Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Medical Research Methodology
Published in: BMC Medical Research Methodology 1/2009

Open Access 01-12-2009 | Study protocol

Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control

Authors: Milagros C Rosal, Mary Jo White, Angela Restrepo, Barbara Olendzki, Jeffrey Scavron, Elise Sinagra, Ira S Ockene, Michael Thompson, Stephenie C Lemon, Lucy M Candib, George Reed

Published in: BMC Medical Research Methodology | Issue 1/2009

Login to get access

Abstract

Background

US Latinos have greater prevalence of type 2 diabetes (diabetes), uncontrolled diabetes and diabetes co-morbidities compared to non-Latino Whites. They also have lower literacy levels and are more likely to live in poverty. Interventions are needed to improve diabetes control among low-income Latinos.

Methods and design

This randomized clinical trial tested the efficacy of a culturally- and literacy-tailored diabetes self-management intervention (Latinos en Control) on glycemic control among low-income Latinos with diabetes, compared to usual care (control). Participants were recruited from five community health centers (CHCs) in Massachusetts. The theory-based intervention included an intensive phase of 12 weekly sessions and a follow-up maintenance phase of 8 monthly sessions. Assessments occurred at baseline, and at 4 and 12 months. The primary outcome was glycosylated hemoglobin (HbA1c). Secondary outcomes were self-management behaviors, weight, lipids and blood pressure. Additional outcomes included diabetes knowledge, self-efficacy, depression and quality of life. The study was designed for recruitment of 250 participants (estimated 20% dropout rate) to provide 90% power for detecting a 7% or greater change in HbA1c between the intervention and control groups. This is a difference in change of HbA1c of 0.5 to 0.6%.

Discussion

Low-income Latinos bear a great burden of uncontrolled diabetes and are an understudied population. Theory-based interventions that are tailored to the needs of this high-risk population have potential for improving diabetes self-management and reduce health disparities. This article describes the design and methods of a theory driven intervention aimed at addressing this need.

