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Clinical Trials/NCT06745570
NCT06745570
Active, not recruiting
Not Applicable

Improving Sleep As a Method for Enhancing Decision-Making and Reducing Problematic Eating Behaviors in Adolescents with Obesity

Drexel University1 site in 1 country50 target enrollmentApril 18, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adolescent Overweight
Sponsor
Drexel University
Enrollment
50
Locations
1
Primary Endpoint
Percent of 95th percentile BMI
Status
Active, not recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 18, 2024
End Date
January 31, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stephanie Manasse

Assistant Professor

Drexel University

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

Outcomes

Primary Outcomes

Percent of 95th percentile BMI

Time Frame: 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

Time Frame: 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

Time Frame: From enrollment to the end of the study (approximately 4 months)

Body fat percentage will also be derived from the Aria Air scale.

Secondary Outcomes

  • 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))

Study Sites (1)

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