Childhood Obesity
Conditions
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist Circumfrence | Baseline and Year 2 | 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. |
| Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose Tissue | Baseline and Year 2 | 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. |
| Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Adiposity | Baseline and Year 2 | 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. |
| Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%) | Baseline and Year 2 | 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. |
| Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity | Baseline and Year 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years. | Baseline and Year 2 | 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. |
| Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. | Baseline and Year 2 | 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. |
| Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years. | Baseline and Year 2 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 |
| Total | 256 |
Baseline characteristics
| Characteristic | TIGER 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 type | EG000 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
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIGER Kids Sample | Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity | Sedentary Time | 21.4 Minutes measured from accelerometers | Standard Deviation 6.8 |
| TIGER Kids Sample | Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity | Light Physical Activitiy | 7.6 Minutes measured from accelerometers | Standard Deviation 5.7 |
| TIGER Kids Sample | Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity | Moderate-to-vigorous physical activity | 1.0 Minutes measured from accelerometers | Standard Deviation 2.3 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TIGER Kids Sample | Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Adiposity | 70.7 grams | Standard Deviation 30.2 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TIGER Kids Sample | Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%) | 34.2 percentage of body fat | Standard Deviation 10.4 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TIGER Kids Sample | Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose Tissue | .6 liters | Standard Deviation 0.5 |
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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TIGER Kids Sample | Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist Circumfrence | 78.4 cm | Standard Deviation 17.9 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIGER Kids Sample | Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years. | Year 0 | 33.35 Minutes/day | Standard Deviation 19.4 |
| TIGER Kids Sample | Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years. | Year 2 | 26.21 Minutes/day | Standard Deviation 16.67 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIGER Kids Sample | Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years. | Year 2 | 6.17 Days/week | Standard Deviation 1.56 |
| TIGER Kids Sample | Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years. | Year 0 | 7.03 Days/week | Standard Deviation 1.6 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TIGER Kids Sample | Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. | Visceral adipose tissue | 0.5 Kilograms | Standard Deviation 0.4 |
| TIGER Kids Sample | Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. | Subcutaneous adipose tissue | 5.0 Kilograms | Standard Deviation 4.6 |
| TIGER Kids Sample | Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. | Total abdominal adipose tissue | 5.5 Kilograms | Standard Deviation 5 |
| TIGER Kids Sample | Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. | Lean mass | 36.7 Kilograms | Standard Deviation 10.3 |
| TIGER Kids Sample | Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. | Fat mass | 20.8 Kilograms | Standard Deviation 13.9 |