Preventing Diabetes in Latino Families

NCT ID: NCT05228522

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

132 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-12

Study Completion Date

2026-07-31

Brief Summary

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Purpose: This study will test the efficacy of a family-focused lifestyle intervention for reducing type 2 diabetes (T2D) risk factors and increasing Quality of Life (QoL) among high-risk Latino families.

Detailed Description

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Background: T2D disproportionately impacts Latino children, families and communities. The Diabetes Prevention Program (DPP) established that T2D can be prevented in high-risk adults through intensive lifestyle intervention. Although the DPP has been translated to a variety of adult populations and settings, engagement and effectiveness is diminished in minority communities and there are no family-focused diabetes prevention trials for Latinos. The culturally-grounded approach is guided by an Ecodevelopmental model that considers community, family, peer, and individual-level factors that influence health behaviors and health outcomes over time. The study will test the efficacy of a 16-week family-focused lifestyle intervention for reducing T2D risk and increasing QoL among high-risk Latino families as compared to control families. The study will use Integrative Mixed Methods to understand how family structures and processes influence intervention outcomes.

Conditions

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Type 2 Diabetes Obesity Pediatric Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Lifestyle Intervention

16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.

Group Type EXPERIMENTAL

Lifestyle Intervention

Intervention Type BEHAVIORAL

16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.

Comparison control

Comparison control families meet with the Study Physician and a Registered Dietitian as a family to review laboratory results and receive lifestyle counseling. Control families will be contacted on a monthly basis for a total of 12 months.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lifestyle Intervention

16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Exclusion Criteria

Inclusion

* Latino: self-report
* Age: 10-16 years
* Obesity: BMI ≥ 95th percentile for age and sex

Exclusion

* Type 2 diabetes: (standard American Diabetes Association criteria)
* Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, physical activity, and/or cognition
* Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
* Self-identify as American Indian
* Unstable depression or other mental health condition that may impact QoL


Inclusion


Exclusion

* Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
* Self-identify as American Indian
Minimum Eligible Age

10 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St. Vincent de Paul Medical and Dental Clinic

OTHER

Sponsor Role collaborator

Valley of the Sun YMCA, Arizona

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Arizona State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona State University

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DK107579-01

Identifier Type: NIH

Identifier Source: secondary_id

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R01DK107579-06A1

Identifier Type: NIH

Identifier Source: org_study_id

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