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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693511
First Posted: June 9, 2008
Last Update Posted: September 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  Purpose

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.


Condition Intervention
Obesity and Type 2 Diabetes Behavioral: Circuit Training Behavioral: Circuit training + motivational interviewing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Circuit Training and Motivational Interviewing to Reduce Type 2 Diabetes in Youth

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: post intervention (week 16) ]

Secondary Outcome Measures:
  • 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) ]

Enrollment: 45
Study Start Date: October 2007
Study Completion Date: August 31, 2012
Primary Completion Date: August 31, 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Circuit Training
Participants received CT exercise training two times per week for approximately 60-90 min per session for 16 wk
Behavioral: Circuit Training
Circuit Training (aerobic + strength training 2 times per week for 16 weeks)
Other Name: CT
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
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
No Intervention: Control
No intervention

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693511


Locations
United States, California
Veronica Atkins Lifestyle Intervention Laboratory
Los Angeles, California, United States, 90033
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Jaimie N Davis, PhD, RD University of Southern California
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00693511     History of Changes
Other Study ID Numbers: K01DK078858 ( U.S. NIH Grant/Contract )
First Submitted: June 5, 2008
First Posted: June 9, 2008
Last Update Posted: September 22, 2017
Last Verified: September 2017

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
obesity
adolescents
adiposity
insulin sensitivity
type 2 diabetes
Latino
circuit training
physical activity
motivational interviewing

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases