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Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population (InSight)

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ClinicalTrials.gov Identifier: NCT00945633
Recruitment Status : Active, not recruiting
First Posted : July 24, 2009
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Peter T. Katzmarzyk, Pennington Biomedical Research Center

July 22, 2009
July 24, 2009
February 26, 2018
June 2008
August 2023   (Final data collection date for primary outcome measure)
Changes in body weight [ Time Frame: Annually over 2 years ]
Changes in body weight (kg) from baseline
Identify dietary, physiological, genetic and behavioral determinants of unhealthy weight gain over a ten-year period in healthy, young, ethnically-mixed men and women with no, one, or two obese parents. [ Time Frame: Annually over 10 years ]
Complete list of historical versions of study NCT00945633 on ClinicalTrials.gov Archive Site
Changes in fat mass [ Time Frame: Annually over 2 years ]
Changes in fat mass (kg) from baseline
  • Identify relationships between genetic measures of taste perception and the determinants of unhealthy weight gain in the said population. [ Time Frame: Baseline, Year 5, and Year 10 ]
  • Identify relationships among the determinants of unhealthy weight gain that contribute to an individual's susceptibility to obesity. [ Time Frame: Ongoing over 10 years ]
Not Provided
Not Provided
 
Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population
Dietary, Physiological, Genetic, and Behavioral Predictors of Health in a Young, Ethnically-Mixed Population

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.

This is a prospective, longitudinal, clinical study using an epidemiological approach. The sample consists of 90 free-living participants aged 20-35 years. The participants will undergo a series of assessments in the domains of diet, physiological factors, and behavioral factors at baseline and every 12 months for 2 years.

OBJECTIVES

  1. Identify dietary, physiological, genetic and behavioral determinants of unhealthy weight gain in healthy, young, ethnically-mixed men and women.
  2. Identify relationships between genetic measures of taste perception and the determinants of unhealthy weight gain in the said population.
  3. Identify relationships among the determinants of unhealthy weight gain that contribute to an individual's susceptibility to obesity.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Archival repository
Non-Probability Sample
The sample includes 90 free-living participants aged 20-35 years.
Obesity
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
90
1200
August 2023
August 2023   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Inclusion criteria will be healthy men and women between the ages of 20-35, with BMI < 27.5 kg/m2, and fasting blood glucose < 126 mg/dl.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
20 Years to 35 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00945633
PBRC 27036
No
Not Provided
Plan to Share IPD: No
Peter T. Katzmarzyk, Pennington Biomedical Research Center
Pennington Biomedical Research Center
Not Provided
Principal Investigator: Peter Katzmarzyk, Ph.D. Pennington Biomedical Research Center
Pennington Biomedical Research Center
February 2018