Clinical trial NCT02784509: Translational Investigation of Growth and Everyday Routines in Kids
Official title: Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Obesity
Keywords: Physical Activity
Sedentary Behavior
Cardiometabolic Risk Factors
Childhood and Adolescence
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2016-05-27
Enrollment: 342
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Eligibility 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.

Primary outcomes:
measure: Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity
timeFrame: Baseline and Year 2
measure: Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose Tissue
timeFrame: Baseline and Year 2
measure: Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Adiposity
timeFrame: Baseline and Year 2
measure: Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%)
timeFrame: Baseline and Year 2
measure: Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist Circumfrence
timeFrame: Baseline and Year 2
Secondary outcomes:
measure: Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years.
timeFrame: Baseline and Year 2
measure: Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years.
timeFrame: Baseline and Year 2
measure: Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.
timeFrame: Baseline and Year 2
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: PBRC Assistant Professor
name: Amanda E Staiano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kracht CL, Beyl RA, Maher JP, Katzmarzyk PT, Staiano AE. Adolescents' sedentary time, affect, and contextual factors: An ecological momentary assessment study. Int J Behav Nutr Phys Act. 2021 Apr 15;18(1):53. doi: 10.1186/s12966-021-01121-y.
citation: Kepper MM, Staiano AE, Katzmarzyk PT, Reis RS, Eyler AA, Griffith DM, Kendall ML, ElBanna B, Denstel KD, Broyles ST. Using mixed methods to understand women's parenting practices related to their child's outdoor play and physical activity among families living in diverse neighborhood environments. Health Place. 2020 Mar;62:102292. doi: 10.1016/j.healthplace.2020.102292. Epub 2020 Feb 5.
citation: Kracht CL, Katzmarzyk PT, Staiano AE. Comparison of abdominal visceral adipose tissue measurements in adolescents between magnetic resonance imaging and dual-energy X-ray absorptiometry. Int J Obes (Lond). 2021 Jan;45(1):104-108. doi: 10.1038/s41366-020-0621-8. Epub 2020 Jun 4.
citation: Kracht CL, Champagne CM, Hsia DS, Martin CK, Newton RL Jr, Katzmarzyk PT, Staiano AE. Association Between Meeting Physical Activity, Sleep, and Dietary Guidelines and Cardiometabolic Risk Factors and Adiposity in Adolescents. J Adolesc Health. 2020 Jun;66(6):733-739. doi: 10.1016/j.jadohealth.2019.12.011. Epub 2020 Jan 25.
citation: Kepper MM, Staiano AE, Katzmarzyk PT, Reis RS, Eyler AA, Griffith DM, Kendall ML, ElBanna B, Denstel KD, Broyles ST. Neighborhood Influences on Women's Parenting Practices for Adolescents' Outdoor Play: A Qualitative Study. Int J Environ Res Public Health. 2019 Oct 12;16(20):3853. doi: 10.3390/ijerph16203853.
citation: Kracht CL, Chaput JP, Martin CK, Champagne CM, Katzmarzyk PT, Staiano AE. Associations of Sleep with Food Cravings, Diet, and Obesity in Adolescence. Nutrients. 2019 Nov 30;11(12):2899. doi: 10.3390/nu11122899.
citation: Kracht CL, Katzmarzyk PT, Champagne CM, Broyles ST, Hsia DS, Newton RL Jr, Staiano AE. Association between Sleep, Sedentary Time, Physical Activity, and Adiposity in Adolescents: A Prospective Observational Study. Med Sci Sports Exerc. 2023 Jan 1;55(1):110-118. doi: 10.1249/MSS.0000000000003018. Epub 2022 Aug 12.
citation: Staiano AE, Katzmarzyk PT. Visceral, subcutaneous, and total fat mass accumulation in a prospective cohort of adolescents. Am J Clin Nutr. 2022 Sep 2;116(3):780-785. doi: 10.1093/ajcn/nqac129.
citation: Fowler LA, Kracht CL, Denstel KD, Stewart TM, Staiano AE. Bullying experiences, body esteem, body dissatisfaction, and the moderating role of weight status among adolescents. J Adolesc. 2021 Aug;91:59-70. doi: 10.1016/j.adolescence.2021.07.006. Epub 2021 Jul 29.
citation: Hu K, Button AM, Tate CM, Kracht CL, Champagne CM, Staiano AE. Adolescent Diet Quality, Cardiometabolic Risk, and Adiposity: A Prospective Cohort. J Nutr Educ Behav. 2023 Dec;55(12):851-860. doi: 10.1016/j.jneb.2023.10.003. Epub 2023 Oct 27.
citation: Chen S, Kracht CL, Beyl RA, Staiano AE. Temporal Changes in Energy-Balance Behaviors and Home Factors in Adolescents with Normal Weight and Those with Overweight or Obesity. Int J Phys Act Health. 2023;2(2):5. doi: 10.18122/ijpah.020205.boisestate.
citation: Denstel KD, Beyl RA, Danos DM, Kepper MM, Staiano AE, Theall KT, Tseng TS, Broyles ST. An examination of the relationships between the neighborhood social environment, adiposity, and cardiometabolic disease risk in adolescence: a cross-sectional study. BMC Public Health. 2023 Sep 1;23(1):1692. doi: 10.1186/s12889-023-16580-0.
citation: Kracht CL, Pochana SS, Staiano AE. Associations Between Moderate to Vigorous Physical Activity, Sedentary Behavior, and Depressive Symptomatology in Adolescents: A Prospective Observational Cohort Study. J Phys Act Health. 2023 Feb 1;20(3):250-257. doi: 10.1123/jpah.2022-0345. Print 2023 Mar 1.
citation: Kracht CL, Wilburn JG, Broyles ST, Katzmarzyk PT, Staiano AE. Association of Night-Time Screen-Viewing with Adolescents' Diet, Sleep, Weight Status, and Adiposity. Int J Environ Res Public Health. 2022 Jan 15;19(2):954. doi: 10.3390/ijerph19020954.
citation: Kepper MM, Staiano AE, Broyles ST. The Potential for Bias across GPS-Accelerometer Combined Wear Criteria among Adolescents. Int J Environ Res Public Health. 2022 May 13;19(10):5931. doi: 10.3390/ijerph19105931.
citation: Fearnbach SN, Johannsen NM, Martin CK, Katzmarzyk PT, Beyl RA, Hsia DS, Carmichael OT, Staiano AE. A Pilot Study of Cardiorespiratory Fitness, Adiposity, and Cardiometabolic Health in Youth With Overweight and Obesity. Pediatr Exerc Sci. 2020 Apr 25;32(3):124-131. doi: 10.1123/pes.2019-0192.