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

ClinicalTrials.gov processed this record on October 23, 2014