Clinical trial NCT06745570: Improving Sleep, Decision-Making, and Eating in Adolescents with Obesity
Official title: Improving Sleep As a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents with Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Adolescent Overweight
Adolescent Obesity
Sleep
Eating Behaviors
Dietary Intake
Keywords: Adolescent Weight Loss
Adolescent Sleep
Adolescent Eating
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-12-20
Enrollment: 50
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Percent of 95th percentile BMI
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Tri-ponderal mass index
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Body fat percentage
timeFrame: From enrollment to the end of the study (approximately 4 months)
Secondary outcomes:
measure: Dietary intake
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Eating Disorder Examination
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Eating Disorder Examination Questionnaire
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Average total sleep time
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Average bed time
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Average sleep latency
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Average weekday-weekend bed time shift
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Pittsburgh Sleep Quality Index
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Morningness Eveningness Questionnaire
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Insomnia Severity Index
timeFrame: From enrollment to the end of the study (approximately 4 months)
measure: Sleep - Fitbit data
timeFrame: From enrollment to the end of the study (approximately 4 months)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University WELL Center
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Stephanie Manasse, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: