Preventing Diabetes in Latino Families

Obesity Clinical Trial

Official title:

Preventing Diabetes in Latino Families

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05228522
• Other study ID #: R01DK107579-06A1
• Secondary ID: 1R01DK107579-01
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2021
• Est. completion date: July 31, 2026

Study information

• Verified date: June 2024
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: July 31, 2026
• Est. primary completion date: January 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity
• Pediatric Obesity
• Type 2 Diabetes

Intervention

Behavioral:
• Lifestyle Intervention
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (6)

Lead Sponsor	Collaborator
Arizona State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Phoenix Children's Hospital, St. Vincent de Paul Medical and Dental Clinic, University of Washington, Valley of the Sun YMCA, Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight Specific Quality of Life (QoL)	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
Secondary	Total body composition-muscle	Muscle (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).	16 weeks
Secondary	Total body composition-fat	Fat (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).	16 weeks
Secondary	Total body composition-bone	Bone density (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).	16 weeks
Secondary	Physical Activity	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
Secondary	Dietary behaviors	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