Diabetes, Obesity
Conditions
Keywords
Activity Energy Expenditure, Doubly Labeled Water, Physical Activity, Obesity, Diabetes, Cardiovascular Disease, Adiponectin, Leptin, Ghrelin
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Identify as African American or Black * Age 18-50
Exclusion criteria
* Pregnancy, nursing, or planning to become pregnant * Movement disorders or other disability that limits mobility
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 24 months | The change in body weight (measured in kilograms) will be measured for participants 24 months after baseline. |
Countries
United States
Participant flow
Recruitment details
Recruitment began on July 16, 2008 and ended on February 22, 2019
Participants by arm
| Arm | Count |
|---|---|
| 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. | 207 |
| 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. | 236 |
| 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. | 249 |
| 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. | 230 |
| 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. | 245 |
| 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. | 293 |
| 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. | 268 |
| 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. | 251 |
| 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. | 270 |
| 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. | 257 |
| Total | 2,506 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 27 | 53 | 51 | 59 | 89 | 107 | 34 | 36 | 73 | 34 |
Baseline characteristics
| Characteristic | South African Men | Jamaican Men | Seychelles Men | United States Men | Ghanaian Women | South African Women | Ghanaian Men | Jamaican Women | Seychelles Women | United States Women | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 33.7 years STANDARD_DEVIATION 5.6 | 34.0 years STANDARD_DEVIATION 5.9 | 36.5 years STANDARD_DEVIATION 5.1 | 35.6 years STANDARD_DEVIATION 6.2 | 34.0 years STANDARD_DEVIATION 6.6 | 33.1 years STANDARD_DEVIATION 6 | 34.6 years STANDARD_DEVIATION 6.7 | 34.7 years STANDARD_DEVIATION 6.2 | 35.8 years STANDARD_DEVIATION 6 | 35.0 years STANDARD_DEVIATION 6.3 | 34.7 years STANDARD_DEVIATION 6.2 |
| Body Mass Index | 22.4 kg/m^2 STANDARD_DEVIATION 4.3 | 23.6 kg/m^2 STANDARD_DEVIATION 4.5 | 26.5 kg/m^2 STANDARD_DEVIATION 4.9 | 29.7 kg/m^2 STANDARD_DEVIATION 7.5 | 25.5 kg/m^2 STANDARD_DEVIATION 5.2 | 31.9 kg/m^2 STANDARD_DEVIATION 8.2 | 22.2 kg/m^2 STANDARD_DEVIATION 2.7 | 29.5 kg/m^2 STANDARD_DEVIATION 6.7 | 27.6 kg/m^2 STANDARD_DEVIATION 6.2 | 34.1 kg/m^2 STANDARD_DEVIATION 8.8 | 27.4 kg/m^2 STANDARD_DEVIATION 7.3 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | — | — | — | 0 Participants |
| Region of Enrollment Ghana | 0 participants | 0 participants | 0 participants | 0 participants | 293 participants | 0 participants | 207 participants | 0 participants | 0 participants | 0 participants | 500 participants |
| Region of Enrollment Jamaica | 0 participants | 249 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 251 participants | 0 participants | 0 participants | 500 participants |
| Region of Enrollment Seychelles | 0 participants | 0 participants | 230 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 270 participants | 0 participants | 500 participants |
| Region of Enrollment South Africa | 236 participants | 0 participants | 0 participants | 0 participants | 0 participants | 268 participants | 0 participants | 0 participants | 0 participants | 0 participants | 504 participants |
| Region of Enrollment United States | 0 participants | 0 participants | 0 participants | 245 participants | 0 participants | 0 participants | 0 participants | 0 participants | 0 participants | 257 participants | 502 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 293 Participants | 268 Participants | 0 Participants | 251 Participants | 270 Participants | 257 Participants | 1339 Participants |
| Sex: Female, Male Male | 236 Participants | 249 Participants | 230 Participants | 245 Participants | 0 Participants | 0 Participants | 207 Participants | 0 Participants | 0 Participants | 0 Participants | 1167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 207 | 0 / 236 | 0 / 249 | 0 / 230 | 0 / 245 | 0 / 293 | 0 / 268 | 0 / 251 | 0 / 270 | 0 / 257 |
| other Total, other adverse events | 0 / 207 | 0 / 236 | 0 / 249 | 0 / 230 | 0 / 245 | 0 / 293 | 0 / 268 | 0 / 251 | 0 / 270 | 0 / 257 |
| serious Total, serious adverse events | 0 / 207 | 0 / 236 | 0 / 249 | 0 / 230 | 0 / 245 | 0 / 293 | 0 / 268 | 0 / 251 | 0 / 270 | 0 / 257 |
Outcome results
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
Population: The analysis population comprises participants who have a baseline and follow-up body weight recorded
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ghanaian Men | Change in Body Weight | 0.69 kilograms (kg) | Standard Deviation 3.15 |
| South African Men | Change in Body Weight | 0.76 kilograms (kg) | Standard Deviation 4.67 |
| Jamaican Men | Change in Body Weight | 0.20 kilograms (kg) | Standard Deviation 3.9 |
| Seychelles Men | Change in Body Weight | 0.81 kilograms (kg) | Standard Deviation 5.22 |
| United States Men | Change in Body Weight | 0.11 kilograms (kg) | Standard Deviation 5.99 |
| Ghanaian Women | Change in Body Weight | 1.94 kilograms (kg) | Standard Deviation 4.1 |
| South African Women | Change in Body Weight | 2.15 kilograms (kg) | Standard Deviation 6.82 |
| Jamaican Women | Change in Body Weight | -0.11 kilograms (kg) | Standard Deviation 3.72 |
| Seychelles Women | Change in Body Weight | 2.33 kilograms (kg) | Standard Deviation 4.27 |
| United States Women | Change in Body Weight | 0.08 kilograms (kg) | Standard Deviation 6.6 |