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Circuit Training and Motivational Interviewing to Reduce Type 2 Diabetes in Youth

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ClinicalTrials.gov Identifier: NCT00693511
Recruitment Status : Completed
First Posted : June 9, 2008
Last Update Posted : September 25, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE June 5, 2008
First Posted Date  ICMJE June 9, 2008
Last Update Posted Date September 25, 2017
Study Start Date  ICMJE October 2007
Actual Primary Completion Date August 31, 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
Insulin sensitivity [ Time Frame: post intervention (week 16) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 20, 2017)
  • Change in waist circumference [ Time Frame: post-intervention (week 16) ]
  • Change in subcutaneous abdominal adipose tissue [ Time Frame: post-intervention (week 16) ]
  • Change in visceral abdominal adipose tissue [ Time Frame: post-intervention (week 16) ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2008)
adiposity [ Time Frame: post-intervention (week 16) ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Circuit Training and Motivational Interviewing to Reduce Type 2 Diabetes in Youth
Official Title  ICMJE Circuit Training and Motivational Interviewing to Reduce Type 2 Diabetes in Youth
Brief Summary

The overall goal of this project is to examine the physiological and metabolic effects of a 16-week circuit-training (strength training + aerobic activities) program, with and without a behavioral component utilizing motivational interviewing, in 45 overweight Latina adolescent girls (14-18 years of age). This 16-week randomized control study will examine the incremental effects of the following 3 intervention groups on insulin sensitivity, insulin secretion, adiposity, and habitual and ad libitum physical activity:

  • Control group (delayed circuit training intervention; n=15)
  • Circuit training group (strength + aerobic training; 2 times per week; n=15)
  • Circuit training (same as above) + weekly motivational interviewing sessions (n=15)

Specific Aim 1: To examine the effects of a 16-week circuit training program on adiposity, insulin dynamics, other associated hormones and adipocytokines, cardiorespiratory fitness, and muscular strength in overweight Latina adolescent girls. Hypothesis 1: Participation in the circuit-training program will result in significant improvements in both physiological and metabolic outcomes, including: a) body composition as measured by DEXA, b) fat distribution as measured by MRI, c) adipose tissue hormones (e.g. leptin, adiponectin, TNF-α) as measured by fasting blood samples, d) insulin sensitivity and secretion as measured by frequently sampled intravenous tolerance test, e) aerobic fitness as measured by the single stage submaximal treadmill test, and f) increase muscular strength as measured by repetition maximums.

Specific Aim 2: To examine the incremental effects of adding the motivational interviewing sessions to the circuit training on self-selected ad libitum physical activity during a 5-hour observational period, habitual physical activity levels using 7 day accelerometry, and the meanings and motivation to exercise using questionnaires before and after the intervention. Hypothesis 2: The addition of motivational interviewing will encourage and empower participants to be more active outside of the intervention and foster healthy physical activity behaviors in daily life. Improvements in physical activity behaviors will lead to greater improvements in all other health outcomes listed in specific aim 1 compared to circuit training alone and control group.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Obesity and Type 2 Diabetes
Intervention  ICMJE
  • Behavioral: Circuit Training
    Circuit Training (aerobic + strength training 2 times per week for 16 weeks)
    Other Name: CT
  • Behavioral: Circuit training + motivational interviewing
    Circuit training (aerobic + strength training 2 times per week for 16 weeks) + motivational interviewing (4 individual + 4 group sessions)
    Other Name: CT + MI
Study Arms  ICMJE
  • Experimental: Circuit Training
    Participants received CT exercise training two times per week for approximately 60-90 min per session for 16 wk
    Intervention: Behavioral: Circuit Training
  • Experimental: Circuit training + motivational interviewing
    Participants in the CT + MI group received the same CT classes but also received four individual MI and four group MI sessions throughout the 16-wk program by two trained research staff
    Intervention: Behavioral: Circuit training + motivational interviewing
  • No Intervention: Control
    No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2008)
45
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 31, 2012
Actual Primary Completion Date August 31, 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At Risk of Overweight and Overweight (age- & sex-specific body mass index ≥ 85th percentile based on CDC BMI growth charts [US Department of Health and Human Services, 2000]. There will not be an upper BMI limit. In our experience, we have had numerous children above the 99th percentile for BMI complete the outcome measures, and this group could benefit greatly from participation.
  • Gender & Age: Females from grades 9th to 12th (approximately 14-18 years of age). We chose to study adolescents because pubertal youth will likely possess the requisite hormonal milieu needed to elicit physiologically and metabolic changes in response to resistance and aerobic training. In addition physical activity declines are more pronounced in minority females. By limiting the study to just females, we will retain a more homogenous group. This will eliminate sensitive gender issues related to exercise such as body image concerns, goal setting, and motivations for behavioral changes. To reduce effects of the menstrual cycle, all females will be tested during the follicular phase, while those with irregular/unpredictable menses will be studied at random times.
  • Latino origin all four grandparents must be of Hispanic heritage (reported on screening forms). This approach is consistent with all of our previous and ongoing work.

Exclusion Criteria:

  • Presently taking medication(s) or diagnosed with any syndrome or disease that could influence physical activity, body composition and fat distribution, or insulin action.
  • Previously diagnosed with any major illness since birth (e.g. chronic birth asphyxia, cancer, etc.).
  • Children with type 1 and/or type 2 diabetes will be excluded and referred to a physician. Children with impaired glucose tolerance (fasting glucose >100 mg/dL during a fasting blood draw) and/or conditions associated with insulin resistance (e.g. acanthosis nigricans, hypertension, dyslipidemia) will be eligible, as long as they are not receiving treatment and meet other eligibility criteria.
  • Children who have any physical, cognitive, or psychological disabilities that would prevent them from participating in an exercise program.
  • Currently, or in the past 6 months, involved with any dietary, physical activity or weight loss program.
  • Children who live farther than 20 miles away from the GCRC.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 14 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00693511
Other Study ID Numbers  ICMJE K01DK078858( U.S. NIH Grant/Contract )
K01DK078858 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jaimie N Davis, PhD, RD University of Southern California
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP