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NCT Number: NCT05228522

Preventing Diabetes in Latino Families

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

10 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifestyle Intervention

Behavioral

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2022
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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