Improving Sleep as a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Percent of 95th percentile BMI
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Group Intervention
All participants will receive group-based lifestyle modification and sleep treatment (16, 90-minute sessions over 16 weeks). All sessions will be delivered on Zoom (remotely) to small groups (n=5-10 each) of participants. The intervention involves lifestyle modification content (e.g., nutritional education, physical activity education, stimulus control, goal setting) and sleep content (e.g., psychoeducation regarding sleep and eating behavior, sleep tracking, establishing regular sleep-wake times).
干预措施: Lifestyle Modification and Sleep Intervention (Behavioral)
结局指标
主要结局
Percent of 95th percentile BMI
时间窗: From enrollment to the end of the study (approximately 4 months)
Height and weight will be measured at each assessment and used to calculate percent of 95th percentile BMI.
Tri-ponderal mass index
时间窗: From enrollment to the end of the study (approximately 4 months)
The investigators will also calculate tri-ponderal mass index (TMI; i.e., mass divided by height cubed) from measurements of height and weight.
Body fat percentage
时间窗: From enrollment to the end of the study (approximately 4 months)
Body fat percentage will also be derived from the Aria Air scale.
次要结局
- Dietary intake(From enrollment to the end of the study (approximately 4 months))
- Eating Disorder Examination(From enrollment to the end of the study (approximately 4 months))
- Eating Disorder Examination Questionnaire(From enrollment to the end of the study (approximately 4 months))
- Average total sleep time(From enrollment to the end of the study (approximately 4 months))
- Average bed time(From enrollment to the end of the study (approximately 4 months))
- Average sleep latency(From enrollment to the end of the study (approximately 4 months))
- Average weekday-weekend bed time shift(From enrollment to the end of the study (approximately 4 months))
- Pittsburgh Sleep Quality Index(From enrollment to the end of the study (approximately 4 months))
- Morningness Eveningness Questionnaire(From enrollment to the end of the study (approximately 4 months))
- Insomnia Severity Index(From enrollment to the end of the study (approximately 4 months))
- Sleep - Fitbit data(From enrollment to the end of the study (approximately 4 months))
研究者
Stephanie Manasse
Research Scientist
Nemours Children's Clinic