ObesityNCT02615353
Preventing Diabetes in Latino Youth
A study testing Intensive Lifestyle Intervention in people with Obesity and Diabetes, run by Arizona State University at 1 site in United States.
Trial summary
Obesity and type 2 diabetes are critical public health issues in youth. This study will test the effects and estimate the cost-effectiveness of a culturally-grounded community-based lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with prediabetes. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- What is being tested?
- Intensive Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2016to 15 Mar 2020
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Latino: self-report
- Age: 12-16
- Obese: BMI percentile ≥95th percentile for age and gender or BMI ≥30 kg/m22
- Prediabetic: fasting glucose ≥100, or 2-hour post-OGTT glucose ≥120 mg/dl, or HbA1c ≥5.7
Who cannot join
- Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, PA, and/or cognition
- Type 2 diabetes: Fasting glucose ≥126 mg/dl or 2-hour glucose ≥200 mg/dl, or HbA1c ≥6.5
- Recent Hospitalization (previous 2 months)
- Currently enrolled in (or within previous 6 months) a formal weight loss program.
- Diagnosed depression or other condition that may impact QoL
Trial locations and contacts
1 site in 1 country.
About this study
Obesity and type 2 diabetes are critical public health issues in youth. This study will test the effects and estimate the cost-effectiveness of a culturally-grounded community-based lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with prediabetes.
Read the detailed description
Obesity and related health disparities represent some of the most significant public health challenges facing society. In particular, obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. The Diabetes Prevention Program established that lifestyle intervention can prevent or delay type 2 diabetes in adults with prediabetes. To date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, investigators propose a randomized-controlled trial to test the short-term (6-month) and long-term (12-month) efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes. Investigators will further test intervention effects on changes in quality of life, explore the potential mediating effects of changes in total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost-effectiveness of the intervention as compared with usual care for improving glucose tolerance. The overall approach is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence when changes in health behaviors and health outcomes are linked to future health trajectories. The intervention is guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. The proposal builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution-oriented programs to prevent type 2 diabetes in this and other populations of high-risk youth.
- Being tested
- Intensive Lifestyle Intervention, Usual Care Control
- Medical subject headings
- Obesity, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Lifestyle InterventionBehavioural
6-months of lifestyle education
Usual Care ControlOther
Also called Control
Medical visit and dietary counseling
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Intervention | Experimental | 6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program Receives: Behavioral: Intensive Lifestyle Intervention |
| Usual Care Control | Placebo comparator | Medical screening and dietary counseling with a Endocrinologist and Registered Dietitian Receives: Other: Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose Tolerance
Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test
Measured: 6-months, 12-months
Insulin Sensitivity
Change in Insulin Sensitivity following a 75 gram Oral Glucose Tolerance Test. Insulin sensitivity will be estimated by the Whole-body insulin sensitivity index (Matsuda Index).
Measured: 6-months, 12-months
Secondary outcomes (2)
Youth Quality of Life
YQOL has domains of self (feelings about one's self), social relationships (friends and family), environment (social and cultural milieu) are assessed and an overall QoL score is computed. The instrument shows strong psychometric properties including internal consistency (Chronbach's alpha >0.80), test-retest reliability (ICC >0.74), and construct validity with other pediatric QoL measures (r = 0.73, P<0.05 with KINDL). Weight specific QoL will be assessed by the YQOL-W which, measures three domains of weight-related QoL (Self, Social, and Environmental). It is specific to obese adolescents (11-18 years) for use in evaluating weight management interventions in clinical and community research. The instrument shows good reliability (ICC =0.77) and construct validity with the children's depression inventory (r=0.57, P<0.01) in adolescents and is more sensitive then generic measures for detecting changes in QoL among obese youth participating in lifestyle interventions.
