Trial Outcomes & Findings for Translational Investigation of Growth and Everyday Routines in Kids (NCT NCT02784509)

NCT ID: NCT02784509

Last Updated: 2024-12-24

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 342 participants
• Primary outcome timeframe: Baseline and Year 2
• Results posted on: 2024-12-24

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	342
Overall Study COMPLETED	256
Overall Study NOT COMPLETED	86

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Translational Investigation of Growth and Everyday Routines in Kids

Baseline characteristics by cohort

Measure	TIGER Kids Sample n=256 Participants 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.
Age, Categorical <=18 years	256 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	141 Participants n=5 Participants
Sex: Female, Male Male	115 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	95 Participants n=5 Participants
Race (NIH/OMB) White	147 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and Year 2

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

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.

Outcome measures

Measure	TIGER Kids Sample n=284 Participants 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.
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
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
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

PRIMARY outcome

Timeframe: Baseline and Year 2

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

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.

Outcome measures

Measure

TIGER Kids Sample n=251 Participants 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.

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

.6 liters Standard Deviation .5

PRIMARY outcome

Timeframe: Baseline and Year 2

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

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.

Outcome measures

Measure

TIGER Kids Sample n=251 Participants 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.

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

70.7 grams Standard Deviation 30.2

PRIMARY outcome

Timeframe: Baseline and Year 2

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

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.

Outcome measures

Measure

TIGER Kids Sample n=251 Participants 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.

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

PRIMARY outcome

Timeframe: Baseline and Year 2

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

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.

Outcome measures

Measure

TIGER Kids Sample n=251 Participants 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.

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

78.4 cm Standard Deviation 17.9

SECONDARY outcome

Timeframe: Baseline and Year 2

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

Outcome measures

Measure	TIGER Kids Sample n=323 Participants 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.
Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years. Year 0	33.35 Minutes/day Standard Deviation 19.40
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

SECONDARY outcome

Timeframe: Baseline and Year 2

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

Outcome measures

Measure	TIGER Kids Sample n=323 Participants 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.
Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years. Year 0	7.03 Days/week Standard Deviation 1.60
Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years. Year 2	6.17 Days/week Standard Deviation 1.56

SECONDARY outcome

Timeframe: Baseline and Year 2

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

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.

Outcome measures

Measure	TIGER Kids Sample n=217 Participants 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.
Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. Fat mass	20.8 Kilograms Standard Deviation 13.9
Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. Lean mass	36.7 Kilograms Standard Deviation 10.3
Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. Subcutaneous adipose tissue	5.0 Kilograms Standard Deviation 4.6
Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. Total abdominal adipose tissue	5.5 Kilograms Standard Deviation 5.0
Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity. Visceral adipose tissue	0.5 Kilograms Standard Deviation 0.4

Adverse Events

TIGER Kids Sample

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Amanda Staiano

LSU's Pennington Biomedical Research Center

Phone: 225.763.2500

Email: amanda.staiano@pbrc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place