Strength Training and Nutrition Development for African American Youth

NCT01441323 | Completed DMC

• 2 other identifiers: 195-1642394A11U54CA116848
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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 African American 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.

Conditions

Obesity; Type 2 Diabetes; Cardiovascular Risk; Cancer

Keywords

Obesity; Type 2 Diabetes; Cardiovascular Risk; Cancer; African American; Adolescents; Strength Training; Nutrition

Outcome Measures

Primary Outcomes (1)

• insulin sensitivity

  post interventive (week 16)

Secondary Outcomes (1)

• adiposity

  post intervention (week 16)

Study Arms (3)

Control (C)

NO INTERVENTION

Nutrition (N)

EXPERIMENTAL

Behavioral: Nutrition

Strength Training & Nutrition (ST)

EXPERIMENTAL

Behavioral: Strength Training & Nutrition

Interventions

Nutrition BEHAVIORAL

Nutrition classes for 1 hour \& 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)

Nutrition (N)

Strength Training & Nutrition BEHAVIORAL

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)

Strength Training & Nutrition (ST)

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Veronica Atkins Lifestyle Intervention Laboratory

Los Angeles, California, 90033, United States

Location

Related Publications (1)

• Hijazin K, Smith B, Garrett C, Knox A, Kelly LA. Relationship between adiponectin and blood pressure in obese Latino adolescent boys with a family history of type 2 diabetes. BMC Pediatr. 2023 Oct 20;23(1):523. doi: 10.1186/s12887-023-04337-y.

  PMID: 37864156 DERIVED

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Neoplasms

Interventions

Nutritional Status; Resistance Training

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael I Goran, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2011
• First Posted: September 27, 2011
• Study Start: June 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: March 31, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)