Preventing Diabetes in Latino Families
Primary Purpose
Type 2 Diabetes, Obesity, Pediatric Obesity
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lifestyle Intervention
Sponsored by
About this trial
This is an interventional prevention trial for Type 2 Diabetes
Eligibility 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/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
Sites / Locations
- Arizona State UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lifestyle Intervention
Comparison control
Arm Description
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
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).
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).
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).
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.
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.
Full Information
NCT ID
NCT05228522
First Posted
January 5, 2022
Last Updated
February 16, 2023
Sponsor
Arizona State University
Collaborators
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)
1. Study Identification
Unique Protocol Identification Number
NCT05228522
Brief Title
Preventing Diabetes in Latino Families
Official Title
Preventing Diabetes in Latino Families
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2021 (Actual)
Primary Completion Date
April 3, 2024 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arizona State University
Collaborators
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)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes, Obesity, Pediatric Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle Intervention
Arm Type
Experimental
Arm Description
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
Arm Title
Comparison control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Intervention
Intervention Description
16-week family-focused intervention that includes nutrition education, behavioral change skills training, and physical activity.
Primary Outcome Measure Information:
Title
Glucose Tolerance
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Weight Specific Quality of Life (QoL)
Description
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).
Time Frame
16 weeks
Title
Total body composition-muscle
Description
Muscle (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).
Time Frame
16 weeks
Title
Total body composition-fat
Description
Fat (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).
Time Frame
16 weeks
Title
Total body composition-bone
Description
Bone density (grams) will be assessed by Dual-energy X-Ray Absorptiometry (DXA) using the GE Lunar iDXA (GE Lunar, Madison, WI).
Time Frame
16 weeks
Title
Physical Activity
Description
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.
Time Frame
16 weeks
Title
Dietary behaviors
Description
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.
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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/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
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mayra L Tornel, MS
Phone
602-496-0194
Email
mltornel@asu.edu
First Name & Middle Initial & Last Name & Degree
Allison Williams, MSW
Phone
602-496-0147
Email
Allison.nagle@asu.edu
First Name & Middle Initial & Last Name & Degree
Gabriel Q Shaibi, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We will share aggregate data but no individual participant data will be shared with other researchers.
Learn more about this trial
Preventing Diabetes in Latino Families
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