Translational Investigation of Growth and Everyday Routines in Kids

Childhood Obesity Clinical Trial

— TIGER Kids  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02784509
• Other study ID #: PBRC 2016-028
• Secondary ID: 3092-51000-04A
• Status: Completed
• Start date: June 2016
• Est. completion date: September 2020

Study information

• Verified date: June 2023
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 16 Years

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.

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective 1 Primary Outcome: Change in minutes of sedentary behavior	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
Primary	Objective 2 Primary Outcome: Relationship between total fat accumulation and change in sedentary behavior.	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
Primary	Objective 3 Primary Outcome: Relationship between BMIz and the environmental (or socio-emotional) factors.	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	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.	Year 0 and Year 2
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.	Year 0 and Year 2
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.	Year 0 and Year 2