Modeling the Epidemiologic Transition Study

Part of paid clinical trials in Maywood, Illinois.

Sponsor
Loyola University
Study ID
NCT02925156
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Accepted

Study Details

This project examines whether individuals' amount of activity energy expenditure (AEE) is related to adiposity and adiposity/diabetes-related hormones in a diverse sample of 2500, and to test the ecological hypothesis that a decline in levels of AEE is an important cause of the increases in obesity that are currently taking place in many societies. One goal is to use doubly labeled water and/or accelerometers to objectively measure activity energy expenditure in community samples from five adult populations across the spectrum of obesity risk. From each site, (i.e., Ghana, South Africa, Seychelles, Jamaica, and the US), 500 black adults will be recruited. Among all participants, AEE will be measured using accelerometers and in a subset of 75 per site, AEE will also be measured by doubly labeled water. The doubly labeled water sample will be used to confirm site-specific concordance with the accelerometer measurements and to estimate population mean levels of AEE. Additionally, body composition, dietary intake, fasting glucose, insulin, adiponectin, leptin and ghrelin will be measured. The relationships between calories expended in activity and body composition, dietary intake, glucose, hormones and adipocytokines, both within and between each population using doubly labeled water and accelerometers will be examined. In this longitudinal study, weight will be measured at 12 and 24-months, and AEE by accelerometer will be assessed at enrollment and again at 2-years of follow-up; associations between change in AEE and change in weight will be estimated. The central purpose of this project is to test whether AEE or change in AEE can be identified as a contributory mechanism to population-wide weight gain and, if so, to quantify its importance. In addition, we seek to understand the interrelationships between the adipocytokines and the hormones ghrelin and insulin as well as AEE in the regulation of body weight across the continuum of body mass indices (BMI) represented by these five populations.

Key Dates

Start date
Jul 16, 2008
Status verified
Sep 2025
Primary completion
May 20, 2024
Completion
May 20, 2024

Study Design

Enrollment
2,506 participants (actual)

Arms

  • Arm: Ghanaian Men
    Men in the Ghana cohort are located at or near the the village of Nkwantakese which is approximately 20 kilometers outside of Kwame Nkrumah University of Science and Technology in Kumasi.
  • Arm: South African Men
    Men in the South Africa cohort are located at or near Khayelitsha, the 3rd largest township in South Africa, which is an adjacent town to the city of Cape Town. The population of Khayelitsha is about 500,000 people.
  • Arm: Seychelles Men
    Men in the Seychelles cohort are located at or near The Republic of Seychelles, which is an archipelago with 81,000 inhabitants located approximately 1,500 km east of Kenya in the Indian Ocean and approximately 2,000 km north of the island of Mauritius.
  • Arm: Jamaican Men
    Men in the Jamaica cohort are located at or near Spanish Town, Jamaica which is an urban area 25 km from the center of Kingston. The population of Spanish Town in 1991 was estimated at 92,000 people.
  • Arm: United States Men
    Men in the United States cohort are located at or near Maywood, IL, which is an African-American working class community adjacent to the western border of Chicago, IL. The population of Maywood in 2010 was estimated at 24,090 people.
  • Arm: Ghanaian Women
    Women in the Ghana cohort are located at or near the the village of Nkwantakese which is approximately 20 kilometers outside of Kwame Nkrumah University of Science and Technology in Kumasi.
  • Arm: South African Women
    Women in the South Africa cohort are located at or near Khayelitsha, the 3rd largest township in South Africa, which is an adjacent town to the city of Cape Town. The population of Khayelitsha is about 500,000 people.
  • Arm: Seychelles Women
    Women in the Seychelles cohort are located at or near The Republic of Seychelles, which is an archipelago with 81,000 inhabitants located approximately 1,500 km east of Kenya in the Indian Ocean and approximately 2,000 km north of the island of Mauritius.
  • Arm: Jamaican Women
    Women in the Jamaica cohort are located at or near Spanish Town, Jamaica which is an urban area 25 km from the center of Kingston. The population of Spanish Town in 1991 was estimated at 92,000 people.
  • Arm: United States Women
    Women in the United States cohort are located at or near Maywood, IL, which is an African-American working class community adjacent to the western border of Chicago, IL. The population of Maywood in 2010 was estimated at 24,090 people.

Primary Outcome Measure

Change in Body Weight [ Time Frame: 24 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Loyola University Medical CenterMaywoodIllinois60153-

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