Measured: 6-months, 12-months
Body Composition
Change in fat mass and increase in lean tissue mass by DXA
Measured: 6-months, 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2015 (estimated)
- Study start13 May 2016
- Primary completion15 Mar 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe 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
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Collaborators
- Phoenix Children's Hospital, St. Vincent de Paul Medical and Dental Clinic, Valley of the Sun YMCA, Arizona, University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02615353
- Sponsor's protocol ID
- 1R01DK107579-01
- Other IDs
- 3R01DK107579-03S1
- Status last verified
- Oct 2022
- First submitted
- 4 Nov 2015
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Soltero EG, Konopken YP, Olson ML, Keller CS, Castro FG, Williams AN, Patrick DL, Ayers S, Hu HH, Sandoval M, Pimentel J, Knowler WC, Frick KD, Shaibi GQ. Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial. BMC Public Health. 2017 Mar 16;17(1):261. doi: 10.1186/s12889-017-4174-2.
PubMed 28302101Pena A, Olson ML, Hooker E, Ayers SL, Castro FG, Patrick DL, Corral L, Lish E, Knowler WC, Shaibi GQ. Effects of a Diabetes Prevention Program on Type 2 Diabetes Risk Factors and Quality of Life Among Latino Youths With Prediabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231196. doi: 10.1001/jamanetworkopen.2022.31196.
PubMed 36094502Vander Wyst KB, Olson ML, Bailey SS, Valencia AM, Pena A, Miller J, Shub M, Seabrooke L, Pimentel J, Olsen K, Rosenberg RB, Shaibi GQ. Communicating incidental and reportable findings from research MRIs: considering factors beyond the findings in an underrepresented pediatric population. BMC Med Res Methodol. 2021 Dec 5;21(1):275. doi: 10.1186/s12874-021-01459-8.
PubMed 34865631Vander Wyst KB, Olson ML, Hooker E, Soltero EG, Konopken YP, Keller CS, Castro FG, Williams AN, Fernandez ADR, Patrick DL, Ayers SL, Hu HH, Pena A, Pimentel J, Knowler WC, Shaibi GQ. Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population. Trials. 2020 Aug 14;21(1):716. doi: 10.1186/s13063-020-04658-8.
PubMed 32799920
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Diabetes in Latino Youth
- ClinicalTrials.gov ID
- NCT02615353
- Acronym / sponsor ID
- 1R01DK107579-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Collaborators
- Phoenix Children's Hospital, St. Vincent de Paul Medical and Dental Clinic, Valley of the Sun YMCA, Arizona, University of Washington, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 13 May 2016 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 26 Nov 2015 (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.
Obesity and type 2 diabetes are critical public health issues in youth. This study will test the effects and estimate the cost-effectiveness of a culturally-grounded community-based lifestyle intervention on type 2 diabetes risk among obese Latino adolescents with prediabetes.
Detailed description
Obesity and related health disparities represent some of the most significant public health challenges facing society. In particular, obese Latino adolescents are disproportionately impacted by insulin resistance and type 2 diabetes. Prediabetes is an intermediate stage in the pathogenesis of type 2 diabetes and represents a critical opportunity for intervention. The Diabetes Prevention Program established that lifestyle intervention can prevent or delay type 2 diabetes in adults with prediabetes. To date, no diabetes prevention studies have been conducted in obese Latino youth with prediabetes, a highly vulnerable and underserved group. Therefore, investigators propose a randomized-controlled trial to test the short-term (6-month) and long-term (12-month) efficacy of a culturally-grounded, lifestyle intervention, as compared to usual care, for improving glucose tolerance and reducing diabetes risk in 120 obese Latino adolescents with prediabetes. Investigators will further test intervention effects on changes in quality of life, explore the potential mediating effects of changes in total, regional, and organ fat on improving glucose tolerance and increasing insulin sensitivity, and estimate the initial incremental cost-effectiveness of the intervention as compared with usual care for improving glucose tolerance. The overall approach is framed within a multilevel Ecodevelopmental model that leverages community, family, peer, and individual factors during the critical transition period of adolescence when changes in health behaviors and health outcomes are linked to future health trajectories. The intervention is guided by Social Cognitive Theory and employs key behavioral modification strategies to enhance self-efficacy and foster social support for making and sustaining healthy behavior changes. The proposal builds upon extant collaborations of a transdisciplinary team of investigators working in concert with local community agencies to address critical gaps in how diabetes prevention interventions for obese Latino youth are developed, implemented and evaluated. This innovative approach is an essential step in the development of scalable, cost-effective, solution-oriented programs to prevent type 2 diabetes in this and other populations of high-risk youth.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Intervention | Experimental | Behavioral: Intensive Lifestyle Intervention6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program |
| Usual Care Control | Placebo comparator | Other: Usual Care ControlMedical screening and dietary counseling with a Endocrinologist and Registered Dietitian |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Latino: self-report
- Age: 12-16
- Obese: BMI percentile ≥95th percentile for age and gender or BMI ≥30 kg/m22
- Prediabetic: fasting glucose ≥100, or 2-hour post-OGTT glucose ≥120 mg/dl, or HbA1c ≥5.7
Key exclusion criteria (5 listed)
- Taking medication(s) or diagnosed with a condition that influences carbohydrate metabolism, PA, and/or cognition
- Type 2 diabetes: Fasting glucose ≥126 mg/dl or 2-hour glucose ≥200 mg/dl, or HbA1c ≥6.5
- Recent Hospitalization (previous 2 months)
- Currently enrolled in (or within previous 6 months) a formal weight loss program.
- Diagnosed depression or other condition that may impact QoL
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 |
|---|---|---|
| Intensive Lifestyle Intervention6-months of lifestyle education | Behavioural | Lifestyle Intervention |
| Usual Care ControlAlso: ControlMedical visit and dietary counseling | Other | Usual Care Control |
Primary outcome
Glucose Tolerance
Time frame: 6-months, 12-months
Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test
Insulin Sensitivity
Time frame: 6-months, 12-months
Change in Insulin Sensitivity following a 75 gram Oral Glucose Tolerance Test. Insulin sensitivity will be estimated by the Whole-body insulin sensitivity index (Matsuda Index).
2 secondary outcomes
Youth Quality of Life
Time frame: 6-months, 12-months
Body Composition
Time frame: 6-months, 12-months
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 14 Oct 2022.
- Background: PubMed 28302101Soltero EG, Konopken YP, Olson ML, Keller CS, Castro FG, Williams AN, Patrick DL, Ayers S, Hu HH, Sandoval M, Pimentel J, Knowler WC, Frick KD, Shaibi GQ. Preventing diabetes in obese Latino youth with prediabetes: a study protocol for a randomized controlled trial. BMC Public Health. 2017 Mar 16;17(1):261. doi: 10.1186/s12889-017-4174-2.
- Derived from this study: PubMed 36094502Pena A, Olson ML, Hooker E, Ayers SL, Castro FG, Patrick DL, Corral L, Lish E, Knowler WC, Shaibi GQ. Effects of a Diabetes Prevention Program on Type 2 Diabetes Risk Factors and Quality of Life Among Latino Youths With Prediabetes: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231196. doi: 10.1001/jamanetworkopen.2022.31196.
- Derived from this study: PubMed 34865631Vander Wyst KB, Olson ML, Bailey SS, Valencia AM, Pena A, Miller J, Shub M, Seabrooke L, Pimentel J, Olsen K, Rosenberg RB, Shaibi GQ. Communicating incidental and reportable findings from research MRIs: considering factors beyond the findings in an underrepresented pediatric population. BMC Med Res Methodol. 2021 Dec 5;21(1):275. doi: 10.1186/s12874-021-01459-8.
- Derived from this study: PubMed 32799920Vander Wyst KB, Olson ML, Hooker E, Soltero EG, Konopken YP, Keller CS, Castro FG, Williams AN, Fernandez ADR, Patrick DL, Ayers SL, Hu HH, Pena A, Pimentel J, Knowler WC, Shaibi GQ. Yields and costs of recruitment methods with participant phenotypic characteristics for a diabetes prevention research study in an underrepresented pediatric population. Trials. 2020 Aug 14;21(1):716. doi: 10.1186/s13063-020-04658-8.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Lifestyle Intervention in people with Obesity and Diabetes, run by Arizona State University 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 4 inclusion and 5 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 14 Oct 2022. 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. Some participants in this study may receive a placebo. 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?
Glucose Tolerance (time frame: 6-months, 12-months). The study lists 2 primary outcomes in all. 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 NCT02615353, which also lists 4 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 14 Oct 2022.