Brief Behavioral Sleep Intervention for Obesity Prevention in Primary Care

Официальное название

Feasibility and Preliminary Efficacy of a Brief Behavioral Sleep Intervention for Excessive Weight Gain Prevention in Primary Care

Обзор

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.

Подробное описание

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).

Вмешательства

• Поведенческое 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.
• Другое 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.

Первичные конечные точки

• Achievement of enrollment goal [Срок оценки: baseline]
• The number of providers who participate and refer to the intervention [Срок оценки: baseline]
• Average family attendance at intervention sessions [Срок оценки: baseline to 6 months]
• Nurse percent fidelity/accuracy in delivering the intervention [Срок оценки: baseline to 6 months]
• Percent of families who are retained in the study at both follow-up time points [Срок оценки: baseline to 6 months]
• Family assessment of the intervention's acceptability [Срок оценки: baseline to 6 months]

Вторичные конечные точки (6)

• Preliminary Effectiveness: Sleep [Срок оценки: baseline to 6 months]
• Preliminary Effectiveness: Weight Status [Срок оценки: baseline to 6 months]
• Preliminary Effectiveness: Diet - Caloric Intake [Срок оценки: baseline to 6 months]
• Preliminary Effectiveness: Diet - Percent Calories from Fat [Срок оценки: baseline to 6 months]
• Preliminary Effectiveness: Physical Activity [Срок оценки: baseline to 6 months]
• Preliminary Effectiveness: Sedentary Activity [Срок оценки: baseline to 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Temple Pediatrics — Philadelphia

Идентификаторы

NCT: NCT06810557 · R01DK139665 · R01DK139665

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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