Modeling the Epidemiologic Transition Study

NCT ID: NCT02925156

Last Updated: 2025-09-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2506 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-16

Study Completion Date

2024-05-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Loyola University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amy Luke

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amy Luke, PhD

Role: PRINCIPAL_INVESTIGATOR

Loyola University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loyola University Medical Center

Maywood, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 14502096 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15151469 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15543214 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12529186 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15475226 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 7823386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8772712 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 8667571 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10429749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12449285 (View on PubMed)

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.

Reference Type RESULT
PMID: 24758286 (View on PubMed)

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.

Reference Type RESULT
PMID: 28133575 (View on PubMed)

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01DK080763

Identifier Type: NIH

Identifier Source: secondary_id

View Link

200038

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Obesity and Mortality
NCT01889225 COMPLETED
The Netherlands Epidemiology of Obesity Study
NCT03410316 ACTIVE_NOT_RECRUITING