Obesity and Type 2 DiabetesNCT00693511
Circuit Training and Motivational Interviewing to Reduce Type 2 Diabetes in Youth
A study testing Circuit Training and Circuit training + motivational interviewing in people with Obesity and Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity and Type 2 Diabetes
- What is being tested?
- Circuit Training and Circuit training + motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to 31 Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veronica Atkins Lifestyle Intervention Laboratory
Los Angeles, California, 90033
About this study
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)
Read more
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
- Being tested
- Circuit Training, Circuit training + motivational interviewing
- Keywords
- obesity, adolescents, adiposity, insulin sensitivity, type 2 diabetes, Latino, circuit training, physical activity, motivational interviewing
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circuit TrainingBehavioural
Also called CT
Circuit Training (aerobic + strength training 2 times per week for 16 weeks)
Circuit training + motivational interviewingBehavioural
Also called CT + MI
Circuit training (aerobic + strength training 2 times per week for 16 weeks) + motivational interviewing (4 individual + 4 group sessions)
| Study group | Role | What they receive |
|---|---|---|
| Circuit Training | Experimental | Participants received CT exercise training two times per week for approximately 60-90 min per session for 16 wk Receives: Behavioral: Circuit Training |
| Circuit training + motivational interviewing | Experimental | 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 Receives: Behavioral: Circuit training + motivational interviewing |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
Measured: post intervention (week 16)
Secondary outcomes (3)
Change in waist circumference
Measured: post-intervention (week 16)
Change in subcutaneous abdominal adipose tissue
Measured: post-intervention (week 16)
Change in visceral abdominal adipose tissue
Measured: post-intervention (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2008 (estimated)
- Study startOct 2007
- Primary completion31 Aug 2010
- Study completion31 Aug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity and Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jaimie N Davis, PhD, RD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00693511
- Sponsor's protocol ID
- K01DK078858
- Other IDs
- K01DK078858
- Status last verified
- Sep 2017
- First submitted
- 5 Jun 2008
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21502883Davis 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.
PubMed 20962157
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circuit Training and Motivational Interviewing to Reduce Type 2 Diabetes in Youth
- ClinicalTrials.gov ID
- NCT00693511
- Acronym / sponsor ID
- K01DK078858
- Conditions
- Obesity and Type 2 Diabetes
- Keywords
- obesity, adolescents, adiposity, insulin sensitivity, type 2 diabetes, Latino, circuit training, physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- Oct 2007
- Primary completion
- 31 Aug 2010 (actual)
- Study completion
- 31 Aug 2012 (actual)
- First posted
- 9 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circuit Training | Experimental | Behavioral: Circuit TrainingParticipants received CT exercise training two times per week for approximately 60-90 min per session for 16 wk |
| Circuit training + motivational interviewing | Experimental | Behavioral: Circuit training + motivational interviewingParticipants 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 |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circuit TrainingAlso: CTCircuit Training (aerobic + strength training 2 times per week for 16 weeks) | Behavioural | Circuit Training |
| Circuit training + motivational interviewingAlso: CT + MICircuit training (aerobic + strength training 2 times per week for 16 weeks) + motivational interviewing (4 individual + 4 group sessions) | Behavioural | Circuit training + motivational interviewing |
Primary outcome
Insulin sensitivity
Time frame: post intervention (week 16)
3 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Results publication: PubMed 21502883Davis 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.
- Derived from this study: PubMed 20962157Davis 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.
Related trials for Obesity and Type 2 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Active, not recruitingPhase 3
AMAZE 2: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Type 2 Diabetes Lose Weight
Diabetes Mellitus, Overweight
Not yet recruiting
Use and Acceptability of an AI-Assisted Health Application for Individuals Living With a Chronic Condition
Hypertension, Diabetes Mellitus, Type 2
Not yet recruitingObservational study
Obesity-Related Indices and Albuminuria in Type 2 Diabetes
Obesity and Diabetes Mellitus, Type 2, Albuminuria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaimie N Davis, PhD, RD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circuit Training and Circuit training + motivational interviewing in people with Obesity and Type 2 Diabetes, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: post intervention (week 16)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00693511, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.