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Modeling the Epidemiologic Transition Study

Modeling the Epidemiologic Transition: Energy Expenditure, Obesity and Diabetes

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02925156
Acronym
METS
Enrollment
2506
Registered
2016-10-05
Start date
2008-07-16
Completion date
2024-05-20
Last updated
2025-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Obesity

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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH
Loyola University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Change in Body Weight24 monthsThe 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

ArmCount
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
Total2,506

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009
Overall StudyLost to Follow-up275351598910734367334

Baseline characteristics

CharacteristicSouth African MenJamaican MenSeychelles MenUnited States MenGhanaian WomenSouth African WomenGhanaian MenJamaican WomenSeychelles WomenUnited States WomenTotal
Age, Continuous33.7 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 Index22.4 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 Collected0 Participants
Region of Enrollment
Ghana
0 participants0 participants0 participants0 participants293 participants0 participants207 participants0 participants0 participants0 participants500 participants
Region of Enrollment
Jamaica
0 participants249 participants0 participants0 participants0 participants0 participants0 participants251 participants0 participants0 participants500 participants
Region of Enrollment
Seychelles
0 participants0 participants230 participants0 participants0 participants0 participants0 participants0 participants270 participants0 participants500 participants
Region of Enrollment
South Africa
236 participants0 participants0 participants0 participants0 participants268 participants0 participants0 participants0 participants0 participants504 participants
Region of Enrollment
United States
0 participants0 participants0 participants245 participants0 participants0 participants0 participants0 participants0 participants257 participants502 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants293 Participants268 Participants0 Participants251 Participants270 Participants257 Participants1339 Participants
Sex: Female, Male
Male
236 Participants249 Participants230 Participants245 Participants0 Participants0 Participants207 Participants0 Participants0 Participants0 Participants1167 Participants

Adverse events

Event typeEG000
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 / 2070 / 2360 / 2490 / 2300 / 2450 / 2930 / 2680 / 2510 / 2700 / 257
other
Total, other adverse events
0 / 2070 / 2360 / 2490 / 2300 / 2450 / 2930 / 2680 / 2510 / 2700 / 257
serious
Total, serious adverse events
0 / 2070 / 2360 / 2490 / 2300 / 2450 / 2930 / 2680 / 2510 / 2700 / 257

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Ghanaian MenChange in Body Weight0.69 kilograms (kg)Standard Deviation 3.15
South African MenChange in Body Weight0.76 kilograms (kg)Standard Deviation 4.67
Jamaican MenChange in Body Weight0.20 kilograms (kg)Standard Deviation 3.9
Seychelles MenChange in Body Weight0.81 kilograms (kg)Standard Deviation 5.22
United States MenChange in Body Weight0.11 kilograms (kg)Standard Deviation 5.99
Ghanaian WomenChange in Body Weight1.94 kilograms (kg)Standard Deviation 4.1
South African WomenChange in Body Weight2.15 kilograms (kg)Standard Deviation 6.82
Jamaican WomenChange in Body Weight-0.11 kilograms (kg)Standard Deviation 3.72
Seychelles WomenChange in Body Weight2.33 kilograms (kg)Standard Deviation 4.27
United States WomenChange in Body Weight0.08 kilograms (kg)Standard Deviation 6.6

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026