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

Not Applicable

Active, not recruiting

• Conditions: Adolescent Overweight; Adolescent Obesity; Sleep; Eating Behaviors; Dietary Intake

• Registration Number: NCT06745570
• Lead Sponsor: Drexel University

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).

Study Timeline

• Study Start: 2024-04-18
• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-06-15
• Study Completion: 2027-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percent of 95th percentile BMI	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	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	From enrollment to the end of the study (approximately 4 months)	Body fat percentage will also be derived from the Aria Air scale.

Secondary Outcome Measures

Name	Time	Method
Dietary intake	From enrollment to the end of the study (approximately 4 months)	Adolescent dietary intake will be assessed via 30-day dietary recalls using the VioScreen at the baseline and post-treatment assessments. This freely available and validated web-based tool enables automated, self-administered, 30-day recalls. The VioScreen provides item-level nutritional information as well as monthly totals of key nutrient variables. Mean intake of the following food/macronutrient groups will be calculated: fruits and vegetables, fat, saturated fat, protein, cholesterol, added sugars, and dietary fiber.
Eating Disorder Examination	From enrollment to the end of the study (approximately 4 months)	The investigators will also assess adolescent eating behaviors using the Binge Module and the Compensatory Behaviors Module portions of the Eating Disorder Examination at each assessment point.
Eating Disorder Examination Questionnaire	From enrollment to the end of the study (approximately 4 months)	The investigators will have adolescents and their parents complete the Eating Disorder Examination Questionnaire, a self-report measure of eating behaviors, and baseline and post-treatment.
Average total sleep time	From enrollment to the end of the study (approximately 4 months)	Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average total sleep time will be calculated.
Average bed time	From enrollment to the end of the study (approximately 4 months)	Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average bed time will be calculated.
Average sleep latency	From enrollment to the end of the study (approximately 4 months)	Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average sleep latency will be calculated.
Average weekday-weekend bed time shift	From enrollment to the end of the study (approximately 4 months)	Adolescent sleep diaries will be collected for a 1-week period prior to the initiation of the intervention, 1 week at mid-intervention and 1 week following the intervention. Average weekday-weekend bed time shift will be calculated.
Pittsburgh Sleep Quality Index	From enrollment to the end of the study (approximately 4 months)	Adolescents and their parents will complete the Pittsburgh Sleep Quality Index, a well-validated overall measure of sleep quality, at each assessment point.
Morningness Eveningness Questionnaire	From enrollment to the end of the study (approximately 4 months)	The investigators will use the Morningness Eveningness Questionnaire at each assessment point to assess differences in the degree to which adolescents are active and alert at certain times of the day.
Insomnia Severity Index	From enrollment to the end of the study (approximately 4 months)	The investigators will have participants complete the Insomnia Severity Index to assess insomnia.
Sleep - Fitbit data	From enrollment to the end of the study (approximately 4 months)	Participants will wear a FitBit during the assessment weeks, which will gather accelerometry data on sleep.

Trial Locations

Locations (1)

Drexel University WELL Center; 🇺🇸 Philadelphia, Pennsylvania, United States