Overweight/Obesity
Conditions
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).
Interventions
BEHAVIORALActive Living
Participants will be provided with education and support for diet and lifestyle modification related to healthy eating and active living.
OTHERHealth and Safety
Participants will be provided with education related to general health and safety topics.
Sponsors
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
7 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from 0 to 12 months in Body Mass Index (BMI) | 12 months |
| Change from 0 to 12 months in fasting insulin | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from 0 to 12 months in BMI z-score | 12 months |
| Change from 0 to 12 months in waist circumference | 12 months |
| Change from 0 to 12 months in hemoglobin A1c | 12 months |
| Change from 0 to 12 months in fasting glucose | 12 months |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from 0 to 12 months in fruit/vegetable intake | 12 months | Proportion consuming 5+ servings of fruits/vegetables daily |
| Potential for sustained delivery | 12 months | Qualitative factors related to potential for sustained delivery |
| Change from 0 to 12 months in physical activity | 12 months | Proportion engaging in 1+ hour of moderate-vigorous physical activity daily |
| Change from 0 to 12 months in screen time | 12 months | Proportion watching 2 hours or less of screen time daily |
| Change from 0 to 12 months in sugary beverage intake | 12 months | Proportion consuming 0 servings of sugary beverages daily |
| Participant engagement | 12 months | Qualitative factors related to participant engagement |
| Program implementation | 12 months | Qualitative factors related to program implementation |
Countries
United States
Outcome results
None listed