strategies for successful long-term management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. Coppock, JH., Ridolfi, DR., Hayes, JF., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Sleep duration and bedtime in preschool-age children with obesity: Relation to BMI and diet following a weight management intervention. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Building capacity for childhood obesity prevention and treatment in the medical community: call to action. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The association between sleep duration and weight in treatment-seeking preschoolers with obesity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

An integrative review of sleep interventions and related clinical implications for obesity treatment in children. [2016]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Longer weekly sleep duration predicts greater 3-month BMI reduction among obese adolescents attending a clinical multidisciplinary weight management program. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Overnight sleep duration and obesity in 2-5 year-old American Indian children. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Components of primary care interventions to treat childhood overweight and obesity: a systematic review of effect. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating a childhood obesity program with the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Childhood Obesity and Psychological Factors on Sleep. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

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]

11. United States pubmed.ncbi.nlm.nih.gov

Current approaches to the management of pediatric overweight and obesity. [2021]