NCT00945633

Brief Summary

Dietary intervention and other strategies to prevent unhealthy weight gain and the development of obesity should be based on knowledge of dietary, physiological, genetic and behavioral determinants and their contributing interactions. Identifying these determinants is difficult because physiological susceptibility to specific dietary and behavioral factors implicated in unhealthy weight gain differs between populations and individuals within the populations. The research challenge is identifying specific determinants in a free-living, adult population. Understanding the interaction between diet and the underlying susceptibility factors such as physiologic, genetic and epigenetic, and behavioral factors mandate an integrated approach. This integrated approach should include understanding the interplay of physiological factors (genetics, epigenetics, taste preferences, susceptibility to energy excess, etc.) and behavioral factors (food cravings, restraint, disinhibition, physical activity) as each of these domains is a potential driving force in energy expenditure, food preference, dietary choices, and food intake. Which of these factor(s) is most important? The investigators propose that by examining dietary, physiological, genetic, and behavioral factors in an integrated fashion we will gain insight into the obesity epidemic and identify the most important determinants of weight gain. As a secondary aim, the investigators will identify a single parsimonious collection of factors and develop strategies to mitigate the risks of developing obesity.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
49mo left

Started Jun 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2008Aug 2030

Study Start

First participant enrolled

June 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 24, 2009

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2030

Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

22.2 years

First QC Date

July 22, 2009

Last Update Submit

August 21, 2025

Conditions

Keywords

Obesityunhealthy weight gain

Outcome Measures

Primary Outcomes (1)

  • Changes in body weight

    Changes in body weight (kg) from baseline

    Annually over 2 years

Secondary Outcomes (1)

  • Changes in fat mass

    Annually over 2 years

Eligibility Criteria

Age20 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The sample includes 90 free-living participants aged 20-35 years.

You may not qualify if:

  • History of diabetes, history of obesity (BMI \> 30).
  • History of known inherited medical conditions that might influence future health status.
  • Current or planned medication usage that might influence future health status.
  • Prior serious injuries/surgeries that might influence future health status.
  • Women who are pregnant or breastfeeding (once enrolled, pregnancy will not cause subjects to be terminated from the study).
  • Women who are \< 6 months postpartal, or women who have discontinued breastfeeding \< 3 months prior to screening.
  • History of cancer (including skin cancer) within 5 years.
  • History or organ transplant.
  • Previous diagnosis with HIV, Hepatitis B or C, or tuberculosis.
  • Abuse of alcohol or illegal drugs.
  • Abnormal EKG.
  • Presence of pacemaker, defibrillator, or implanted metal.
  • History of eating disorders and abnormal psychological scores for the screening measures described under Psychological Assessment Measures in the Appendix. This psychological screening will be conducted approximately two weeks prior to outpatient testing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Related Publications (9)

  • Harrington DM, Martin CK, Ravussin E, Katzmarzyk PT. Activity related energy expenditure, appetite and energy intake: potential implications for weight management. Appetite. 2013 Aug;67:1-7. doi: 10.1016/j.appet.2013.03.005. Epub 2013 Mar 22.

  • Tudor-Locke C, Martin CK, Brashear MM, Rood JC, Katzmarzyk PT, Johnson WD. Predicting doubly labeled water energy expenditure from ambulatory activity. Appl Physiol Nutr Metab. 2012 Dec;37(6):1091-100. doi: 10.1139/h2012-097. Epub 2012 Sep 11.

  • Edwards LM, Kemp GJ, Dwyer RM, Walls JT, Fuller H, Smith SR, Earnest CP. Integrating muscle cell biochemistry and whole-body physiology in humans:(31)P-MRS data from the InSight trial. Sci Rep. 2013;3:1182. doi: 10.1038/srep01182. Epub 2013 Jan 31.

  • Staiano AE, Marker AM, Martin CK, Katzmarzyk PT. Physical activity, mental health, and weight gain in a longitudinal observational cohort of nonobese young adults. Obesity (Silver Spring). 2016 Sep;24(9):1969-75. doi: 10.1002/oby.21567. Epub 2016 Jul 28.

  • Raja GK, Sarzynski MA, Katzmarzyk PT, Johnson WD, Tchoukalova Y, Smith SR, Bouchard C. Commonality versus specificity among adiposity traits in normal-weight and moderately overweight adults. Int J Obes (Lond). 2014 May;38(5):719-23. doi: 10.1038/ijo.2013.153. Epub 2013 Aug 16.

  • Staiano AE, Martin CK, Champagne CM, Rood JC, Katzmarzyk PT. Sedentary time, physical activity, and adiposity in a longitudinal cohort of nonobese young adults. Am J Clin Nutr. 2018 Nov 1;108(5):946-952. doi: 10.1093/ajcn/nqy191.

  • Katzmarzyk PT, Most J, Redman LM, Rood J, Ravussin E. Energy expenditure and substrate oxidation in White and African American young adults without obesity. Eur J Clin Nutr. 2018 Jun;72(6):920-922. doi: 10.1038/s41430-018-0202-2. Epub 2018 May 30.

  • Fazzino TL, Dorling JL, Apolzan JW, Martin CK. Meal composition during an ad libitum buffet meal and longitudinal predictions of weight and percent body fat change: The role of hyper-palatable, energy dense, and ultra-processed foods. Appetite. 2021 Dec 1;167:105592. doi: 10.1016/j.appet.2021.105592. Epub 2021 Jul 8.

  • Lam YY, Redman LM, Smith SR, Bray GA, Greenway FL, Johannsen D, Ravussin E. Determinants of sedentary 24-h energy expenditure: equations for energy prescription and adjustment in a respiratory chamber. Am J Clin Nutr. 2014 Apr;99(4):834-42. doi: 10.3945/ajcn.113.079566. Epub 2014 Feb 5.

Biospecimen

Retention: SAMPLES WITH DNA

Archival repository

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Katzmarzyk, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 24, 2009

Study Start

June 1, 2008

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

August 1, 2030

Last Updated

August 22, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations