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

June 13, 2023 updated by: Amanda Staiano, Pennington Biomedical Research Center

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

342

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 16 years (Child)

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).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Year 0 and Year 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.
Year 0 and Year 2
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.
Year 0 and Year 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Year 0 and Year 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.
Year 0 and Year 2
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.
Year 0 and Year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pennington Biomedical Research Center

Collaborators

USDA Beltsville Human Nutrition Research Center

Investigators

  • Principal Investigator: Amanda E Staiano, PhD, PBRC Assistant Professor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

September 1, 2020

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimated)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 13, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PBRC 2016-028
  • 3092-51000-04A (Other Grant/Funding Number: USDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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