N/A
Completed N=342
Translational Investigation of Growth and Everyday Routines in Kids
Source: ClinicalTrials.gov NCT02784509 ↗Enrolled (actual)
342
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcomePrimary: Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity — 21.4; 7.6; 1.0 Minutes measured from accelerometers
Summary
The purpose of this study is to determine the effect of severe obesity on physical activity, sedentary behavior and cardiometabolic risk factors during childhood and adolescence and whether these associations are modified by race. Additionally, the study will investigate the contributions of (total, regional, and depot-specific) fat accumulation on changes in physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and adolescence.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity |
21.4; 7.6; 1.0 | — |
| PRIMARY Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose Tissue |
.6 | — |
| PRIMARY Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Adiposity |
70.7 | — |
| PRIMARY Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%) |
34.2 | — |
| PRIMARY Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist Circumfrence |
78.4 | — |
| SECONDARY Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years. |
33.35; 26.21 | — |
| SECONDARY Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years. |
7.03; 6.17 | — |
| SECONDARY Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. |
0.5; 5.0; 5.5; 36.7; 20.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 10-16 years
- Body weight < 500 lbs.
- Ability to understand instructions and complete all study procedures
Exclusion Criteria
- Pregnant
- On a restrictive diet due to illness
- Significant physical or mental disabilities that impede walking, wearing accelerometer or GPS, or responding to EMA.
Data sourced from ClinicalTrials.gov (NCT02784509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.