Skip to content

Activity, Adiposity, and Appetite in Adolescents 2

Activity, Adiposity, and Appetite in Adolescents 2

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04028921
Acronym
AAAA2
Enrollment
46
Registered
2019-07-23
Start date
2022-01-03
Completion date
2024-06-30
Last updated
2025-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Sensitivity, Metabolic Disease, Obesity

Brief summary

Our goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight and physical activity using across-sectional study design.

Detailed description

Childhood obesity is the most serious public health problem of the 21st century, given the prevalence, global reach, and widespread health, economic, and social consequences. While weight gain at the most basic level is due to a chronic energy surplus, there are a host of influences that act on the energy balance system that remain largely unknown. Thus, there is a critical need to identify previously unexamined factors that may influence the energy balance system in order to develop effective interventions for prevention and treatment. Our long-term goal is to quantify the dynamic relationships between various physiological and psychological components of the energy balance system. Our short-term goal is to examine linkages between physical activity, appetite control, and energy metabolism in adolescents. The status quo as it relates to appetite control is that body weight status and related peripheral signals are a key regulator of energy intake. In contrast to body weight playing a primary role in energy regulation, our working hypothesis is that high levels of regular moderate-to-vigorous physical activity (MVPA) result in a metabolic phenotype consisting of enhanced metabolic function and proper regulation of appetite, which prevents the development of obesity. The investigators have reported that adults with low levels of MVPA have dysregulated appetite control, evidenced by higher levels of energy intake and elevated levels of dietary disinhibition. Additionally, the investigators have observed that rats with low fitness possess dysregulated control of appetite and reduced hepatic fat oxidation compared to rats with high fitness. Based on these findings in adults and rodents, in addition to supportive work by others, the investigators hypothesize that low levels of MVPA create a metabolic phenotype, leading to dysregulated appetite control which predisposes individuals to weight gain. To test this hypothesis the investigators will perform a study focused on the links between physical activity and appetite. The investigators will assess metabolic function and appetite control in male and female adolescents stratified by bodyweight (normal vs overweight/obese) and physical activity (sedentary vs. active) using a 2 x 2 cross-sectional study design (N=44). The specific aim of the proposed study is: 1) To examine the association between physical activity and appetite control in adolescents, with metabolic function serving as a mediator. At the completion of the study, it is our expectation that the investigators will have described the independent effects of physical activity and body weight on energy metabolism and appetite in adolescents. This study will have a significant positive impact on the understanding of energy balance in adolescents, and will inform public health interventions that specifically target mechanisms associated with weight gain in youth.

Interventions

OTHERNo intervention

This is a cross-sectional study; no intervention

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years

Inclusion criteria

* Tanner Stage III-V * Non-smoking * Not currently involved in any other research study

Exclusion criteria

* Restrained eater (\>13) on the restraint section of the three-factor eating questionnaire; Current/past diagnosis of an eating disorder * Gave birth in the past 12 months or \<6 months post-lactation. * Self-reported medical conditions (diabetes, Crohn's disease, etc.) that may affect adherence to the protocol or exercising safely or alter metabolism * Medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants)

Design outcomes

Primary

MeasureTime frameDescription
Appetite- SubjectiveBaselineThe 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.
Appetite- ObjectiveBaselineThe investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.
Appetite- AdjustedBaselineThe 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. Hunger score on a scale\*min adjusted for glucose infusion rate (mL/kgFFM/min) and sex

Countries

United States

Participant flow

Participants by arm

ArmCount
Normal Weight, Active
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \>=60 min/day of moderate/vigorous physical activity. No intervention: This is a cross-sectional study; no intervention
13
Normal Weight, Sedentary
Male and female adolescents (age 14-17 years), BMI percentile \>=5th to \<75th for age/sex, \<60 min/day of moderate/vigorous physical activity. No intervention: This is a cross-sectional study; no intervention
11
Overweight/Obese, Active
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \>=60 min/day of moderate/vigorous physical activity. No intervention: This is a cross-sectional study; no intervention
12
Overweight/Obese, Sedentary
Male and female adolescents (age 14-17 years), BMI percentile \>=85th to \<99th for age/sex, \<60 min/day of moderate/vigorous physical activity. No intervention: This is a cross-sectional study; no intervention
10
Total46

Baseline characteristics

CharacteristicNormal Weight, ActiveNormal Weight, SedentaryOverweight/Obese, ActiveOverweight/Obese, SedentaryTotal
Age, Categorical
<=18 years
13 Participants11 Participants12 Participants10 Participants46 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Continuous15.9 years
STANDARD_DEVIATION 0.3
16.0 years
STANDARD_DEVIATION 0.4
16.4 years
STANDARD_DEVIATION 0.4
16.4 years
STANDARD_DEVIATION 0.4
16.0 years
STANDARD_DEVIATION 0.2
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants3 Participants4 Participants0 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
11 Participants8 Participants8 Participants10 Participants37 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants0 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Black or African American
2 Participants3 Participants1 Participants5 Participants11 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
10 Participants8 Participants11 Participants5 Participants34 Participants
Region of Enrollment
United States
13 Participants11 Participants12 Participants10 Participants46 Participants
Sex: Female, Male
Female
7 Participants10 Participants8 Participants6 Participants31 Participants
Sex: Female, Male
Male
6 Participants1 Participants4 Participants4 Participants15 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 110 / 120 / 10
other
Total, other adverse events
2 / 132 / 112 / 121 / 10
serious
Total, serious adverse events
0 / 130 / 110 / 120 / 10

Outcome results

Primary

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. Hunger score on a scale\*min adjusted for glucose infusion rate (mL/kgFFM/min) and sex

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Normal Weight, ActiveAppetite- Adjusted8686 score on a scale*minStandard Deviation 1414
Normal Weight, SedentaryAppetite- Adjusted7885 score on a scale*minStandard Deviation 1442
Overweight/Obese, ActiveAppetite- Adjusted6534 score on a scale*minStandard Deviation 1528
Overweight/Obese, SedentaryAppetite- Adjusted8703 score on a scale*minStandard Deviation 1537
Primary

Appetite- Objective

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

Time frame: Baseline

Population: Plasma ghrelin values were not assessed. Blood samples needed for assessment were not obtained due to lack of staff. Samples will not be collected in the future.

Primary

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.

Time frame: Baseline

ArmMeasureValue (MEAN)Dispersion
Normal Weight, ActiveAppetite- Subjective9239.4 score on a scale*minStandard Deviation 3635.1
Normal Weight, SedentaryAppetite- Subjective7879.6 score on a scale*minStandard Deviation 5343.5
Overweight/Obese, ActiveAppetite- Subjective6130.5 score on a scale*minStandard Deviation 4279.7
Overweight/Obese, SedentaryAppetite- Subjective8970.0 score on a scale*minStandard Deviation 3664.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026