Improving Sleep, Decision-Making, and Eating in Adolescents with Obesity
NCT ID: NCT06745570
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
50 participants
INTERVENTIONAL
2024-04-18
2027-01-31
Brief Summary
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\- 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
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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).
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 minutes per coaching session) for 16 weeks.
Interventions
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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 minutes per coaching session) for 16 weeks.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
14 Years
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Drexel University
OTHER
Responsible Party
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Stephanie Manasse
Assistant Professor
Principal Investigators
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Stephanie Manasse, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Drexel University
Locations
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Drexel University WELL Center
Philadelphia, Pennsylvania, United States
Countries
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Other Identifiers
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2310010117
Identifier Type: -
Identifier Source: org_study_id