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临床试验/NCT03186508
NCT03186508已完成不适用

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

Temple University1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2018年2月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
149
试验地点
1
主要终点
Change in BMIz

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Optimize Sleep (OS)

Active Comparator

Optimize 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.

干预措施: Optimize Sleep (OS) (Behavioral)

Optimize Sleep-Plus (OS-Plus)

Active Comparator

OS-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.

干预措施: Optimize Sleep-Plus (OS-Plus) (Behavioral)

结局指标

主要结局

Change in BMIz

时间窗: Change from baseline BMIz at 6 months

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

次要结局

  • Change in Sleep Period(Change from baseline in the sleep period at 6 months)
  • Change in Body Composition(Change from baseline percent body fat at 6 months)
  • Change in Caloric Intake(Change from baseline in caloric intake at 6 months)
  • Change in Eating in the Absence of Hunger (EAH)(Change from baseline in EAH at 6 months)
  • Change in Percent Time spent in Moderate to Vigorous Physical Activity (MVPA)(Change from baseline in MVPA at 6 months)
  • Change in Waist Circumference(Change from baseline waist circumference at 6 months)
  • Change in Insulin Resistance(Change from baseline HOMA-IR at 6 months)
  • Change in Blood Glucose Levels(Change from baseline blood glucose levels at 6 months)
  • Change in Non-HDL cholesterol (non-HDL-C)(Change from baseline in Non-HDL-C at 6 months)
  • Change in Insulin Sensitivity Index (ISI)(Change from baseline ISI at 6 months)
  • Change in Food Reinforcement(Change from baseline in food reinforcement at 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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