Community Based DPP Program for Hispanic/Latino Females

NCT04052815 | Unknown

• 1 other identifier: 212259
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Is well known that obesity is increasing in the United States (US) and particularly among Hispanic/ especially in in socially disadvantaged groups. Studies have shown that the prevalence of metabolic syndrome is about 1.5 times higher among Mexican American females living in the US compared to non-Hispanic females. Culturally among Hispanic/Latino females some activities like grocery shopping and meal cooking in households that most likely impact other family members. Culturally grounded interventions can be made readily tailored and translated into real-world settings by utilizing collaborative, community based participatory approaches. The overall objective of this study is to offer a diabetes prevention program to the community, targeting adult females with Hispanic/Latino background population that could benefit from a sustainable change behavior program to reduce the risk of developing Type 2 Diabetes, metabolic syndrome and cardiovascular disease. Sessions will be conducted in Spanish or English according to participants' preferences. The program format is to meet for one year. Cadence will be once a week for the next 16 weeks (Core curriculum), then once a month (maintenance curriculum). In addition to the DPP curriculum a structured physical activity component will be added, with the objective of facilitating achievement of program goals. Other culturally tailored activities will be included like: grocery shopping, recipes community walking maps and other available community resources. In addition the investigators will utilize a qualitative approach to gather information about project's feasibility and acceptability. To do so, investigators plan to conduct 60 minutes focus groups and semi structured interviews at the end of the 16 week core-program and at the end of the program (program participants and staff members).

Conditions

Pre Diabetes; Obesity

Keywords

pre-diabetes; female; Diabetes type 2; Hispanic/Latino; community based programs; diabetes prevention program

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Weight at 12 month

  weight in lb

  12 months

• Change from Baseline waist circumference at 12 months

  waist circumference in centimeters

  12 months

• Change from Baseline Glycated hemoglobin at 12 months

  Glycated hemoglobin (HbA1C)

  12 months

Secondary Outcomes (4)

• Change from Baseline low density lipoprotein (LDL) at 12 months

  12 months

• Change from baseline High-density lipoprotein (HDL) at 12 months

  12 months

• Dietary assessment for fruits and vegetables

  baseline, 16 weeks, 12 months

• Dietary assessment of fat consumption

  baseline, 16 weeks, 12 months

Other Outcomes (3)

• 7-day physical activity recall

  baseline, 16 weeks, 12 months

• Perceived self-efficacy

  baseline, 16 weeks, 12 months

• Rosenberg self-esteem

  baseline and 12 months

Study Arms (1)

Diabetes prevention program culturally tailored

EXPERIMENTAL

Adult females with Hispanic background

Behavioral: Diabetes prevention program culturally tailored

Interventions

Diabetes prevention program culturally tailored BEHAVIORAL

Diabetes prevention Program (DPP) as specified by the CDC, physical activity prior to DPP sessions, motivational interviewing individual and in group. Culturally tailored nutrition tips and recipes.

Diabetes prevention program culturally tailored

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hispanic/Latino background, female, ≥18 years old, with Body mass index (BMI) ≥25 or Glycated hemoglobin (Hb1AC) and/or glucose on parameter to be considered pre-diabetic.

You may not qualify if:

• to have a diagnosis of diabetes, taking medication for diabetes, conditions that impedes mobilization, mental impairment, or conditions that impede to be under diet restrictions.

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Quinn Center

Maywood, Illinois, 60153, United States

RECRUITING

Related Publications (13)

• Wyatt SB, Winters KP, Dubbert PM. Overweight and obesity: prevalence, consequences, and causes of a growing public health problem. Am J Med Sci. 2006 Apr;331(4):166-74. doi: 10.1097/00000441-200604000-00002.

  PMID: 16617231 BACKGROUND

• Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: estimates for the year 2000 and projections for 2030. Diabetes Care. 2004 May;27(5):1047-53. doi: 10.2337/diacare.27.5.1047.

  PMID: 15111519 BACKGROUND

• Ervin RB. Prevalence of metabolic syndrome among adults 20 years of age and over, by sex, age, race and ethnicity, and body mass index: United States, 2003-2006. Natl Health Stat Report. 2009 May 5;(13):1-7.

  PMID: 19634296 BACKGROUND

• Acosta-Cordova, The Latino Neighborhood report: issues and prospects for Chicago. Institute for research on race and public policy, Great city Institute, University of Illinois at Chicago. , 2017.

  BACKGROUND

• Arbona C, Olvera N, Rodriguez N, Hagan J, Linares A, Wiesner M. Acculturative Stress Among Documented and Undocumented Latino Immigrants in the United States. Hisp J Behav Sci. 2010 Aug;32(3):362-384. doi: 10.1177/0739986310373210.

  PMID: 25484488 BACKGROUND

• Shobe MA, Coffman MJ, Dmochowski J. Achieving the American dream: facilitators and barriers to health and mental health for Latino immigrants. J Evid Based Soc Work. 2009 Jan;6(1):92-110. doi: 10.1080/15433710802633601.

  PMID: 19199139 BACKGROUND

• Katy M. Pinto, V.O., Beyond Cultural Explanations: Understanding the Gendered Division of Household Labor in Mexican American Families. Journal of Family Issues, 2018. 39(16).

  BACKGROUND

• Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• Centers for Disease, C.a.P., Diabetes prevention Recognition program: standards and operating procedures, Atlanta (GA). US Department of Health and Human Services, 2011.

  BACKGROUND

• Satterfield DW, Volansky M, Caspersen CJ, Engelgau MM, Bowman BA, Gregg EW, Geiss LS, Hosey GM, May J, Vinicor F. Community-based lifestyle interventions to prevent type 2 diabetes. Diabetes Care. 2003 Sep;26(9):2643-52. doi: 10.2337/diacare.26.9.2643.

  PMID: 12941733 BACKGROUND

• Viswanathan M, Ammerman A, Eng E, Garlehner G, Lohr KN, Griffith D, Rhodes S, Samuel-Hodge C, Maty S, Lux L, Webb L, Sutton SF, Swinson T, Jackman A, Whitener L. Community-based participatory research: assessing the evidence. Evid Rep Technol Assess (Summ). 2004 Aug;(99):1-8. No abstract available.

  PMID: 15460504 BACKGROUND

• Wallerstein N, Duran B. Community-based participatory research contributions to intervention research: the intersection of science and practice to improve health equity. Am J Public Health. 2010 Apr 1;100 Suppl 1(Suppl 1):S40-6. doi: 10.2105/AJPH.2009.184036. Epub 2010 Feb 10.

  PMID: 20147663 BACKGROUND

• Wakimoto P, Block G, Mandel S, Medina N. Development and reliability of brief dietary assessment tools for Hispanics. Prev Chronic Dis. 2006 Jul;3(3):A95. Epub 2006 Jun 15.

  PMID: 16776896 BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance; Obesity; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Nallely Mora, MD, MPH

  Loyola University Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nallely Mora, MD, MPH

CONTACT

708-327-9030; namora@luc.edu

Amy Luke, PhD

CONTACT

708-327-9018; aluke@luc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 12, 2019
• Study Start: January 1, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2022
• Last Updated: April 23, 2021

Record last verified: 2021-04

Locations

US (1)