Trial Outcomes & Findings for Modeling the Epidemiologic Transition Study (NCT NCT02925156)

NCT ID: NCT02925156

Last Updated: 2025-09-17

Results Overview

The change in body weight (measured in kilograms) will be measured for participants 24 months after baseline.

Recruitment status

COMPLETED

Target enrollment

2506 participants

Primary outcome timeframe

24 months

Results posted on

2025-09-17

Participant Flow

Recruitment began on July 16, 2008 and ended on February 22, 2019

Participant milestones

Participant milestones
Measure
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Overall Study
STARTED
207
236
249
230
245
293
268
251
270
257
Overall Study
COMPLETED
180
183
198
171
156
186
234
215
197
223
Overall Study
NOT COMPLETED
27
53
51
59
89
107
34
36
73
34

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Overall Study
Lost to Follow-up
27
53
51
59
89
107
34
36
73
34

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ghanaian Men
n=207 Participants
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.
South African Men
n=236 Participants
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.
Jamaican Men
n=249 Participants
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.
Seychelles Men
n=230 Participants
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.
United States Men
n=245 Participants
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.
Ghanaian Women
n=293 Participants
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.
South African Women
n=268 Participants
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.
Jamaican Women
n=251 Participants
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.
Seychelles Women
n=270 Participants
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.
United States Women
n=257 Participants
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.
Total
n=2506 Participants
Total of all reporting groups
Age, Continuous
34.6 years
STANDARD_DEVIATION 6.7 • n=207 Participants
33.7 years
STANDARD_DEVIATION 5.6 • n=236 Participants
34.0 years
STANDARD_DEVIATION 5.9 • n=249 Participants
36.5 years
STANDARD_DEVIATION 5.1 • n=230 Participants
35.6 years
STANDARD_DEVIATION 6.2 • n=245 Participants
34.0 years
STANDARD_DEVIATION 6.6 • n=293 Participants
33.1 years
STANDARD_DEVIATION 6.0 • n=268 Participants
34.7 years
STANDARD_DEVIATION 6.2 • n=251 Participants
35.8 years
STANDARD_DEVIATION 6.0 • n=270 Participants
35.0 years
STANDARD_DEVIATION 6.3 • n=257 Participants
34.7 years
STANDARD_DEVIATION 6.2 • n=2506 Participants
Sex: Female, Male
Female
0 Participants
n=207 Participants
0 Participants
n=236 Participants
0 Participants
n=249 Participants
0 Participants
n=230 Participants
0 Participants
n=245 Participants
293 Participants
n=293 Participants
268 Participants
n=268 Participants
251 Participants
n=251 Participants
270 Participants
n=270 Participants
257 Participants
n=257 Participants
1339 Participants
n=2506 Participants
Sex: Female, Male
Male
207 Participants
n=207 Participants
236 Participants
n=236 Participants
249 Participants
n=249 Participants
230 Participants
n=230 Participants
245 Participants
n=245 Participants
0 Participants
n=293 Participants
0 Participants
n=268 Participants
0 Participants
n=251 Participants
0 Participants
n=270 Participants
0 Participants
n=257 Participants
1167 Participants
n=2506 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United States
0 participants
n=207 Participants
0 participants
n=236 Participants
0 participants
n=249 Participants
0 participants
n=230 Participants
245 participants
n=245 Participants
0 participants
n=293 Participants
0 participants
n=268 Participants
0 participants
n=251 Participants
0 participants
n=270 Participants
257 participants
n=257 Participants
502 participants
n=2506 Participants
Region of Enrollment
Ghana
207 participants
n=207 Participants
0 participants
n=236 Participants
0 participants
n=249 Participants
0 participants
n=230 Participants
0 participants
n=245 Participants
293 participants
n=293 Participants
0 participants
n=268 Participants
0 participants
n=251 Participants
0 participants
n=270 Participants
0 participants
n=257 Participants
500 participants
n=2506 Participants
Region of Enrollment
South Africa
0 participants
n=207 Participants
236 participants
n=236 Participants
0 participants
n=249 Participants
0 participants
n=230 Participants
0 participants
n=245 Participants
0 participants
n=293 Participants
268 participants
n=268 Participants
0 participants
n=251 Participants
0 participants
n=270 Participants
0 participants
n=257 Participants
504 participants
n=2506 Participants
Region of Enrollment
Jamaica
0 participants
n=207 Participants
0 participants
n=236 Participants
249 participants
n=249 Participants
0 participants
n=230 Participants
0 participants
n=245 Participants
0 participants
n=293 Participants
0 participants
n=268 Participants
251 participants
n=251 Participants
0 participants
n=270 Participants
0 participants
n=257 Participants
500 participants
n=2506 Participants
Region of Enrollment
Seychelles
0 participants
n=207 Participants
0 participants
n=236 Participants
0 participants
n=249 Participants
230 participants
n=230 Participants
0 participants
n=245 Participants
0 participants
n=293 Participants
0 participants
n=268 Participants
0 participants
n=251 Participants
270 participants
n=270 Participants
0 participants
n=257 Participants
500 participants
n=2506 Participants
Body Mass Index
22.2 kg/m^2
STANDARD_DEVIATION 2.7 • n=207 Participants
22.4 kg/m^2
STANDARD_DEVIATION 4.3 • n=236 Participants
23.6 kg/m^2
STANDARD_DEVIATION 4.5 • n=249 Participants
26.5 kg/m^2
STANDARD_DEVIATION 4.9 • n=230 Participants
29.7 kg/m^2
STANDARD_DEVIATION 7.5 • n=245 Participants
25.5 kg/m^2
STANDARD_DEVIATION 5.2 • n=293 Participants
31.9 kg/m^2
STANDARD_DEVIATION 8.2 • n=268 Participants
29.5 kg/m^2
STANDARD_DEVIATION 6.7 • n=251 Participants
27.6 kg/m^2
STANDARD_DEVIATION 6.2 • n=270 Participants
34.1 kg/m^2
STANDARD_DEVIATION 8.8 • n=257 Participants
27.4 kg/m^2
STANDARD_DEVIATION 7.3 • n=2506 Participants

PRIMARY outcome

Timeframe: 24 months

Population: The analysis population comprises participants who have a baseline and follow-up body weight recorded

The change in body weight (measured in kilograms) will be measured for participants 24 months after baseline.

Outcome measures

Outcome measures
Measure
Ghanaian Men
n=180 Participants
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.
South African Men
n=183 Participants
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.
Jamaican Men
n=198 Participants
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.
Seychelles Men
n=171 Participants
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.
United States Men
n=156 Participants
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.
Ghanaian Women
n=186 Participants
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.
South African Women
n=234 Participants
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.
Jamaican Women
n=215 Participants
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.
Seychelles Women
n=197 Participants
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.
United States Women
n=223 Participants
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
0.69 kilograms (kg)
Standard Deviation 3.15
0.76 kilograms (kg)
Standard Deviation 4.67
0.20 kilograms (kg)
Standard Deviation 3.90
0.81 kilograms (kg)
Standard Deviation 5.22
0.11 kilograms (kg)
Standard Deviation 5.99
1.94 kilograms (kg)
Standard Deviation 4.10
2.15 kilograms (kg)
Standard Deviation 6.82
-0.11 kilograms (kg)
Standard Deviation 3.72
2.33 kilograms (kg)
Standard Deviation 4.27
0.08 kilograms (kg)
Standard Deviation 6.60

Adverse Events

Ghanaian Men

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

South African Men

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Jamaican Men

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Seychelles Men

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

United States Men

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Ghanaian Women

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

South African Women

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Jamaican Women

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Seychelles Women

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

United States Women

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Amy Luke, Ph.D.

Loyola University Chicago

Phone: (464) 220-9243

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place