Trial Outcomes & Findings for Activity, Adiposity, and Appetite in Adolescents 2 Intervention (NCT NCT05443347)
NCT ID: NCT05443347
Last Updated: 2026-02-12
Results Overview
he investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
31 participants
Primary outcome timeframe
3 months
Results posted on
2026-02-12
Participant Flow
Participant milestones
| Measure |
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.
Aerobic exercise: Supervised aerobic exercise
|
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.
Newsletter: Biweekly newsletter
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
12
|
|
Overall Study
COMPLETED
|
14
|
11
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Activity, Adiposity, and Appetite in Adolescents 2 Intervention
Baseline characteristics by cohort
| Measure |
Structured Exercise
n=19 Participants
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.
Aerobic exercise: Supervised aerobic exercise
|
Newsletter Control
n=12 Participants
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.
Newsletter: Biweekly newsletter
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=41 Participants
|
12 Participants
n=1581 Participants
|
31 Participants
n=4626 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Age, Continuous
|
16.3 years
STANDARD_DEVIATION 1.1 • n=41 Participants
|
15.6 years
STANDARD_DEVIATION 0.9 • n=1581 Participants
|
15.9 years
STANDARD_DEVIATION 1.1 • n=4626 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
22 Participants
n=4626 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
9 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=41 Participants
|
4 Participants
n=1581 Participants
|
7 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=41 Participants
|
8 Participants
n=1581 Participants
|
23 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
1 Participants
n=4626 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=41 Participants
|
0 Participants
n=1581 Participants
|
0 Participants
n=4626 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=41 Participants
|
12 participants
n=1581 Participants
|
31 participants
n=4626 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Structured Exercise
n=14 Participants
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.
Aerobic exercise: Supervised aerobic exercise
|
Newsletter Control
n=11 Participants
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.
Newsletter: Biweekly newsletter
|
|---|---|---|
|
Appetite- Subjective
|
6282 score*minute
Standard Error 1075
|
8738 score*minute
Standard Error 1171
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: 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.
he investigators will measure objective appetite responses using plasma ghrelin following a fixed-calorie meal.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Structured Exercise
n=14 Participants
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.
Aerobic exercise: Supervised aerobic exercise
|
Newsletter Control
n=11 Participants
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.
Newsletter: Biweekly newsletter
|
|---|---|---|
|
Appetite- Adjusted
|
7482 score on a scale*min
Standard Error 1094
|
8269 score on a scale*min
Standard Error 1094
|
Adverse Events
Structured Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Newsletter Control
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Structured Exercise
n=19 participants at risk
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.
Aerobic exercise: Supervised aerobic exercise
|
Newsletter Control
n=12 participants at risk
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.
Newsletter: Biweekly newsletter
|
|---|---|---|
|
General disorders
Sore arm following IV
|
0.00%
0/19 • Average of 117 days
|
8.3%
1/12 • Number of events 1 • Average of 117 days
|
|
General disorders
Skin reaction to activity monitor
|
0.00%
0/19 • Average of 117 days
|
8.3%
1/12 • Number of events 1 • Average of 117 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place