Clinical trial NCT03573856: Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
Official title: Reducing Diabetes Risk Factors in American Indian Children: Tribal Turning Point
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight/Obesity
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-06-29
Enrollment: 188
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate a behavioral intervention designed to reduce risk factors for type 2 diabetes in American Indian youth aged 7-10 years.

Detailed description: The objectives of tis study are to rigorously evaluate the effect of Tribal Turning Point (TTP) on diabetes risk factors in Native youth. The investigators will enroll up to 360 youth who are aged 7-10 years, overweight/obese (BMI \>85th percentile), self-identify as American Indian, and have \>1 parent/primary caregiver willing to actively participate in the program. Within each community, youth will be randomized to the TTP program or a general health and safety control program. The multi-component TTP intervention is a youth-centered adaptation of the Diabetes Prevention Program designed to reduce diabetes risk factors by improving activity and dietary behaviors. Informed by the pediatric weight management literature, the 12-month intervention includes 12 active learning group classes, 7 individual youth/parent motivational interviewing counseling sessions, and community-specific resource toolboxes. In this trial, the investigators will assess the effect of TTP on anthropometric, metabolic, and behavioral risk factors for type 2 diabetes at the end of the intervention (12mo) and after 1 year of follow-up (24mo).

Eligibility criteria: Inclusion Criteria:

* self-identify as American Indian
* BMI \>=85th percentile for age and sex
* have at least one parent/primary caregiver (parent) willing to actively participate

Exclusion Criteria:

* diabetes
* any serious youth/parent health concerns that would interfere with participation
* plans to move out of the area during the study period

Primary outcomes:
measure: Change from 0 to 12 months in Body Mass Index (BMI)
timeFrame: 12 months
measure: Change from 0 to 12 months in fasting insulin
timeFrame: 12 months
Secondary outcomes:
measure: Change from 0 to 12 months in BMI z-score
timeFrame: 12 months
measure: Change from 0 to 12 months in waist circumference
timeFrame: 12 months
measure: Change from 0 to 12 months in hemoglobin A1c
timeFrame: 12 months
measure: Change from 0 to 12 months in fasting glucose
timeFrame: 12 months
Other outcomes:
measure: Change from 0 to 12 months in fruit/vegetable intake
timeFrame: 12 months
measure: Change from 0 to 12 months in physical activity
timeFrame: 12 months
measure: Change from 0 to 12 months in screen time
timeFrame: 12 months
measure: Change from 0 to 12 months in sugary beverage intake
timeFrame: 12 months
measure: Participant engagement
timeFrame: 12 months
measure: Program implementation
timeFrame: 12 months
measure: Potential for sustained delivery
timeFrame: 12 months
Locations:
city: Aurora
country: United States
facility: Childrens Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Katherine Sauder, PhD
role: PRINCIPAL_INVESTIGATOR
References: