Strength and Nutrition Outcomes for Latino Adolescents (SANO LA)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00697580
First received: June 11, 2008
Last updated: July 20, 2011
Last verified: July 2011
  Purpose

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 Intervention
Obesity
Type 2 Diabetes
Cardiovascular Risk
Cancer
Behavioral: Control
Behavioral: Nutrition
Behavioral: Strength Training & Nutrition
Behavioral: Circuit Training & Nutrition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intra-Abdominal Fat and Risk of Disease in Adolescents

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • insulin sensitivity [ Time Frame: post intervention (week 16) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • adiposity [ Time Frame: post-intervention (week 16) ] [ Designated as safety issue: No ]

Estimated Enrollment: 104
Study Start Date: May 2005
Study Completion Date: July 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Control (C)
Behavioral: Control
delayed intervention - they receive intervention classes (ST + N) at the end of the study that is not compared to the other groups.
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00697580

Locations
United States, California
Veronica Atkins Lifestyle Intervention Laboratory
Los Angeles, California, United States, 90033-9073
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: Michael I Goran, PhD University of Southern California
  More Information

No publications provided by University of Southern California

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

Responsible Party: Michael Goran/Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT00697580     History of Changes
Other Study ID Numbers: 5R01HD33064-13, 5R01HD33064-13
Study First Received: June 11, 2008
Last Updated: July 20, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
Obesity
Type 2 Diabetes
Cardiovascular risk
Cancer
Latino
Adolescents
Strength Training
Circuit Training
Nutrition

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 28, 2014