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

Primary Purpose

Obesity and Type 2 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Circuit Training

Circuit training + motivational interviewing

About this trial

This is an interventional prevention trial for Obesity and Type 2 Diabetes focused on measuring obesity, adolescents, adiposity, insulin sensitivity, type 2 diabetes, Latino, circuit training, physical activity, motivational interviewing

Eligibility Criteria

14 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Veronica Atkins Lifestyle Intervention Laboratory

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Circuit Training

Circuit training + motivational interviewing

Control

Arm Description

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

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

No intervention

Outcomes

Primary Outcome Measures

Insulin sensitivity

Secondary Outcome Measures

Change in waist circumference

Change in subcutaneous abdominal adipose tissue

Change in visceral abdominal adipose tissue

Full Information

NCT ID

NCT00693511

First Posted

June 5, 2008

Last Updated

September 20, 2017

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT00693511

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

August 31, 2010 (Actual)

Study Completion Date

August 31, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity and Type 2 Diabetes

Keywords

obesity, adolescents, adiposity, insulin sensitivity, type 2 diabetes, Latino, circuit training, physical activity, motivational interviewing

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Circuit Training

Arm Type

Experimental

Arm Description

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

Arm Title

Circuit training + motivational interviewing

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

No intervention

Intervention Type

Behavioral

Intervention Name(s)

Circuit Training

Other Intervention Name(s)

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Circuit training + motivational interviewing

Other Intervention Name(s)

CT + MI

Intervention Description

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

Primary Outcome Measure Information:

Title

Insulin sensitivity

Time Frame

post intervention (week 16)

Secondary Outcome Measure Information:

Title

Change in waist circumference

Time Frame

post-intervention (week 16)

Title

Change in subcutaneous abdominal adipose tissue

Time Frame

post-intervention (week 16)

Title

Change in visceral abdominal adipose tissue

Time Frame

post-intervention (week 16)

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaimie N Davis, PhD, RD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veronica Atkins Lifestyle Intervention Laboratory

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21502883

Citation

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.

Results Reference

result

PubMed Identifier

20962157

Citation

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.

Results Reference

derived

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

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