Activity, Adiposity, and Appetite in Adolescents 2 Intervention

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Children's Mercy Hospital Kansas City
Study ID
NCT05443347
Status
Completed

Conditions

  • Appetite
  • Energy Balance
  • Insulin Sensitivity
  • Metabolism
  • Obesity

Eligibility Criteria

Sex
ALL
Age
14 Years - 17 Years
Healthy Volunteers
Accepted

Interventions

  • Aerobic exercise — BEHAVIORAL
    Supervised aerobic exercise
  • Newsletter — BEHAVIORAL
    Biweekly newsletter

Study Details

The objective of the study is to quantify the relationship between physical activity, metabolic function, and appetite in adolescents. To do this we will test our working hypothesis that high levels of regular moderate-to-vigorous physical activity (MVPA), as opposed to body weight status, results in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite. We will randomly assigning sedentary overweight/obese adolescents (N=44) to either a control or structured-exercise group for three months.

Key Dates

Start date
Sep 14, 2022
Status verified
Feb 2026
Primary completion
Nov 25, 2024
Completion
Nov 25, 2024

Study Design

Enrollment
31 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Structured exercise
    Adolescents randomized to the exercise will participate in a supervised structured exercise program (walking on a treadmill, cycling on a stationary bicycle, etc.) and expend an equivalent of 400 kcals/session (approximately 45-60 min/session) on three days/week. We will follow the protocol of Mentor Dr. Joseph Donnelly, with exercise prescriptions progressing from 150 kcal/session at intervention onset to reach the target exercise energy expenditure (EEEx) (400 kcal/session) at the end of month 3. EEEx will be assessed at baseline and monthly during the intervention to determine the duration of treadmill exercise required to achieve the EEEx goals. All supervised exercise will occur at the CCHLN on a treadmill with heart rate, speed, and grade monitored by an exercise specialist every five minutes.
  • Active Comparator: Newsletter control
    Adolescents randomized to the newsletter control will receive with biweekly newsletters with "parenting tips, sample praise statements, and age-appropriate activities and recipes" identical to what has been used by others (Epstein et al., 2008), including existing group-based interventions with overweight/obese adolescents.

Primary Outcome Measure

Appetite- Subjective [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Mercy Kansas CityKansas CityMissouri64108-

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