Childhood ObesityTIGER KidsNCT02784509
Translational Investigation of Growth and Everyday Routines in Kids
An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- Age 10-16 years
- Body weight < 500 lbs.
- Ability to understand instructions and complete all study procedures
Who cannot join
- Pregnant
- On a restrictive diet due to illness
- Significant physical or mental disabilities that impede walking, wearing accelerometer or GPS, or responding to EMA.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
About this study
Official title: 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.
Read the 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.
- Conditions
- Childhood Obesity
- Keywords
- Physical Activity, Sedentary Behavior, Cardiometabolic Risk Factors, Childhood and Adolescence
- Medical subject headings
- Pediatric Obesity, Motor Activity, Sedentary Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and Year 2
Secondary outcomes (3)
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.
Measured: Baseline and Year 2
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.
Measured: Baseline and Year 2
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.
Measured: Baseline and Year 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pennington Biomedical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, Amanda Staiano, Pennington Biomedical Research Center
- Investigators
- Amanda E Staiano, PhD, Principal investigator, PBRC Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784509
- Sponsor's protocol ID
- PBRC 2016-028
- Other IDs
- 3092-51000-04A
- Acronym
- TIGER Kids
- Status last verified
- Nov 2024
- First submitted
- 18 May 2016
- Last updated
- 24 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 33858416Kepper 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.
PubMed 32479369Kracht 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.
PubMed 32499526Kracht 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.
PubMed 31987725Kepper 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.
PubMed 31614711Kracht 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.
PubMed 31801259Kracht 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.
PubMed 35977103Staiano 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.
PubMed 35544287Fowler 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.
PubMed 34333320Hu 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.
PubMed 37897452Chen 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.
PubMed 37675056Denstel 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.
PubMed 37658323Kracht 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.
PubMed 36724791Kracht 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.
PubMed 35055781Suarez-Reyes M, Button AM, Beyl RA, Katzmarzyk PT, Staiano AE. Family, social, and built environment: examining associations with physical activity and sedentary time in adolescents. Front Sports Act Living. 2026 Feb 19;8:1709140. doi: 10.3389/fspor.2026.1709140. eCollection 2026.
PubMed 41800195
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Investigation of Growth and Everyday Routines in Kids (TIGER Kids)
- ClinicalTrials.gov ID
- NCT02784509
- Acronym / sponsor ID
- TIGER Kids / PBRC 2016-028
- Conditions
- Childhood Obesity
- Keywords
- Physical Activity, Sedentary Behavior, Cardiometabolic Risk Factors, Childhood and Adolescence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- Pennington Biomedical Research CenterUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 27 May 2016 (estimated)
- Results
- Posted 24 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- Age 10-16 years
- Body weight < 500 lbs.
- Ability to understand instructions and complete all study procedures
Key exclusion criteria (3 listed)
- Pregnant
- On a restrictive diet due to illness
- Significant physical or mental disabilities that impede walking, wearing accelerometer or GPS, or responding to EMA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity
Time frame: Baseline 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.
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Visceral Adipose Tissue
Time frame: Baseline 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.
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Adiposity
Time frame: Baseline 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.
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior - Body Fat (%)
Time frame: Baseline 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.
Objective 2 Primary Outcome: Relationship Between Total Fat Accumulation and Change in Sedentary Behavior. - Waist Circumfrence
Time frame: Baseline 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 secondary outcomes
Objective 1 Secondary Analysis: Change in Daily Moderate to Vigorous Physical Activity (MVPA) Minutes Between Years.
Time frame: Baseline and Year 2
Objective 1 Secondary Analysis: Change in Days/Week of Physical Activity Between Years.
Time frame: Baseline and Year 2
Objective 2 Secondary Analysis: Relationship Between Fat Mass Accumulation and Change in Physical Activity.
Time frame: Baseline and Year 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33858416Kracht 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.
- Background: PubMed 32479369Kepper 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.
- Background: PubMed 32499526Kracht 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.
- Background: PubMed 31987725Kracht 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.
- Background: PubMed 31614711Kepper 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.
- Background: PubMed 31801259Kracht 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.
- Background: PubMed 35977103Kracht 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.
- Background: PubMed 35544287Staiano 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.
- Background: PubMed 34333320Fowler 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.
- Background: PubMed 37897452Hu 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.
- Background: PubMed 37675056Chen 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.
- Background: PubMed 37658323Denstel 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.
- Temporal Changes in Energy-Balance Behaviors and Home Factors in Adolescents with Normal Weight and Those with Overweight or ObesityLink provided by the sponsor.
- Associations Between Moderate to Vigorous Physical Activity, Sedentary Behavior, and Depressive Symptomatology in Adolescents: A Prospective Observational Cohort StudyLink provided by the sponsor.
- The Potential for Bias across GPS-Accelerometer Combined Wear Criteria among AdolescentsLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Childhood Obesity
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amanda E Staiano, PhD principal investigator
PBRC Assistant Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective 1 Primary Outcome: Change in Minutes of Sedentary Behavior, Light Physical Activity, and Moderate-to-vigorous Physical Activity (time frame: Baseline and Year 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784509, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.