Clinical trial · Interventional
Strength and Nutrition Outcomes for Latino Adolescents
Intra-Abdominal Fat and Risk of Disease in Adolescents
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
We are conducting an intervention study to examine the effects of a 16-week exercise and diet interventions on prevention of disease, specifically type 2 diabetes and heart disease, in Latino youth. Eighty overweight Latino boys and girls will be recruited and placed in one of the following intervention groups: 1) Control Group (delayed intervention), 2) Dietary Education Group (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake), 3) Combination of Strength Training (twice/week for 60 min, progressive increases in exercise volume and intensity) + Dietary Education (nutrition education focused on reducing sugar \& soda, increased fiber \& whole grain intake) or 4) Combination of Circuit Training (twice/week for 60 min, aerobic + strength training exercises) + Dietary Education (same as above). We will assess which intervention group has the most effects on health parameters such as weight, body composition, and insulin related measures.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Cardiovascular Risk | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Type 2 Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circuit Training & Nutrition | Behavioral | — | UNRESOLVED |
| Nutrition | Behavioral | — | UNRESOLVED |
| Strength Training & Nutrition | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- NO_INTERVENTION
- label
- 1
- description
- Control (C)
- type
- EXPERIMENTAL
- label
- 2
- description
- Nutrition (N)
- interventionNames
- Behavioral: Nutrition
- type
- EXPERIMENTAL
- label
- 3
- description
- Strength Training \& Nutrition (ST + N)
- interventionNames
- Behavioral: Strength Training & Nutrition
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Overweight (age- \& sex-specific body mass index ≥ 85th percentile based on CDC BMI growth charts \[US Department of Health and Human Services, 2000\], calculated by Epi Info Software, version 3.3) * Latino (both sets of grandparents must be of Latino heritage as defined by self-report; limited to Latinos to maintain a homogeneous sample and because Latinos are at increased risk of insulin resistance and type 2 diabetes.) If the participant or the parent is unsure of the country of origin of all 4 grandparents they will be excluded from the study. The participants and their families are not asked whether or not their grandparents are undocumented immigrants. Exclusion Criteria: * Presently taking medication(s) or diagnosed with any syndrome or disease that could influence dietary intake, exercise ability, body composition and fat distribution, or insulin action and secretion. * Previously diagnosed with any major illness since birth (e.g. severe intrauterine growth retardation, chronic birth asphyxia, cancer). * Children will not be eligible for participation if they have any diagnostic criteria for diabetes including polyuria, polydipsia with or without unexplained weight loss, fasting plasma glucose \> 126 mg/dl, or a 2-hour plasma glucose \>200 mg/dL during an oral glucose tolerance test. Children will also be excluded if they test positive for diabetes-related auto-antibodies, including ICA512 and GAD. Children testing positive for type 2 diabetes will be referred for treatment. Children with impaired glucose tolerance (fasting glucose \>110 mg/dL or 2-hour glucose \>140 mg/dl during an OGTT) and/or conditions associated with insulin resistance (e.g. acanthosis nigricans, hypertension, dyslipidemia, PCOS) will be eligible, as long as they are not receiving treatment and meet other eligibility criteria. * Participants who are involved in any weight training, exercise, nutrition, or weight loss program or have been in the past 6 months. * Participants that do not follow the rules and guidelines of appropriate conduct during participation, i.e., disruptive behavior, derogatory or racist comments, or any acts of physical violence towards study staff or other participants, and use of illegal substances. The principal investigator Dr. Michael Goran will decide if this conduct warrants exclusion or removal from the study. * Pregnancy test comes out positive. * Children who live further than 20 miles away from the General Clinic Research Center (GCRC). * We can terminate participation if the child fails to follow the rules and guidelines of appropriate behavior and conduct during participation.
References
Publications (6)
- DERIVEDGyllenhammer LE, Alderete TL, Mahurka S, Allayee H, Goran MI. Adipose tissue 11betaHSD1 gene expression, betacell function and ectopic fat in obese African Americans versus Hispanics. Obesity (Silver Spring). 2014 Jan;22(1):14-8. doi: 10.1002/oby.20571. Epub 2013 Sep 10. PMID 23836520
- DERIVEDHasson RE, Adam TC, Davis JN, Watanabe RM, Goran MI. Compensatory responses to insulin resistance in obese African-American and Latina girls. Pediatr Obes. 2013 Dec;8(6):e68-73. doi: 10.1111/j.2047-6310.2013.00184.x. Epub 2013 Jul 2. PMID 23818490
- DERIVEDLe KA, Mahurkar S, Alderete TL, Hasson RE, Adam TC, Kim JS, Beale E, Xie C, Greenberg AS, Allayee H, Goran MI. Subcutaneous adipose tissue macrophage infiltration is associated with hepatic and visceral fat deposition, hyperinsulinemia, and stimulation of NF-kappaB stress pathway. Diabetes. 2011 Nov;60(11):2802-9. doi: 10.2337/db10-1263. PMID 22025778
- DERIVEDLe KA, Ventura EE, Fisher JQ, Davis JN, Weigensberg MJ, Punyanitya M, Hu HH, Nayak KS, Goran MI. Ethnic differences in pancreatic fat accumulation and its relationship with other fat depots and inflammatory markers. Diabetes Care. 2011 Feb;34(2):485-90. doi: 10.2337/dc10-0760. PMID 21270204
- DERIVEDDavis JN, Le KA, Walker RW, Vikman S, Spruijt-Metz D, Weigensberg MJ, Allayee H, Goran MI. Increased hepatic fat in overweight Hispanic youth influenced by interaction between genetic variation in PNPLA3 and high dietary carbohydrate and sugar consumption. Am J Clin Nutr. 2010 Dec;92(6):1522-7. doi: 10.3945/ajcn.2010.30185. Epub 2010 Oct 20. PMID 20962157
- DERIVEDVentura E, Davis J, Byrd-Williams C, Alexander K, McClain A, Lane CJ, Spruijt-Metz D, Weigensberg M, Goran M. Reduction in risk factors for type 2 diabetes mellitus in response to a low-sugar, high-fiber dietary intervention in overweight Latino adolescents. Arch Pediatr Adolesc Med. 2009 Apr;163(4):320-7. doi: 10.1001/archpediatrics.2009.11.