Activity, Adiposity, and Appetite in Adolescents 2 Intervention

NCT05443347 | Completed Results DMC

• 2 other identifiers: STUDY00002194K01DK119545
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Appetite; Metabolism; Insulin Sensitivity; Obesity; Energy Balance

Outcome Measures

Primary Outcomes (3)

• Appetite- Subjective

  The investigators will measure subjective appetite ratings using visual analog scales related to hunger following a fixed-calorie meal: Hunger, Area Under the Curve (AUC) Hunger and palatability were assessed using self-rated visual analogue scales (Rogers, P. J., \& Blundell, J. E. (1993). Intense sweeteners and appetite. The American Journal of Clinical Nutrition, 58(1), 120-122.) Scale is 0-100, with 0 equaling 'I am not hungry at all' and 100 equaling 'I have never been more hungry'. Area under the curve (AUC) was calculated for appetite variables by calculating the area of the response as you would a trapezoid.

  3 months

• Appetite- Objective

  he investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.

  3 months

• Appetite- Adjusted

  The investigators will measure objective and subjective appetite responses as described above adjusted by insulin sensitivity (glucose infusion rate, mg/kg/min) as assessed in the euglycemic hyperinsulinemic clamp technique.

  3 months

Study Arms (2)

Structured exercise

EXPERIMENTAL

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.

Behavioral: Aerobic exercise

Newsletter control

ACTIVE COMPARATOR

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.

Behavioral: Newsletter

Interventions

Aerobic exercise BEHAVIORAL

Supervised aerobic exercise

Structured exercise

Newsletter BEHAVIORAL

Biweekly newsletter

Newsletter control

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Tanner Stage III-V, as determined via self-assessment
• Non-smoking
• Not currently involved in any other research study
• No meds that may alter metabolism
• Sedentary (\<60 min/day exercise)
• Willing to participate in an exercise program

You may not qualify if:

• BMI \<5th percentile or \>99th percentile for age and sex
• Weight not stable
• Restrained eater (\>13 on the restraint section of the three-factor eating questionnaire; Current/past diagnosis of an eating disorder.
• Self-reported medical conditions (including, but not limited to, diabetes, Crohn's disease, etc.) that may affect adherence to the protocol, exercising safely, or alter metabolism
• Taking medications know to affect metabolism (e.g. thyroid medication, β-blockers, or stimulants).
• Gave birth in the past 12 months or \<6 months post-lactation.
• Active (\>60 min/day exercise)
• Not willing to participate in an exercise program

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Obesity; Insulin Resistance

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Robin Shook
• Organization: Children's Mercy

rpshook@cmh.edu

816-234-9251

Study Officials

• Robin P Shook, PhD

  Children's Mercy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 5, 2022
• Study Start: September 14, 2022
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: February 12, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)