Recruiting

Observational Study

Sponsor:

Loyola University

Code:

NCT04052815

Conditions

Pre Diabetes

Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Diabetes prevention program culturally tailored

Study Details

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

Study ID

NCT04052815

Start date

Jan 1, 2020

Status verified date

Apr, 2021

Completion date

Dec 30, 2022

Anticipated

Primary completion date

Dec 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Diabetes prevention program culturally tailored

Adult females with Hispanic background

Interventions

Diabetes prevention program culturally tailored

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

  • Change from Baseline Weight at 12 month [ Time Frame: 12 months ]
  • Change from Baseline waist circumference at 12 months [ Time Frame: 12 months ]
  • Change from Baseline Glycated hemoglobin at 12 months [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Quinn Center

Recruiting

Maywood, Illinois, United States, 60153

Contacts

Kristen K Mighty, PhD, MPH

708-397-6111director@quinncenter.org

More Information

Sponsor

Loyola University

Last update posted

Apr 23, 2021

Last verified

Apr, 2021

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Loyola University on 2021-04-23.