Preventing Diabetes in Latino Families

NCT05228522 | Active Not Recruiting DMC

• 2 other identifiers: R01DK107579-06A11R01DK107579-01
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes; Obesity; Pediatric Obesity

Outcome Measures

Primary Outcomes (1)

• Glucose Tolerance

  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 Outcomes (6)

• Weight Specific Quality of Life (QoL)

  16 weeks

• Total body composition-muscle

  16 weeks

• Total body composition-fat

  16 weeks

• Total body composition-bone

  16 weeks

• Physical Activity

  16 weeks

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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

Behavioral: Lifestyle Intervention

Comparison control

NO INTERVENTION

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.

Interventions

Lifestyle Intervention BEHAVIORAL

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

Lifestyle Intervention

Eligibility Criteria

• Age: 10 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Latino: self-report
• Age: 10-16 years
• Obesity: BMI ≥ 95th percentile for age and sex
• 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
• Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
• Self-identify as American Indian

Sponsors & Collaborators

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

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Obesity; Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2022
• First Posted: February 8, 2022
• Study Start: December 12, 2021
• Primary Completion: January 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)