Skip to content

Translational Investigation of Growth and Everyday Routines in Kids

Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02784509
Acronym
TIGER Kids
Enrollment
342
Registered
2016-05-27
Start date
2016-06-30
Completion date
2020-09-30
Last updated
2024-12-24

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

Conditions

Childhood Obesity

Keywords

Physical Activity, Sedentary Behavior, Cardiometabolic Risk Factors, Childhood and Adolescence

Brief 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.

Detailed description

The proposed study will establish a prospective pediatric cohort to identify intervention targets based on the location, timing, barriers, and facilitators of current physical activity and sedentary behavior in a child's day. The project will be a prospective examination of 340 African American and White girls and boys aged 10 to 16 years, including 50% who are classified as severely obese. State-of-the-art technology will be used including accelerometry to quantify physical activity, magnetic resonance imaging to quantify fat accumulation, and geographic position system and ecological momentary assessment to identify environmental and socio-emotional barriers and facilitators. In further detail, this study will examine the following objectives: Objective 1: 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. Objective 2: Investigate the contribution of (total, regional, and depot-specific) fat accumulation on changes in physical activity, sedentary behavior, and cardiometabolic risk factors during childhood and adolescence. Objective 3: Determine barriers and facilitators of physical activity that are related to obesity, including environmental and socio-emotional factors.

Interventions

None listed

Sponsors

USDA Beltsville Human Nutrition Research Center
CollaboratorFED
Pennington Biomedical Research Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
10 Years to 16 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist CircumfrenceBaseline and Year 2Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose TissueBaseline and Year 2Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - AdiposityBaseline and Year 2Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%)Baseline and Year 2Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.
Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical ActivityBaseline and Year 2Physical activity and sedentary behavior will be measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days (plus an initial familiarization day and the morning of the final day), including 2 weekend days. Participants will also complete a Lifestyle survey to collect information including diet and physical activity habits.

Secondary

MeasureTime frameDescription
Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years.Baseline and Year 2MVPA measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL) as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.
Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.Baseline and Year 2Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Physical Activity will be measured by a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.
Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years.Baseline and Year 2MVPA measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL) as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Countries

United States

Participant flow

Participants by arm

ArmCount
TIGER Kids Sample
342 boys and girls ages 10 to 16 years from every weight category (normal weight, overweight, and obese). Used state-of-the-art technology, including activity trackers and global positioning system (GPS) information, to track physical activity, imaging to measure body fat, and messages sent through a mobile phone app (called ecological momentary assessment) to identify what motivates or prevents kids from being physically active. Participants attended an orientation session at Pennington Biomedical to learn about the study, sign consent and receive their activity tracking tools. These tools were returned at clinic visit approximately 1 week later. Assessments include body measurements, blood pressure, surveys, blood draw, dietary recall and body composition. Participants will repeated the activity monitor tracking and a second clinic visit 2 years later.
256
Total256

Baseline characteristics

CharacteristicTIGER Kids Sample
Age, Categorical
<=18 years
256 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
95 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants
Race (NIH/OMB)
White
147 Participants
Sex: Female, Male
Female
141 Participants
Sex: Female, Male
Male
115 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 342
other
Total, other adverse events
0 / 342
serious
Total, serious adverse events
0 / 342

Outcome results

Primary

Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity

Physical activity and sedentary behavior will be measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL). The participant will be instructed to wear the accelerometer on an elasticized belt, on the left mid-axillary line. The Actigraph is one of the most common accelerometers used for scientific purposes. Participants will be encouraged to wear the accelerometer 24-hours per day for at least 7-days (plus an initial familiarization day and the morning of the final day), including 2 weekend days. Participants will also complete a Lifestyle survey to collect information including diet and physical activity habits.

Time frame: Baseline and Year 2

Population: 284/342 children had complete accelerometry data and were therefore included in analysis.

