Preventing Diabetes in Latino Families

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; Obesity; Pediatric Obesity
• Interventions: Behavioral: Lifestyle Intervention

• Registration Number: NCT05228522
• Lead Sponsor: Arizona State University

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.

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 Timeline

• Study Start: 2021-12-12
• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-27
• Study First Posted: 2022-02-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-01
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-01-15
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Glucose Tolerance	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 Outcome Measures

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

Trial Locations

Locations (1)

Arizona State University; 🇺🇸 Phoenix, Arizona, United States