Translational Investigation of Growth and Everyday Routines in Kids

NCT02784509 | Completed Results

• 2 other identifiers: PBRC 2016-0283092-51000-04A
• Study Type: observational
• Target: 342
• Locations: 1 country
• Sites: 1

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.

Conditions

Childhood Obesity

Keywords

Physical Activity; Sedentary Behavior; Cardiometabolic Risk Factors; Childhood and Adolescence

Outcome Measures

Primary Outcomes (5)

• Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity

  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.

  Baseline and Year 2

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

  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.

  Baseline and Year 2

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

  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.

  Baseline and Year 2

• Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%)

  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.

  Baseline and Year 2

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

  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.

  Baseline and Year 2

Secondary Outcomes (3)

• Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years.

  Baseline and Year 2

• Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years.

  Baseline and Year 2

• Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.

  Baseline and Year 2

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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).

You may qualify if:

• Age 10-16 years
• Body weight \< 500 lbs.
• Ability to understand instructions and complete all study procedures

You may not qualify if:

• Pregnant
• On a restrictive diet due to illness
• Significant physical or mental disabilities that impede walking, wearing accelerometer or GPS, or responding to EMA.

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• USDA Beltsville Human Nutrition Research Center: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (16)

• 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.

  PMID: 33858416 BACKGROUND

• 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.

  PMID: 32479369 BACKGROUND

• 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.

  PMID: 32499526 BACKGROUND

• 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.

  PMID: 31987725 BACKGROUND

• 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.

  PMID: 31614711 BACKGROUND

• 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.

  PMID: 31801259 BACKGROUND

• 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.

  PMID: 35977103 BACKGROUND

• 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.

  PMID: 35544287 BACKGROUND

• 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.

  PMID: 34333320 BACKGROUND

• 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.

  PMID: 37897452 BACKGROUND

• 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.

  PMID: 37675056 BACKGROUND

• 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.

  PMID: 37658323 BACKGROUND

• 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.

  PMID: 36724791 BACKGROUND

• 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.

  PMID: 35055781 BACKGROUND

• 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.

  PMID: 35627467 DERIVED

• 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.

  PMID: 32335525 DERIVED

Related Links

• Temporal Changes in Energy-Balance Behaviors and Home Factors in Adolescents with Normal Weight and Those with Overweight or Obesity
• Associations Between Moderate to Vigorous Physical Activity, Sedentary Behavior, and Depressive Symptomatology in Adolescents: A Prospective Observational Cohort Study
• The Potential for Bias across GPS-Accelerometer Combined Wear Criteria among Adolescents

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.

MeSH Terms

Conditions

Pediatric Obesity; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Limitations and Caveats

A limitation to assessing sedentary behavior, affect, \& context is measuring them in real-time outside of the laboratory setting. Real-time assessment of these may better address complexities of daily life. Another limitation is that the current study does not have access to the CoreScan proprietary algorithm, which impedes algorithm-specific recommendations. Population level differences may provide insight to software developers \& researchers on the systematic differences between techniques.

Results Point of Contact

• Title: Dr. Amanda Staiano
• Organization: LSU's Pennington Biomedical Research Center

amanda.staiano@pbrc.edu

225.763.2500

Study Officials

• Amanda E Staiano, PhD

  PBRC Assistant Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PBRC Assistant Professor

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 27, 2016
• Study Start: June 1, 2016
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: December 24, 2024
• Results First Posted: December 24, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)