Strength and Nutrition Outcomes for Latino Adolescents
SANO LA
Intra-Abdominal Fat and Risk of Disease in Adolescents
1 other identifier
interventional
104
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started May 2005
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 16, 2008
CompletedMarch 31, 2017
March 1, 2017
2.1 years
June 11, 2008
March 29, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
insulin sensitivity
post intervention (week 16)
Secondary Outcomes (1)
adiposity
post-intervention (week 16)
Study Arms (4)
1
NO INTERVENTIONControl (C)
2
EXPERIMENTALNutrition (N)
3
EXPERIMENTALStrength Training \& Nutrition (ST + N)
4
EXPERIMENTALCircuit Training \& Nutrition (CT + N)
Interventions
Nutrition classes for 1 hour \& 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)
Strength Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour \& 30 minutes for 16 weeks + motivational interviewing (4 individual \& 4 group sessions)
Circuit Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour \& 30 minutes for 16 weeks + motivational interviewing (4 individual \& 4 group sessions)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Veronica Atkins Lifestyle Intervention Laboratory
Los Angeles, California, 90033-9073, United States
Related Publications (6)
Gyllenhammer 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: 23836520DERIVEDHasson 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: 23818490DERIVEDLe 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: 22025778DERIVEDLe 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: 21270204DERIVEDDavis 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: 20962157DERIVEDVentura 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.
PMID: 19349560DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael I Goran, PhD
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 16, 2008
Study Start
May 1, 2005
Primary Completion
June 1, 2007
Study Completion
July 1, 2007
Last Updated
March 31, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share