Obesity, Pediatric Obesity, Type 2 Diabetes
Conditions
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.
Interventions
BEHAVIORALLifestyle Intervention
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
Sponsors
Arizona State University
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)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 ((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. |
Countries
United States
Outcome results
None listed