Modeling the Epidemiologic Transition Study

NCT02925156 | Completed Results

• 2 other identifiers: 200038R01DK080763
• Study Type: observational
• Target: 2,506
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Diabetes

Keywords

Activity Energy Expenditure; Doubly Labeled Water; Physical Activity; Obesity; Diabetes; Cardiovascular Disease; Adiponectin; Leptin; Ghrelin

Outcome Measures

Primary Outcomes (1)

• Change in Body Weight

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

  24 months

Study Arms (10)

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.

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.

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.

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.

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.

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.

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Identify as African American or Black
• Age 18-50

You may not qualify if:

• Pregnancy, nursing, or planning to become pregnant
• Movement disorders or other disability that limits mobility

Sponsors & Collaborators

• Loyola University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (12)

• Zimmet P. The burden of type 2 diabetes: are we doing enough? Diabetes Metab. 2003 Sep;29(4 Pt 2):6S9-18. doi: 10.1016/s1262-3636(03)72783-9.

  PMID: 14502096 BACKGROUND

• Scaglione R, Argano C, Di Chiara T, Licata G. Obesity and cardiovascular risk: the new public health problem of worldwide proportions. Expert Rev Cardiovasc Ther. 2004 Mar;2(2):203-12. doi: 10.1586/14779072.2.2.203.

  PMID: 15151469 BACKGROUND

• Popkin BM, Gordon-Larsen P. The nutrition transition: worldwide obesity dynamics and their determinants. Int J Obes Relat Metab Disord. 2004 Nov;28 Suppl 3:S2-9. doi: 10.1038/sj.ijo.0802804.

  PMID: 15543214 BACKGROUND

• Kohn M, Booth M. The worldwide epidemic of obesity in adolescents. Adolesc Med. 2003 Feb;14(1):1-9.

  PMID: 12529186 BACKGROUND

• James PT. Obesity: the worldwide epidemic. Clin Dermatol. 2004 Jul-Aug;22(4):276-80. doi: 10.1016/j.clindermatol.2004.01.010.

  PMID: 15475226 BACKGROUND

• Pate RR, Pratt M, Blair SN, Haskell WL, Macera CA, Bouchard C, Buchner D, Ettinger W, Heath GW, King AC, et al. Physical activity and public health. A recommendation from the Centers for Disease Control and Prevention and the American College of Sports Medicine. JAMA. 1995 Feb 1;273(5):402-7. doi: 10.1001/jama.273.5.402.

  PMID: 7823386 BACKGROUND

• Fletcher GF, Balady G, Blair SN, Blumenthal J, Caspersen C, Chaitman B, Epstein S, Sivarajan Froelicher ES, Froelicher VF, Pina IL, Pollock ML. Statement on exercise: benefits and recommendations for physical activity programs for all Americans. A statement for health professionals by the Committee on Exercise and Cardiac Rehabilitation of the Council on Clinical Cardiology, American Heart Association. Circulation. 1996 Aug 15;94(4):857-62. doi: 10.1161/01.cir.94.4.857. No abstract available.

  PMID: 8772712 BACKGROUND

• Physical activity and cardiovascular health. NIH Consensus Development Panel on Physical Activity and Cardiovascular Health. JAMA. 1996 Jul 17;276(3):241-6.

  PMID: 8667571 BACKGROUND

• Morrow JR Jr, Jackson AW, Bazzarre TL, Milne D, Blair SN. A one-year follow-up to physical activity and health. A report of the Surgeon General. Am J Prev Med. 1999 Jul;17(1):24-30. doi: 10.1016/s0749-3797(99)00030-6.

  PMID: 10429749 BACKGROUND

• Trumbo P, Schlicker S, Yates AA, Poos M; Food and Nutrition Board of the Institute of Medicine, The National Academies. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002 Nov;102(11):1621-30. doi: 10.1016/s0002-8223(02)90346-9. No abstract available.

  PMID: 12449285 BACKGROUND

• Luke A, Bovet P, Plange-Rhule J, Forrester TE, Lambert EV, Schoeller DA, Dugas LR, Durazo-Arvizu RA, Shoham DA, Cao G, Brage S, Ekelund U, Cooper RS. A mixed ecologic-cohort comparison of physical activity & weight among young adults from five populations of African origin. BMC Public Health. 2014 Apr 24;14:397. doi: 10.1186/1471-2458-14-397.

  PMID: 24758286 RESULT

• Dugas LR, Kliethermes S, Plange-Rhule J, Tong L, Bovet P, Forrester TE, Lambert EV, Schoeller DA, Durazo-Arvizu RA, Shoham DA, Cao G, Brage S, Ekelund U, Cooper RS, Luke A. Accelerometer-measured physical activity is not associated with two-year weight change in African-origin adults from five diverse populations. PeerJ. 2017 Jan 19;5:e2902. doi: 10.7717/peerj.2902. eCollection 2017.

  PMID: 28133575 RESULT

MeSH Terms

Conditions

Obesity; Diabetes Mellitus; Motor Activity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Behavior

Results Point of Contact

• Title: Amy Luke, Ph.D.
• Organization: Loyola University Chicago

aluke@luc.edu

(464) 220-9243

Study Officials

• Amy Luke, PhD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2016
• First Posted: October 5, 2016
• Study Start: July 16, 2008
• Primary Completion: May 20, 2024
• Study Completion: May 20, 2024
• Last Updated: September 17, 2025
• Results First Posted: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)