Preventing Diabetes in Latino Families

April 24, 2026 updated by: Arizona State University
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Arizona State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 99 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion/Exclusion Criteria - Children

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

II. Inclusion/Exclusion Criteria - Parents

Inclusion

• Parent of a child who meets the above child inclusion/exclusion criteria

Exclusion

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lifestyle Intervention
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
Behavioral: Lifestyle Intervention
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose Tolerance
Time Frame: 16 weeks

Glucose tolerance will be determined using a standard 75-gram Oral Glucose Tolerance Test (OGTT) with samples collected at fasting and 120 minutes for assessment of glucose concentrations. We will follow the OGTT protocol used by the CDC for the NHANES.

Centers for Disease Control. Oral Glucose Tolerance Test (OGTT) Procedures Manual. In: Survey NHaNE, ed2007.
16 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight Specific Quality of Life (QoL)
Time Frame: 16 weeks

Youth Quality of Life (YQOL) inventory shows strong psychometric properties, internal consistency (Chronbach's alpha >0.80), test-retest reliability (ICC > 0.74), and construct validity with other pediatric QoL measures (r = 0.73, P<0.05 with KINDL).

Weight-specific QoL (YQOL-W) measures three domains of weight-related QoL (Self, Social, Environmental). The instrument shows good reliability (ICC = 0.77) and construct validity with the Children's Depression Inventory (r=0.57, P<0.01).

Adults will be assessed using the World Health Organization Brief Quality of Life Instrument, demonstrates good to excellent psychometric properties. Weight-specific QoL in adults will be assessed by the Obesity and Weight-Loss Quality of Life (OWLQOL) instrument which demonstrates strong psychometric properties internal consistency (Chronbach's alpha >0.90), test-retest reliability (ICC > 0.95), and construct validity with other QoL measures (r = 0.53, P<0.05).
16 weeks
Total body composition-muscle
Time Frame: 16 weeks
Muscle (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).
16 weeks
Total body composition-fat
Time Frame: 16 weeks
Fat (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).
16 weeks
Total body composition-bone
Time Frame: 16 weeks
Bone density (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).
16 weeks
Physical Activity
Time Frame: 16 weeks
Physical Activity will be assessed using accelerometers (Actigraph wGT3X-BT) to capture minutes/day of moderate, moderate to vigorous, and vigorous activity over 7-days with >4 days and >10 hours/day determined as valid. Data will be processed and analyzed using ActiLife v6.13 software.
16 weeks
Dietary behaviors
Time Frame: 16 weeks

Dietary behaviors will be assessed using the NCI ((National Cancer Institute) Dietary Screener Questionnaire.

To score the questionnaire, we use the NCI's (National Cancer Institute) scoring algorithms to convert screener responses to estimates of individual dietary intake for fruits and vegetables (cup equivalents), dairy (cup equivalents), added sugars (teaspoon equivalents), whole grains (ounce equivalents), fiber (g), and calcium (mg) with higher values indicating greater intake. For a fuller description of the statistical methods used, see: Thompson FE, Midthune D, Kahle L, Dodd KW. Development and Evaluation of the National Cancer Institute's Dietary Screener Questionnaire Scoring Algorithms. J Nutrition 2017 Jun;147(6):1226-1233.
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arizona State University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Washington
St. Vincent de Paul Medical and Dental Clinic
Valley of the Sun YMCA, Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 12, 2021

Primary Completion (Actual)

January 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 5, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

April 27, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01DK107579-06A1 (U.S. NIH Grant/Contract)
  • 1R01DK107579-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We will share aggregate data but no individual participant data will be shared with other researchers.

IPD Sharing Time Frame

The data will be available by request in writing 12 months after primary outcomes are published.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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