Strength and Nutrition Outcomes for Latino Adolescents (SANO LA)
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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 |
- insulin sensitivity [ Time Frame: post intervention (week 16) ] [ Designated as safety issue: No ]
- 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 |
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| United States, California | |
| Veronica Atkins Lifestyle Intervention Laboratory | |
| Los Angeles, California, United States, 90033-9073 | |
| 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:
|
Obesity Overweight Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Overnutrition Nutrition Disorders Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013