Improving Sleep, Decision-Making, and Eating in Adolescents With Obesity

Официальное название

Improving Sleep as a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents With Obesity

Обзор

This study is being performed to understand the effects of a lifestyle modification and sleep intervention on weight loss outcomes in adolescence. The main question the study aims to answer is: \- What are the initial effects of a lifestyle modification and sleep intervention, including effects on weight, eating behaviors and dietary intake, and sleep? Participants will: * Participate in remote, group-based, weekly weight loss and sleep coaching for 16 weeks. * Complete study assessments at baseline (pre-intervention), mid-intervention, and post-intervention. * Complete daily sleep diaries for three 7-day periods at each assessment point.

Подробное описание

In this study, the investigators will develop, refine, and test a 16-session group-based lifestyle modification intervention for adolescents with overweight and obesity augmented with a sleep intervention. The investigators will develop the manual and pilot the intervention in an initial set of adolescents (n=10). The investigators will collect feedback from adolescents, parents, and clinicians, which will inform manual refinements. The investigators will complete an open trial (n=40) of the refined manual. For both phases, the investigators will recruit adolescents (ages 14-18) with overweight or obesity who endorse at least 1 type of sleep disturbance (i.e., too little, poor quality, poorly timed, or inconsistent sleep). Assessments of sleep, decision-making, problematic eating behaviors, energy intake, and weight will occur at baseline (week 0), mid-intervention (week 8) and post-intervention (week 16).

Вмешательства

• Поведенческое Lifestyle Modification and Sleep Intervention
  This study is being performed to develop, refine, and test the effects of a group lifestyle modification intervention augmented with a sleep intervention on weight loss, eating behaviors, and sleep outcomes. Results from this study will inform future studies to test the efficacy of this intervention. This intervention is being offered as part of a research study within Drexel University's WELL Center. Participants will receive remote, group-based, weekly weight loss and sleep coaching (90 minute

Первичные конечные точки

• Percent of 95th percentile BMI [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Tri-ponderal mass index [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Body fat percentage [Срок оценки: From enrollment to the end of the study (approximately 4 months)]

Вторичные конечные точки (11)

• Dietary intake [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Eating Disorder Examination [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Eating Disorder Examination Questionnaire [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Average total sleep time [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Average bed time [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Average sleep latency [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Average weekday-weekend bed time shift [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Pittsburgh Sleep Quality Index [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Morningness Eveningness Questionnaire [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Insomnia Severity Index [Срок оценки: From enrollment to the end of the study (approximately 4 months)]
• Sleep - Fitbit data [Срок оценки: From enrollment to the end of the study (approximately 4 months)]

Критерии участия

Критерии включения

• Ages 14-18
• Fluent in English
• BMI percentile ≥ 85th percentile for sex-and-age
• Has a parent or guardian who is willing and able to participate
• Has at least one sleep disturbance. Eligible sleep disturbances are: a. Advanced sleep timing (sleep onset 11:00pm or later for 14-16 year-olds or 11:20pm or later for 17-18 year-olds at least 3 times per week), b. Difficulty falling asleep (taking ≥ 30 mins to get to sleep 3 or more nights per week), c. Short sleep (obtaining < 7.5 hours of sleep per night 3 or more nights per week), and d. Sleep irregularity (having more than 2 hours of variability in sleep-wake schedule across one week

Критерии исключения

• Experience of weight loss of ≥ 5% of body weight in the past 6 months
• Current use of insomnia medication
• Having recently begun or changed the dosage of any medication known to affect appetite or body composition within the last 3 months
• Currently taking weight loss medications
• Currently taking insulin
• Diagnosed diabetes (type 1)
• Any condition prohibiting physical activity
• Diagnosis of an eating disorder
• Diagnosis of obstructive sleep apnea
• Recent or ongoing problem with drug abuse, alcohol abuse, or addiction
• Currently pregnant or less than 3 months postpartum
• Anticipation of a possible pregnancy in the next year
• Unwillingness to report possible or confirmed pregnancies promptly during the course of the trial
• Currently participating in treatment for eating or weight concerns
• Does not have regular access to Wi-Fi connection to participate in study interventions.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Nemours Children's Clinic — Wilmington

Идентификаторы

NCT: NCT06745570 · 2310010117 · R03DK138216

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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