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

NCT ID: NCT00693511

Last Updated: 2017-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2012-08-31

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.

Conditions

Obesity and Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Circuit Training

Participants received CT exercise training two times per week for approximately 60-90 min per session for 16 wk

Group Type: EXPERIMENTAL

Circuit Training

Intervention Type: BEHAVIORAL

Circuit Training (aerobic + strength training 2 times per week for 16 weeks)

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

Group Type: EXPERIMENTAL

Circuit training + motivational interviewing

Intervention Type: BEHAVIORAL

Circuit training (aerobic + strength training 2 times per week for 16 weeks) + motivational interviewing (4 individual + 4 group sessions)

Control

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Circuit Training

Circuit Training (aerobic + strength training 2 times per week for 16 weeks)

Intervention Type: BEHAVIORAL

Circuit training + motivational interviewing

Circuit training (aerobic + strength training 2 times per week for 16 weeks) + motivational interviewing (4 individual + 4 group sessions)

Intervention Type: BEHAVIORAL

Other Intervention Names

CT; CT + MI

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jaimie N Davis, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Veronica Atkins Lifestyle Intervention Laboratory

Los Angeles, California, United States

Countries

United States

References

Davis JN, Gyllenhammer LE, Vanni AA, Meija M, Tung A, Schroeder ET, Spruijt-Metz D, Goran MI. Startup circuit training program reduces metabolic risk in Latino adolescents. Med Sci Sports Exerc. 2011 Nov;43(11):2195-203. doi: 10.1249/MSS.0b013e31821f5d4e.

Reference Type: RESULT

PMID: 21502883 (View on PubMed)

Davis JN, Le KA, Walker RW, Vikman S, Spruijt-Metz D, Weigensberg MJ, Allayee H, Goran MI. Increased hepatic fat in overweight Hispanic youth influenced by interaction between genetic variation in PNPLA3 and high dietary carbohydrate and sugar consumption. Am J Clin Nutr. 2010 Dec;92(6):1522-7. doi: 10.3945/ajcn.2010.30185. Epub 2010 Oct 20.

Reference Type: DERIVED

PMID: 20962157 (View on PubMed)

Other Identifiers

K01DK078858

Identifier Type: NIH

Identifier Source: secondary_id

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K01DK078858

Identifier Type: NIH

Identifier Source: org_study_id

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