ArmMeasureGroupValue (MEAN)Dispersion
TIGER Kids SampleObjective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical ActivitySedentary Time21.4 Minutes measured from accelerometersStandard Deviation 6.8
TIGER Kids SampleObjective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical ActivityLight Physical Activitiy7.6 Minutes measured from accelerometersStandard Deviation 5.7
TIGER Kids SampleObjective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical ActivityModerate-to-vigorous physical activity1.0 Minutes measured from accelerometersStandard Deviation 2.3
Primary

Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Adiposity

Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Time frame: Baseline and Year 2

Population: 251 children out of 342 had complete data and were therefore included in analysis.

ArmMeasureValue (MEAN)Dispersion
TIGER Kids SampleObjective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Adiposity70.7 gramsStandard Deviation 30.2
Primary

Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%)

Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Time frame: Baseline and Year 2

Population: 251 children out of 342 had complete data and were therefore included in analysis.

ArmMeasureValue (MEAN)Dispersion
TIGER Kids SampleObjective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%)34.2 percentage of body fatStandard Deviation 10.4
Primary

Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose Tissue

Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Time frame: Baseline and Year 2

Population: 251 children out of 342 had complete data and were therefore included in analysis.

ArmMeasureValue (MEAN)Dispersion
TIGER Kids SampleObjective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose Tissue.6 litersStandard Deviation 0.5
Primary

Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist Circumfrence

Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Sedentary behavior will be measured by a a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Time frame: Baseline and Year 2

Population: 251 children out of 342 had complete data and were therefore included in analysis.

ArmMeasureValue (MEAN)Dispersion
TIGER Kids SampleObjective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist Circumfrence78.4 cmStandard Deviation 17.9
Secondary

Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years.

MVPA measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL) as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Time frame: Baseline and Year 2

Population: 323 participants had accelerometry data for Year 0 and 213 participants had accelerometry data for Year 2

ArmMeasureGroupValue (MEAN)Dispersion
TIGER Kids SampleObjective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years.Year 033.35 Minutes/dayStandard Deviation 19.4
TIGER Kids SampleObjective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years.Year 226.21 Minutes/dayStandard Deviation 16.67
Secondary

Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years.

MVPA measured by a triaxial accelerometer (Actigraph GT3X+, Actigraph of Ft. Walton Beach, FL) as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Time frame: Baseline and Year 2

Population: 323/213 participants had accelerometry data in Year 0/Year 2

ArmMeasureGroupValue (MEAN)Dispersion
TIGER Kids SampleObjective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years.Year 26.17 Days/weekStandard Deviation 1.56
TIGER Kids SampleObjective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years.Year 07.03 Days/weekStandard Deviation 1.6
Secondary

Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.

Body composition will be determined by DXA and MRI. With DXA, total body fat and trunk fat will be measured by whole-body DXA using a GE iDXA scanner (GE Medical Systems, Milwaukee, WI) to quantify total and regional body fat (including trunk fat). MRI - Visceral fat, i.e. visceral adipose tissue, will be measured by water-fat shifting MRI using the General Electric Discovery 750w 3.0 Tesla (GE Medical Systems, Milwaukee, WI). IDEAL-IQ imaging technique will be used to generate water-only, fat-only, in-phase, and out-of-phase echoes in a single acquisition with a 20-second breath-hold. Physical Activity will be measured by a triaxial accelerometer as described in outcome 1. Participants will also complete a Lifestyle survey to collect information including physical activity habits.

Time frame: Baseline and Year 2

Population: 217 children out of 342 hand complete data and were therefore included in the analysis

ArmMeasureGroupValue (MEAN)Dispersion
TIGER Kids SampleObjective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.Visceral adipose tissue0.5 KilogramsStandard Deviation 0.4
TIGER Kids SampleObjective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.Subcutaneous adipose tissue5.0 KilogramsStandard Deviation 4.6
TIGER Kids SampleObjective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.Total abdominal adipose tissue5.5 KilogramsStandard Deviation 5
TIGER Kids SampleObjective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.Lean mass36.7 KilogramsStandard Deviation 10.3
TIGER Kids SampleObjective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.Fat mass20.8 KilogramsStandard Deviation 13.9

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026