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| ID | Type | Description | Link |
|---|---|---|---|
| 5P20MD002316-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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The purpose of this study is to examine the effects of 12 week lifestyle intervention on diabetes risk in obese Latino adolescents.
Obesity in the United States has reached epidemic proportions and Latinos youth are disproportionally impacted. Pediatric obesity is associated with several chronic health conditions including insulin resistance and type 2 diabetes. However, very few interventions specifically targeting diabetes prevention for obese Latino adolescents have been developed.
Therefore, the purpose of this study is to examine the effects a culturally-grounded, community-based lifestyle intervention on psychosocial and health outcomes among obese Latino adolescents. Eligible participants of this study will be randomly selected to the intervention group or the delayed-intervention group (control group) after an initial health screening for eligibility.
Participants selected to the intervention group will attend weekly healthy lifestyle education sessions with their parent(s)/guardian(s) and three physical activity sessions / week with other youth. After which, participants will attend monthly booster group meetings for three months.
All participants will be assessed at baseline, 3 months, 6 months, and 12 months for insulin sensitivity, glucose tolerance, quality of life, fitness, and nutrition and physical activity behaviors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Every Little Step Counts Intervention | Experimental | Exercise classes (3/week) Lifestyle sessions (1/week) |
|
| Delayed ELSC Intervention Group | No Intervention | Control group (delayed intervention group) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Every Little Step Counts Intervention | Other | Youth participants randomized to participate in the experimental group will attend weekly healthy lifestyles education session with their parent(s)/guardian(s) and will also attend exercise sessions 3 times a week for 12 weeks. The education sessions will cover topics such as healthy eating choices, roles and responsibilities of both parents and youth in the realm of the family unit as well as in youth's own health, and self esteem among other topics. The exercise sessions will incorporate both aerobic and resistance training as well as other "free-play" physical activities i.e. basketball, volleyball etc. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insulin Sensitivity / Glucose Tolerance, Measured at Baseline, Change 3-months, 6-months, and 12-months | Proximal indicator of diabetes risk | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline |
| Change in Quality of Life Measured at Baseline, 3-months, 6-months, and 12-months | Generic and weight-specific quality of life | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self efficacy for healthy eating and exercise | These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the "mediated effect" on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: self-efficacy for healthy eating and exercise. | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Initial incremental cost effectiveness of intervention vs. standard care | Analysis will be conducted on the initial incremental cost effectiveness of the intervention compared to no intervention on changes in insulin sensitivity and prevention of diabetes. | Analysis for the outcome is expected to occur approximately 4 years after the initial baseline testing. Data for analysis will be consist of one year ELSC cost. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gabriel Q Shaibi, PhD | Arizona State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona State University | Phoenix | Arizona | 85003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28104469 | Background | Williams AN, Konopken YP, Keller CS, Castro FG, Arcoleo KJ, Barraza E, Patrick DL, Olson ML, Shaibi GQ. Culturally-grounded diabetes prevention program for obese Latino youth: Rationale, design, and methods. Contemp Clin Trials. 2017 Mar;54:68-76. doi: 10.1016/j.cct.2017.01.004. Epub 2017 Jan 16. | |
| 30426694 | Result | Soltero EG, Olson ML, Williams AN, Konopken YP, Castro FG, Arcoleo KJ, Keller CS, Patrick DL, Ayers SL, Barraza E, Shaibi GQ. Effects of a Community-Based Diabetes Prevention Program for Latino Youth with Obesity: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Dec;26(12):1856-1865. doi: 10.1002/oby.22300. Epub 2018 Nov 14. |
| Label | URL |
|---|---|
| PI's Research Webpage | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D003920 | Diabetes Mellitus |
| D063766 | Pediatric Obesity |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
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| Change in Social support from family and friends on healthy eating and exercise. | These secondary outcomes measures aim to explore the mechanisms of the intervention by assessing the "mediated effect" on the outcomes of insulin sensitivity and weight-specific QoL through the following putative mediators targeted in the program: Social support from family and friends on healthy eating and exercise. | Baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline |
| 30342918 | Result | Olson ML, Renteria-Mexia A, Connelly MA, Vega-Lopez S, Soltero EG, Konopken YP, Williams AN, Castro FG, Keller CS, Yang HP, Todd MW, Shaibi GQ. Decreased GlycA after lifestyle intervention among obese, prediabetic adolescent Latinos. J Clin Lipidol. 2019 Jan-Feb;13(1):186-193. doi: 10.1016/j.jacl.2018.09.011. Epub 2018 Sep 22. |
| 30588900 | Result | Renteria-Mexia A, Vega-Lopez S, Olson ML, Swan PD, Lee CD, Williams AN, Shaibi GQ. Effects of a lifestyle intervention on markers of cardiometabolic risk and oxidized lipoproteins among obese adolescents with prediabetes. Public Health Nutr. 2019 Mar;22(4):706-713. doi: 10.1017/S1368980018003476. Epub 2018 Dec 27. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |