Preventing Diabetes in Latino Families
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- 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
- 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-muscle [16 weeks]
Muscle (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).
- 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).
- 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.
- Dietary behaviors [16 weeks]
Dietary behaviors will be assessed using the NCI Dietary Screener Questionnaire.
Eligibility Criteria
Criteria
Inclusion/Exclusion Criteria - Children
Inclusion
-
Latino: self-report
-
Age: 10-16 years
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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
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Currently enrolled in (or within previous 12 months) a formal diabetes prevention or weight loss program
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Self-identify as American Indian
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Unstable depression or other mental health condition that may impact QoL
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Arizona State University | Phoenix | Arizona | United States | 85004 |
Sponsors and Collaborators
- Arizona State University
- Phoenix Children's Hospital
- St. Vincent de Paul Medical and Dental Clinic
- Valley of the Sun YMCA, Arizona
- University of Washington
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- R01DK107579-06A1