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

Drexel University

Status: Active, not recruiting

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

Treatments: Behavioral: Lifestyle Modification and Sleep Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06745570

R03DK138216 (U.S. NIH Grant/Contract)

2310010117

Details and patient eligibility

About

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.

Full 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).

Enrollment: 50 estimated patients

Sex: All

Ages: 14 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Group Intervention

Experimental group

Description:

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).

Treatment:

Behavioral: Lifestyle Modification and Sleep Intervention