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Aerobic Exercise for Adolescent Obesity (AAAA2 INT Trial)

N/A
Recruiting
Research Sponsored by Children's Mercy Hospital Kansas City
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Tanner Stage III-V
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

AAAA2 INT Trial Summary

This trial will help researchers understand how different levels of physical activity affect metabolism and appetite in adolescents.

Who is the study for?
This trial is for overweight or obese, non-smoking adolescents who have been weight-stable in the past 3 months and are not currently pregnant nor have a history of eating disorders. They should not be on medications affecting exercise performance or metabolism, and must not be partaking in other research studies.Check my eligibility
What is being tested?
The study aims to understand how regular moderate-to-vigorous physical activity (MVPA) affects metabolic function and appetite control in sedentary overweight/obese teens. Participants will be randomly placed into either a control group or an exercise group that receives structured aerobic workouts for three months.See study design
What are the potential side effects?
While this study does not involve medication, potential side effects from increased physical activity may include muscle soreness, fatigue, and risk of injury. The newsletter intervention is unlikely to cause direct side effects.

AAAA2 INT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My body shows moderate to full physical development.

AAAA2 INT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Appetite- adjusted
Appetite- objective
Appetite- subjective

AAAA2 INT Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Structured exerciseExperimental Treatment1 Intervention
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.
Group II: Newsletter controlActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic exercise
2000
Completed Phase 2
~1130

Find a Location

Who is running the clinical trial?

Children's Mercy Hospital Kansas CityLead Sponsor
245 Previous Clinical Trials
935,755 Total Patients Enrolled
9 Trials studying Obesity
10,574 Patients Enrolled for Obesity

Media Library

Aerobic exercise Clinical Trial Eligibility Overview. Trial Name: NCT05443347 — N/A
Obesity Research Study Groups: Structured exercise, Newsletter control
Obesity Clinical Trial 2023: Aerobic exercise Highlights & Side Effects. Trial Name: NCT05443347 — N/A
Aerobic exercise 2023 Treatment Timeline for Medical Study. Trial Name: NCT05443347 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum enrollment quota for this research endeavor?

"Affirmative. Evidence hosted on clinicaltrials.gov suggests that this medical trial is actively enrolling volunteers; the study was first posted in late July and last updated at the end of August, with a goal to recruit 44 patients from one site."

Answered by AI

Does this medical trial accept volunteers?

"This research is selecting a cohort of 44 patients between the ages 14 and 17, who have obesity. Other requirements for participation include abstinence from smoking, Tanner Stage III-V development, stabilized weight (within 10% of their baseline) within the last three months, as well as not being presently engaged in any other investigations."

Answered by AI

Are there any unfilled roles in this experiment for volunteers?

"Clinicaltrials.gov attests to this clinical trial's ongoing recruitment process, which began on July 28th 2022 and underwent its latest amendment on August 25th of the same year."

Answered by AI

Is the subject population of this experiment limited to those younger than 75 years?

"For this research initiative, individuals who are between 14 and 17 years of age may be considered for enrolment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Activity, Adiposity, and Appetite in Adolescents 2 Intervention
Robin Shook 2022. "Activity, Adiposity, and Appetite in Adolescents 2 Intervention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05443347.
~13 spots leftby Dec 2024
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