NCT02615353

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
117

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2015

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 26, 2015

Completed
6 months until next milestone

Study Start

First participant enrolled

May 13, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2020

Completed
Last Updated

October 14, 2022

Status Verified

October 1, 2022

Enrollment Period

3.8 years

First QC Date

November 4, 2015

Last Update Submit

October 12, 2022

Conditions

ObesityDiabetes

Outcome Measures

Primary Outcomes (2)

  • Glucose Tolerance

    Change in 2 hour glucose concentration following a 75 gram Oral Glucose Tolerance Test

    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).

    6-months, 12-months

Secondary Outcomes (2)

  • Youth Quality of Life

    6-months, 12-months

  • Body Composition

    6-months, 12-months

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

6 months of a bi-weekly Nutrition Education, Physical Activity, and Behavioral Modification program

Behavioral: Intensive Lifestyle Intervention

Usual Care Control

PLACEBO COMPARATOR

Medical screening and dietary counseling with a Endocrinologist and Registered Dietitian

Other: Usual Care Control

Interventions

Intensive Lifestyle InterventionBEHAVIORAL

6-months of lifestyle education

Lifestyle Intervention
Usual Care ControlOTHER

Medical visit and dietary counseling

Also known as: Control
Usual Care Control

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Related Publications (4)

  • 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.

    PMID: 28302101BACKGROUND

  • Pena 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.

    PMID: 36094502DERIVED

  • Vander 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.

    PMID: 34865631DERIVED

  • Vander 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.

    PMID: 32799920DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2015

First Posted

November 26, 2015

Study Start

May 13, 2016

Primary Completion

March 15, 2020

Study Completion

March 15, 2020

Last Updated

October 14, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Locations

US(1)