Strength Training and Nutrition Development for African American Youth (STAND)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Southern California
ClinicalTrials.gov Identifier:
NCT01441323
First received: September 23, 2011
Last updated: September 26, 2011
Last verified: September 2011
  Purpose

The investigators 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 African American youth. Sixty 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), or 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). The investigators 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: USC Center for Transdisciplinary Research on Energetics and Cancer or Obesity-Related Metabolic Disease Risk: Response to Exercise in Minority Youth

Resource links provided by NLM:


Further study details as provided by University of Southern California:

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

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

Enrollment: 62
Study Start Date: June 2007
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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: Nutrition (N) Behavioral: Nutrition
Nutrition classes for 1 hour & 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)
Experimental: Strength Training & Nutrition (ST) 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)

  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 (≥85th BMI percentile)
  • African American: Children will initially be defined as African American if they and both parents and all 4 grandparents self identify as African American.

Exclusion Criteria:

  • Diabetes: 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 OGTT using a dose of 1.75g glucose/kg BW (to a maximum of 75g). 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 >100 mg/dL or 2-hour glucose >140 mg/dl during an oral glucose tolerance test) and/or conditions associated with insulin resistance (e.g. acanthosis nigricans, hypertension, dyslipidemia, poly-cystic ovarian syndrome) will be eligible, as long as they are not receiving treatment and meet other eligibility criteria.
  • Weight loss or exercise program: currently involved with any weight loss or exercise program, or have been in the 6 months prior to participation
  • Use of medications: taking any medications known to influence body composition or insulin action/secretion (e.g. prednisone, ritalin, growth hormone)
  • Syndromes that influence body composition: diagnosed with syndromes or diseases that may influence body composition and fat distribution (e.g. Cushing syndrome, Down syndrome)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441323

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

No publications provided

Responsible Party: University of Southern California
ClinicalTrials.gov Identifier: NCT01441323     History of Changes
Other Study ID Numbers: 195-1642394A1, 1 U54 CA116848
Study First Received: September 23, 2011
Last Updated: September 26, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of Southern California:
Obesity
Type 2 Diabetes
Cardiovascular Risk
Cancer
African American
Adolescents
Strength 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 April 15, 2014