An observational study in Obesity and Diabetes, sponsored by Loyola University. Completed at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-17.
Sponsored by Loyola University · Observational
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.
Populations all over the world are experiencing rapid increases in the prevalence of obesity and diabetes. To date, the public health response to the emerging obesity epidemic has been almost totally ineffective. As a first line of response, professional bodies and government organizations have issued prevention guidelines, all of which include recommendations on levels of activity energy expenditure (AEE). However, even if fully implemented, it is not clear that the current recommendations on AEE would impact the trend in age-related weight gain. In fact, there is virtually no direct evidence that can be brought to bear on the question of whether the obesity epidemic has resulted primarily or even partially from society-wide declines in habitual physical activity (PA).
To date, epidemiologic research on AEE has relied on very crude measurement tools-primarily questionnaires. These self-reported data capture only a small fraction of the total variance in activity and are potentially confounded when they focus on leisure-time PA. By contrast, direct measurement with doubly labeled water (DLW) provides a precise, unbiased estimate of all forms of non-resting energy expenditure. DLW has also been used to validate the new generation of accelerometers which are efficient measurement tools for larger studies.
In this study, objective measurement tools will be used to examine the "ecology of AEE". This study will take place in 5 countries spanning the range of the activity-obesity spectrum and will combine both within-population person-level and between-population ecological analyses. First, the study will examine whether an individual's amount or pattern of AEE is related to adiposity in a diverse sample of 2,500. Second, the study will evaluate whether a decline in levels of AEE is an important cause of the rapid increases in obesity that currently take place in many societies. As an exploratory aim we will examine the role of selected adipocytokines and the appetite hormone ghrelin.
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The study is comprises a complex samples population based approach drawn from communities in 5 countries: Ghana, Seychelles, South Africa, Jamaica and the US. Approximately 500 participants are enrolled per site for an unweighted total of 2500 participants.
Exclusion Criteria:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in Body Weight
The change in body weight (measured in kilograms) will be measured for participants 24 months after baseline.
Time frame: 24 months
Recruitment began on July 16, 2008 and ended on February 22, 2019
| Milestone | Ghanaian Men | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Jamaican Women | Seychelles Women | United States Women |
|---|---|---|---|---|---|---|---|---|---|---|
| Started | 207 | 236 | 249 | 230 | 245 | 293 | 268 | 251 | 270 | 257 |
| Completed | 180 | 183 | 198 | 171 | 156 | 186 | 234 | 215 | 197 | 223 |
| Not completed | 27 | 53 | 51 | 59 | 89 | 107 | 34 | 36 | 73 | 34 |
| Withdrew: Lost to follow-up | 27 | 53 | 51 | 59 | 89 | 107 | 34 | 36 | 73 | 34 |
The change in body weight (measured in kilograms) will be measured for participants 24 months after baseline.
| kilograms (kg) | Ghanaian Men | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Jamaican Women | Seychelles Women | United States Women |
|---|---|---|---|---|---|---|---|---|---|---|
| Change in Body Weight | 0.69 ± 3.15 | 0.76 ± 4.67 | 0.20 ± 3.90 | 0.81 ± 5.22 | 0.11 ± 5.99 | 1.94 ± 4.10 | 2.15 ± 6.82 | -0.11 ± 3.72 | 2.33 ± 4.27 | 0.08 ± 6.60 |
Collected over Adverse event data were collected for 2 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ghanaian Men | 0/207 (0%) | 0/207 (0%) | 0/207 (0%) |
| South African Men | 0/236 (0%) | 0/236 (0%) | 0/236 (0%) |
| Jamaican Men | 0/249 (0%) | 0/249 (0%) | 0/249 (0%) |
| Seychelles Men | 0/230 (0%) | 0/230 (0%) | 0/230 (0%) |
| United States Men | 0/245 (0%) | 0/245 (0%) | 0/245 (0%) |
| Ghanaian Women | 0/293 (0%) | 0/293 (0%) | 0/293 (0%) |
| South African Women | 0/268 (0%) | 0/268 (0%) | 0/268 (0%) |
| Jamaican Women | 0/251 (0%) | 0/251 (0%) | 0/251 (0%) |
| Seychelles Women | 0/270 (0%) | 0/270 (0%) | 0/270 (0%) |
| United States Women | 0/257 (0%) | 0/257 (0%) | 0/257 (0%) |
The baseline analysis population comprises all participants who signed an informed consent document
| Age, Continuous(years) | Ghanaian Men | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Jamaican Women | Seychelles Women | United States Women | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 34.6 ± 6.7 | 33.7 ± 5.6 | 34.0 ± 5.9 | 36.5 ± 5.1 | 35.6 ± 6.2 | 34.0 ± 6.6 | 33.1 ± 6.0 | 34.7 ± 6.2 | 35.8 ± 6.0 | 35.0 ± 6.3 | 34.7 ± 6.2 |
| Sex: Female, Male(Participants) | Ghanaian Men | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Jamaican Women | Seychelles Women | United States Women | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 | 0 | 293 | 268 | 251 | 270 | 257 | 1339 |
| Male | 207 | 236 | 249 | 230 | 245 | 0 | 0 | 0 | 0 | 0 | 1167 |
| Race and Ethnicity Not Collected(Participants) | Ghanaian Men | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Jamaican Women | Seychelles Women | United States Women | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Count of participants | — | — | — | — | — | — | — | — | — | — | 0 |
| Region of Enrollment(participants) | Ghanaian Men | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Jamaican Women | Seychelles Women | United States Women | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| United States | 0 | 0 | 0 | 0 | 245 | 0 | 0 | 0 | 0 | 257 | 502 |
| Ghana | 207 | 0 | 0 | 0 | 0 | 293 | 0 | 0 | 0 | 0 | 500 |
| South Africa | 0 | 236 | 0 | 0 | 0 | 0 | 268 | 0 | 0 | 0 | 504 |
| Jamaica | 0 | 0 | 249 | 0 | 0 | 0 | 0 | 251 | 0 | 0 | 500 |
| Seychelles | 0 | 0 | 0 | 230 | 0 | 0 | 0 | 0 | 270 | 0 | 500 |
| Body Mass Index(kg/m^2) | Ghanaian Men | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Jamaican Women | Seychelles Women | United States Women | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | 22.2 ± 2.7 | 22.4 ± 4.3 | 23.6 ± 4.5 | 26.5 ± 4.9 | 29.7 ± 7.5 | 25.5 ± 5.2 | 31.9 ± 8.2 | 29.5 ± 6.7 | 27.6 ± 6.2 | 34.1 ± 8.8 | 27.4 ± 7.3 |
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Loyola University