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Community Based DPP Program for Hispanic/Latino Females

Primary Purpose

Pre Diabetes, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes prevention program culturally tailored
Sponsored by
Loyola University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre Diabetes focused on measuring pre-diabetes, female, Diabetes type 2, Hispanic/Latino, community based programs, diabetes prevention program

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Quinn CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diabetes prevention program culturally tailored

Arm Description

Adult females with Hispanic background

Outcomes

Primary Outcome Measures

Change from Baseline Weight at 12 month
weight in lb
Change from Baseline waist circumference at 12 months
waist circumference in centimeters
Change from Baseline Glycated hemoglobin at 12 months
Glycated hemoglobin (HbA1C)

Secondary Outcome Measures

Change from Baseline low density lipoprotein (LDL) at 12 months
low density lipoprotein
Change from baseline High-density lipoprotein (HDL) at 12 months
High-density lipoprotein
Dietary assessment for fruits and vegetables
Dietary assessment for fruits and vegetables using a score in which the first-administration times-per-day score on the simple score yielded the following equations Fruit and vegetables times/day=0.34+ Fruit/vegetable simple-1.34. The score obtained could be interpreted as: <13 equals poor, 13-15 =fair, 16-17= good and =>18 excellent. The screener is in relation to the past month consumption of vegetables and fruits and how often do they consume per week a product
Dietary assessment of fat consumption
Dietary assessment of fat consumption The screener is in relation to the past month consumption of fat and how often do they consume per week a product. Scale construct is the first-administration times-per-day score on the simple score yielded the following equations Fat Times/day= 0.16+fat simple-0.48. The score obtained could be interpreted as: =< 18-excellent, 19-24-good, 25-33-fair, >33-poor

Full Information

First Posted
August 6, 2019
Last Updated
April 22, 2021
Sponsor
Loyola University
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1. Study Identification

Unique Protocol Identification Number
NCT04052815
Brief Title
Community Based DPP Program for Hispanic/Latino Females
Official Title
Culturally Adapted Community-based Translational Diabetes Prevention Program for Obese and Pre-diabetic Hispanic/Latino Females
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loyola University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Is well known that obesity is increasing in the United States (US) and particularly among Hispanic/Latinos and African American women especially in in socially disadvantaged groups. Similarly, diabetes mellitus is a health care burden in the US, with associated costs estimated in $174 billion in 2007, and projections for 2030 estimate that about 30 million Americans will have diabetes. 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. Latinos is one of the largest ethnic groups in the Chicago metropolitan region, in Cook county they comprise about 25% of the population (around 1,295,000 people), and of those 75% are of Mexican origin followed by Puerto Rican (13%). In addition 17% of the population in Chicagoland area does not count with health insurance, the Latino community having the higher percent of uninsured population ranging from 18-32%. This puts in disadvantage the Hispanic/Latino population with high risk factors to develop chronic diseases that have proven to be more prevalent amongst them, like T2D and metabolic syndrome. 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. From a public health perspective, these approaches may offer the greater likelihood for closing the obesity related health disparities gap that currently exist among community members in the US population. The Diabetes Prevention Program (DPP), a randomized controlled trial of a lifestyle change program implemented from 1996 through 2002 with up to 5 years of follow up, demonstrated that individuals with prediabetes who achieved between 5-7% weight reduction and participated in regularly physical activity reduced their T2D risk between 58-71%, twice that achieved through medication. Specifically the DPP program has two main goals: weight loss through healthy eating, aiming for 5-7%; and regular physical activity (PA) to improve overall health, aiming for 150 minutes of brisk PA per week. The program is delivered over a year by DPP trained lifestyle coaches. Community-based lifestyle interventions (CBLI) have been proposed as an effective mechanisms to improve the health of local communities through health education and the adoption of healthier behaviors. This community approach rests on the premise that the intervention respects community strengths, is dictated by cultural practices, and depends on meaningful community participation. The overall objective of this study is to offer a diabetes prevention program in one of the nearby communities to Loyola University Health System, targeting a minority population that could highly benefit from a sustainable change behavior program to reduce the risk of developing T2D, metabolic syndrome and cardiovascular disease among identified high risk individuals. Towards these end, the investigators proposed a community based translational diabetes prevention program, and qualitative research methods to evaluate its acceptability, feasibility and effectiveness. This study will used a mixed research methods approach. For each aim the investigators proposed the following methods: Aim1: Implementation of a Pilot Diabetes prevention program targeting Hispanic/Latino females with obesity or pre-diabetes in nearby communities. The investigators will hold community health fairs to increase awareness among community stakeholders and community members about the existence of prevention programs that could benefit their health at long term. The aim is to drive from this events potential participants for the pilot program. The one year long diabetes Prevention program developed by the CDC will be delivered as prescribed in preferred language, which investigators assumed will be Spanish. In addition to the DPP curriculum a structured physical activity component will be added, with the objective of facilitating achievement of program goals. Nutrition education will be delivered focused on traditional Latino foods. In addition to the CDC original DPP the investigators will give a pedometer to each participant, include organized weekly physical activity sessions, community walking maps, and resources in which at low cost participants will be able to reach the program 150 min/week PA goal. Additional reinforcement activities out of class will be offered such as grocery shopping with family members to prepare a healthy family meal, food demonstrations, recipes related to themes will facilitate curriculum integration into day-to-day lifestyle changes. Aim2: Assess the acceptability in this specific community for a community based translational diabetes prevention program. •After 16 weeks of program start, the investigators will carry out focus groups with participants, and semi-structured interviews with lifestyle coaches and key community stakeholders, with the intention to improve program planning and delivery for the next cycle-2020. Aim 3: Gather preliminary data about feasibility and potential effectiveness of a community based translational diabetes prevention program for Hispanic/Latino females in a community setting. •At program conclusion the investigators will carry out a second round of focus groups with participants, and semi-structured interviews with lifestyle coaches. The objective is to learn about barriers and success stories from lifestyle coaches, research team and community members that faced during the different phases of the program. Feedback from program facilitators and participants will help to seek opportunities to improve community based DPP program delivery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre Diabetes, Obesity
Keywords
pre-diabetes, female, Diabetes type 2, Hispanic/Latino, community based programs, diabetes prevention program

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes prevention program culturally tailored
Arm Type
Experimental
Arm Description
Adult females with Hispanic background
Intervention Type
Behavioral
Intervention Name(s)
Diabetes prevention program culturally tailored
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Weight at 12 month
Description
weight in lb
Time Frame
12 months
Title
Change from Baseline waist circumference at 12 months
Description
waist circumference in centimeters
Time Frame
12 months
Title
Change from Baseline Glycated hemoglobin at 12 months
Description
Glycated hemoglobin (HbA1C)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from Baseline low density lipoprotein (LDL) at 12 months
Description
low density lipoprotein
Time Frame
12 months
Title
Change from baseline High-density lipoprotein (HDL) at 12 months
Description
High-density lipoprotein
Time Frame
12 months
Title
Dietary assessment for fruits and vegetables
Description
Dietary assessment for fruits and vegetables using a score in which the first-administration times-per-day score on the simple score yielded the following equations Fruit and vegetables times/day=0.34+ Fruit/vegetable simple-1.34. The score obtained could be interpreted as: <13 equals poor, 13-15 =fair, 16-17= good and =>18 excellent. The screener is in relation to the past month consumption of vegetables and fruits and how often do they consume per week a product
Time Frame
baseline, 16 weeks, 12 months
Title
Dietary assessment of fat consumption
Description
Dietary assessment of fat consumption The screener is in relation to the past month consumption of fat and how often do they consume per week a product. Scale construct is the first-administration times-per-day score on the simple score yielded the following equations Fat Times/day= 0.16+fat simple-0.48. The score obtained could be interpreted as: =< 18-excellent, 19-24-good, 25-33-fair, >33-poor
Time Frame
baseline, 16 weeks, 12 months
Other Pre-specified Outcome Measures:
Title
7-day physical activity recall
Description
Recall instrument that measures the type of physical activity performed during the past 7 days
Time Frame
baseline, 16 weeks, 12 months
Title
Perceived self-efficacy
Description
Perceived self-efficacy by Schwarzer. The total score is calculated by finding the sum of the all items. For the General Self Efficacy, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy
Time Frame
baseline, 16 weeks, 12 months
Title
Rosenberg self-esteem
Description
self report measure that pertain self-worth and self acceptance. Rated on a 4-point Likert-type scale, ranging from 1 (totally disagree) to 4 (totally agree). Items 1, 3, 4, 7, and 10 are positively worded, and items 2, 5, 6, 8, and 9 negatively. Sum scores for all ten items. Keep scores on a continuous scale. Higher scores indicate higher self-esteem.
Time Frame
baseline and 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nallely Mora, MD, MPH
Phone
708-327-9030
Email
namora@luc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Luke, PhD
Phone
708-327-9018
Email
aluke@luc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nallely Mora, MD, MPH
Organizational Affiliation
Loyola University Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Quinn Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristen K Mighty, PhD, MPH
Phone
708-397-6111
Email
director@quinncenter.org

12. IPD Sharing Statement

Citations:
PubMed Identifier
16617231
Citation
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Results Reference
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PubMed Identifier
15111519
Citation
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.
Results Reference
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PubMed Identifier
19634296
Citation
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.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
25484488
Citation
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.
Results Reference
background
PubMed Identifier
19199139
Citation
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.
Results Reference
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Citation
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).
Results Reference
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PubMed Identifier
11832527
Citation
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.
Results Reference
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Citation
Centers for Disease, C.a.P., Diabetes prevention Recognition program: standards and operating procedures, Atlanta (GA). US Department of Health and Human Services, 2011.
Results Reference
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PubMed Identifier
12941733
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
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Citation
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Citation
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Results Reference
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Community Based DPP Program for Hispanic/Latino Females

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