Trial registration

http://​www.​clinicaltrials.​gov # NCT00848315
Appendix
Available only for authorised users
Literature
1.
2.
3.
Centers for Disease Control and Prevention: National diabetes fact sheet: General information and national estimates on diabetes in the United States, 2007. 2008, Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention
4.
5.
6.
Boyle JP, Honeycutt AA, Narayan KM, Hoerger TJ, Geiss LS, Chen H, Thompson TJ: Projection of diabetes burden through 2050: Impact of changing demography and disease prevalence in the U.S. Diabetes Care. 2001, 24: 1936-1940. 10.2337/diacare.24.11.1936.CrossRefPubMed
7.
Mainous AG, Baker R, Koopman RJ, Saxena S, Diaz VA, Everett CJ, Majeed A: Impact of the population at risk of diabetes on projections of diabetes burden in the United States: An epidemic on the way. Diabetologia. 2006, 50: 934-940. 10.1007/s00125-006-0528-5.CrossRefPubMedPubMedCentral
8.
Lasater LM, Davidson AJ, Steiner JF, Mehler PS: Glycemic control in English- vs Spanish-speaking Hispanic patients with type 2 diabetes mellitus. Arch Intern Med. 2001, 161: 77-82. 10.1001/archinte.161.1.77.CrossRefPubMed
9.
Harris MI: Racial and ethnic differences in health care access and health outcomes for adults with type 2 diabetes. Diabetes Care. 2001, 24: 454-459. 10.2337/diacare.24.3.454.CrossRefPubMed
10.
Brown SA, Becker HA, Garcia AA, Barton SA, Hanis CL: Measuring health beliefs in Spanish-speaking Mexican Americans with type 2 diabetes: adapting an existing instrument. Res Nurs Health. 2002, 25: 145-158. 10.1002/nur.10023.CrossRefPubMed
11.
Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS: Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999, 22: 403-408. 10.2337/diacare.22.3.403.CrossRefPubMed
12.
Brown SA, Garcia AA, Kouzekanani K, Hanis CL: Culturally competent diabetes self-management education for Mexican Americans: The Starr County border health initiative. Diabetes Care. 2002, 25: 259-268. 10.2337/diacare.25.2.259.CrossRefPubMedPubMedCentral
13.
Saydah S, Cowie C, Eberhardt MS, De Rekeneire N, Narayan KM: Race and ethnic differences in glycemic control among adults with diagnosed diabetes in the United States. Ethn Dis. 2007, 17: 529-535.PubMed
14.
Diehl AK, Stern MP: Special health problems of Mexican Americans: Obesity, gallbladder disease, diabetes mellitus and cardiovascular disease. Adv Intern Med. 1989, 34: 79-96.
15.
Haffner SM, Fong D, Stern MP, Pugh JA, Hazuda HP, Patterson JK, Van Heuven WAJ, Klein R: Diabetic retinopathy in Mexican Americans and non-Hispanic whites. Diabetes. 1988, 37: 878-884. 10.2337/diabetes.37.7.878.CrossRefPubMed
16.
The Diabetes Control and Complications Trial Research Group: The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993, 329: 977-986. 10.1056/NEJM199309303291401.CrossRef
17.
U.K. prospective diabetes study 16. Overview of 6 years' therapy of type II diabetes: A progressive disease. U.K. Prospective Diabetes Study Group. Diabetes. 1995, 44: 1249-1258. 10.2337/diabetes.44.11.1249.
18.
Nathan DM, Cleary PA, Backlund JY, Genuth SM, Lachin JM, Orchard TJ, Raskin P, Zinman B: Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N Engl J Med. 2005, 353: 2643-2653. 10.1056/NEJMoa052187.CrossRefPubMed
19.
Gilmer TP, O'Connor PJ, Manning WG, Rush WA: The cost to health plans of poor glycemic control. Diabetes Care. 1997, 20: 1847-1853. 10.2337/diacare.20.12.1847.CrossRefPubMed
20.
Lorig K, Ritter PL, Villa F, Piette JD: Spanish diabetes self-management with and without automated telephone reinforcement: two randomized trials. Diabetes Care. 2008, 31: 408-414. 10.2337/dc07-1313.CrossRefPubMed
21.
Bandura A: Self-Efficacy: The Exercise of Control. 1997, New York: WHFreeman and Company
22.
Ockene JK, Quirk ME, Goldberg RJ, Kristeller J, Donnelly G, Kalan KL, Gould B, Greene HL, Harrison-Atlas R, Pease J, Pickens S, Williams J: A residents' training program for the development of smoking intervention skills. Arch Intern Med. 1988, 148: 1039-1045. 10.1001/archinte.148.5.1039.CrossRefPubMed
23.
Ockene JK, Ockene IS, Quirk ME, Hebert JR, Saperia GM, Luippold RS, Merriam PA, Ellis S: Physician training for patient-centered nutrition counseling in a lipid intervention trial. Preventive medicine. 1995, 24: 563-570. 10.1006/pmed.1995.1090.CrossRefPubMed
24.
Ockene JK, Wheeler EV, Adams A, Hurley TG, Hebert J: Provider training for patient-centered alcohol counseling in a primary care setting. Arch Intern Med. 1997, 157: 2334-2341. 10.1001/archinte.157.20.2334.CrossRefPubMed
25.
Cheatham JB: TUTOR: A Collaborative Approach to Literacy Instruction. 1993, Syracuse, NY: Literacy Volunteers of America Inc
26.
Doak CC, Doak LG, Root JH: Teaching Patients with Low Literacy Skills. 1996, Philadelphia, PA: Lippincott-Raven Publishers, 2
27.
Kolb DA: Learning-Style Inventory (LSI-IIa). 1993, Boston, MA: McBer & Company
28.
Rosal MC, Olendzki B, Reed GW, Gumieniak O, Scavron J, Ockene IS: Diabetes self-management among low-income Spanish speaking patients: A pilot study. Ann Behav Med. 2005, 29: 225-235. 10.1207/s15324796abm2903_9.CrossRefPubMed
29.
von Goeler DS, Rosal MC, Ockene JK, Scavron J, de Torrijos F: Self-management of type 2 diabetes: A survey of low income urban Puerto Ricans. Diabetes Educ. 2003, 29: 663-672. 10.1177/014572170302900412.CrossRefPubMed
30.
Glasgow RE, Osteen VL: Evaluating diabetes education. Are we measuring the most important outcomes?. Diabetes Care. 1992, 15: 1423-1432. 10.2337/diacare.15.10.1423.CrossRefPubMed
31.
Paul G: Behavior modification research: Design and tactics. Behavior Therapy: Appraisal and Status. Edited by: Franks C. 1969, New York: McGraw-Hill, 29-62.
32.
Hebert JR, Hurley TG, Chiriboga DE, Barone J: A comparison of selected nutrient intakes derived from three diet assessment methods used in a low-fat maintenance trial. Public Health Nutrition. 1998, 1: 207-214.PubMed
33.
Beaton GH, Milner J, Corey P, McGuire V, Cousins M, Stewart E, de Ramos M, Hewitt D, Grambsch PV, Kassim N, Little JA: Sources of variance in 24-hour dietary recall data: Implications for nutrition study design and interpretation. Am J Clin Nutr. 1979, 32: 2546-2549.PubMed
34.
Beaton GH, Milner J, McGuire V, Feather TE, Little JA: Source of variance in 24-hour dietary recall data: Implications for nutrition study design and interpretation. Carbohydrate sources, vitamins, and minerals. Am J Clin Nutr. 1983, 37: 986-995.PubMed
35.
Krantzler NJ, Mullen BJ, Schutz HG, Grevetti LE, Holden CA, Meiselman HL: Validity of telephoned diet recalls and records for assessment of individual food intake. Am J Clin Nutr. 1982, 36: 1234-1242.PubMed
36.
Emmons L, Hayes M: Accuracy of 24 hour recalls of young children. J Am Diet Assoc. 1973, 62: 409-415.PubMed
37.
Matthews CE, DuBose KD, LaMonte M, Tudor-Locke C, Ainsworth BE: Evaluation of a computerized 24-hour physical activity recall (24PAR). [abstract]. Med Sci Sports Exer. 2002, 34: S41-10.1097/00005768-200205001-00236.CrossRef
38.
Matthews CE, Freedson PS, Hebert JR, Stanek EJ, Merriam PA, Ockene IS: Comparing physical activity assessment methods in the Seasonal Variation of Blood Cholesterol Study. Med Sci Sports Exerc. 2000, 32: 976-984. 10.1097/00005768-200005000-00015.CrossRefPubMed
39.
Matthews CE, Freedson PS, Hebert JR, Stanek EJ, Merriam PA, Rosal MC, Ebbeling CB, Ockene IS: Seasonal variation in household, occupational, and leisure time physical activity: Longitudinal analyses from the Seasonal Variation of Blood Cholesterol Study. Am J Epidemiol. 2001, 153: 172-183. 10.1093/aje/153.2.172.CrossRefPubMed
40.
Gagliardino JJ, Etchegoyen G: A model educational program for people with type 2 diabetes: a cooperative Latin American implementation study (PEDNID-LA). Diabetes Care. 2001, 24: 1001-1007. 10.2337/diacare.24.6.1001.CrossRefPubMed
41.
Sawyer-Radloff L: The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977, 1: 385-401. 10.1177/014662167700100306.CrossRef
42.
Radloff LS, Locke BZ: The community mental health assessment survey and the CES-D scale. Community Surveys. Edited by: Weissman MM, Myers J, Ross C. 1986, New York: Prodist Publishers, 177-189.
43.
Radloff LS, Teri L: Use of the Center for Epidemiological Studies Depression Scale with older adults. Clinical Gerontologists. 1986, 5: 119-135. 10.1300/J018v05n01_06.CrossRef
44.
Keyserling TC, Ammerman AS, Samuel-Hodge CD, Ingram AF, Skelly AH, Elasy TA, Johnston LF, Cole AS, Henriquez-Roldan CF: A diabetes management program for African American women with type 2 diabetes. Diabetes Educ. 2000, 26: 796-805. 10.1177/014572170002600508.CrossRefPubMed
45.
Speight J, Bradley C: The ADKnowl: Identifying knowledge deficits in diabetes care. Diabet Med. 2001, 18: 626-633. 10.1046/j.1464-5491.2001.00537.x.CrossRefPubMed
46.
Hurley AC, Shea CA: Self-efficacy: Strategy for enhancing diabetes self-care. Diabetes Educ. 1992, 18: 146-150. 10.1177/014572179201800208.CrossRefPubMed
47.
Bernal H, Woolley S, Schensul JJ, Dickinson JK: Correlates of self-efficacy in diabetes self-care among Hispanic adults with diabetes. Diabetes Educ. 2000, 26: 673-680. 10.1177/014572170002600415.CrossRefPubMed
48.
Bradley C, Todd C, Gorton T, Symonds E, Martin A, Plowright R: The development of an individualized questionnaire measure of perceived impact of diabetes on quality of life: The ADDQoL. Qual Life Res. 1999, 8: 79-91. 10.1023/A:1026485130100.CrossRefPubMed
49.
Bradley C, Speight J: Patient perceptions of diabetes and diabetes therapy: Assessing quality of life. Diabetes Metab Res Rev. 2002, 18: S64-69. 10.1002/dmrr.279.CrossRefPubMed
50.
Ware JE, Kosinski M, Keller SD: SF-12: How to Score the SF-12 Physical and Mental Health Summary Scales. 1995, Boston, MA: The Health Institute, New England Medical Center, 2
51.
Cohen S, Kamark T, Mermelstein R: A global measure of perceived stress. J Health Soc Behav. 1983, 24: 385-396. 10.2307/2136404.CrossRefPubMed
52.
Ryan P: Random allocation of treatment in blocks. Stata Journal. 2008, 8: 146-
53.
Littell RC, Milliken GA, Stroup WW, Wolfinger RD: SAS System for Mixed Models. 1996, Cary, NC: SAS Institute, Inc
Metadata
Title
Design and methods for a randomized clinical trial of a diabetes self-management intervention for low-Income Latinos: Latinos en Control
Authors
Milagros C Rosal
Mary Jo White
Angela Restrepo
Barbara Olendzki
Jeffrey Scavron
Elise Sinagra
Ira S Ockene
Michael Thompson
Stephenie C Lemon
Lucy M Candib
George Reed
Publication date
01-12-2009
Publisher
BioMed Central
Published in
BMC Medical Research Methodology / Issue 1/2009
Electronic ISSN: 1471-2288
DOI
https://doi.org/10.1186/1471-2288-9-81

Other articles of this Issue 1/2009

BMC Medical Research Methodology 1/2009 Go to the issue

Research article

Extending an evidence hierarchy to include topics other than treatment: revising the Australian 'levels of evidence'

Research article

Effectiveness and cost of recruitment strategies for a community-based randomised controlled trial among rainwater drinkers

Software

Meta-Analyst: software for meta-analysis of binary, continuous and diagnostic data

Research article

Assessment of regression-based methods to adjust for publication bias through a comprehensive simulation study

Research article

Deploying a clinical innovation in the context of actor-patient consultations in general practice: A prelude to a formal clinical trial

Research article

Strategies for achieving a high response rate in a home interview survey