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Strength and Nutrition Outcomes for Latino Adolescents (SANO LA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00697580
Recruitment Status : Completed
First Posted : June 16, 2008
Last Update Posted : March 31, 2017
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Type 2 Diabetes Cardiovascular Risk Cancer Behavioral: Nutrition Behavioral: Strength Training & Nutrition Behavioral: Circuit Training & Nutrition

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intra-Abdominal Fat and Risk of Disease in Adolescents
Study Start Date : May 2005
Primary Completion Date : June 2007
Study Completion Date : July 2007

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: 1
Control (C)
Experimental: 2
Nutrition (N)
Behavioral: Nutrition
Nutrition classes for 1 hour & 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)
Experimental: 3
Strength Training & Nutrition (ST + N)
Behavioral: Strength Training & Nutrition
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)
Experimental: 4
Circuit Training & Nutrition (CT + N)
Behavioral: Circuit Training & Nutrition
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)

Outcome Measures

Primary Outcome Measures :
  1. insulin sensitivity [ Time Frame: post intervention (week 16) ]

Secondary Outcome Measures :
  1. adiposity [ Time Frame: post-intervention (week 16) ]

Eligibility Criteria

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00697580

United States, California
Veronica Atkins Lifestyle Intervention Laboratory
Los Angeles, California, United States, 90033-9073
Sponsors and Collaborators
University of Southern California
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Michael I Goran, PhD University of Southern California
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Michael I. Goran, Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT00697580     History of Changes
Other Study ID Numbers: 5R01HD033064 ( U.S. NIH Grant/Contract )
First Posted: June 16, 2008    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Michael I. Goran, University of Southern California:
Type 2 Diabetes
Cardiovascular risk
Strength Training
Circuit Training

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases