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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02784509
Recruitment Status : Active, not recruiting
First Posted : May 27, 2016
Last Update Posted : May 21, 2020
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Amanda Staiano, Pennington Biomedical Research Center

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.

Condition or disease
Childhood Obesity

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.

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Study Type : Observational
Estimated Enrollment : 342 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids)
Actual Study Start Date : June 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020



Primary Outcome Measures :
  1. Objective 1 Primary Outcome: Change in minutes of sedentary behavior [ Time Frame: Year 0 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.

  2. Objective 2 Primary Outcome: Relationship between total fat accumulation and change in sedentary behavior. [ Time Frame: Year 0 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.

  3. Objective 3 Primary Outcome: Relationship between BMIz and the environmental (or socio-emotional) factors. [ Time Frame: Year 0 and Year 2 ]
    BMIz will be calculated based on the participant's age, height, and weight using the CDC 2000 growth charts. To identify where physical activity occurs, children will wear the QStarz BT Q1000XT data logger for 7 days concurrent with the ActiGraph GT3X+. In regards to the environmental factors, parents of participants will complete the Neighborhood Impact on Kids (NIK) survey, and participants will complete a neighborhood perceptions survey. In regards to socio-emotional factors, participants will complete the Body Image Assessment for Preadolescents, the Mood and Feelings Questionnaire, the Health-Related Quality of Life, the Personal Experiences Checklist related to stress, and the Food Craving Inventory. Further, participants will record negative and positive affect during a 7-day period by responding to prompts on a mobile phone-based app, using ecological momentary assessment.


Secondary Outcome Measures :
  1. Objective 1 Secondary Analysis: Change in daily moderate to vigorous physical activity (MVPA) minutes between years. [ Time Frame: Year 0 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.

  2. Objective 1 Secondary Analysis: Change in days/week of physical activity between years. [ Time Frame: Year 0 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.

  3. Objective 2 Secondary Analysis: Relationship between fat mass accumulation and change in physical activity. [ Time Frame: Year 0 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.


Biospecimen Retention:   Samples Without DNA
An aliquot of sample will be stored in case further tests are needed and if further consent is obtained from the subject.


Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The study aims to identify and recruit 340 boys and girls aged 10 to 16 years. The sample will be screened on the telephone in attempt to achieve a comparable sex and race distribution. An oversample will be taken for severely obese youth so they comprise approximately 50% of the sample (with the other 50% being distributed among normal weight, overweight, and obese status).
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02784509


Locations
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United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
USDA Beltsville Human Nutrition Research Center
Investigators
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Principal Investigator: Amanda E Staiano, PhD PBRC Assistant Professor
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Responsible Party: Amanda Staiano, PBRC Assistant Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT02784509    
Other Study ID Numbers: PBRC 2016-028
3092-51000-04A ( Other Grant/Funding Number: USDA )
First Posted: May 27, 2016    Key Record Dates
Last Update Posted: May 21, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amanda Staiano, Pennington Biomedical Research Center:
Physical Activity
Sedentary Behavior
Cardiometabolic Risk Factors
Childhood and Adolescence
Additional relevant MeSH terms:
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Pediatric Obesity
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms