Clinical trial NCT04052815: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pre Diabetes
Obesity
Keywords: pre-diabetes
female
Diabetes type 2
Hispanic/Latino
community based programs
diabetes prevention program
Lead sponsor: Loyola University
Sponsor class: OTHER
First posted: 2019-08-12
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Change from Baseline Weight at 12 month
timeFrame: 12 months
measure: Change from Baseline waist circumference at 12 months
timeFrame: 12 months
measure: Change from Baseline Glycated hemoglobin at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from Baseline low density lipoprotein (LDL) at 12 months
timeFrame: 12 months
measure: Change from baseline High-density lipoprotein (HDL) at 12 months
timeFrame: 12 months
measure: Dietary assessment for fruits and vegetables
timeFrame: baseline, 16 weeks, 12 months
measure: Dietary assessment of fat consumption
timeFrame: baseline, 16 weeks, 12 months
Other outcomes:
measure: 7-day physical activity recall
timeFrame: baseline, 16 weeks, 12 months
measure: Perceived self-efficacy
timeFrame: baseline, 16 weeks, 12 months
measure: Rosenberg self-esteem
timeFrame: baseline and 12 months
Locations:
city: Maywood
country: United States
facility: Quinn Center
state: Illinois
Study officials:
affiliation: Loyola University Chicago
name: Nallely Mora, MD, MPH
role: PRINCIPAL_INVESTIGATOR
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