Trials / Completed
CompletedNCT03527641
United for Health: Type 2 Diabetes Prevention in Latino Teens
Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Colorado State University · Academic / Other
- Sex
- All
- Age
- 12 Years – 15 Years
- Healthy volunteers
- Not accepted
Summary
This study pilots the feasibility and acceptability of a family-based lifestyle intervention for decreasing diabetes risk called "Salud sin Barreras" (meaning, "Health without Barriers") delivered in the community to Latino teens at risk for type 2 diabetes. This program combines traditional lifestyle intervention to change eating and physical activity with learning mindfulness-based stress reduction tools. We also are exploring how Salud sin Barreras lowers stress and improves insulin resistance in Latino teens, as compared to lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP).
Detailed description
This study is a comparative effectiveness pilot trial to evaluate the feasibility and acceptability of a 12-session community-delivered, family-based type 2 diabetes preventative lifestyle intervention, delivered over 6 weeks, that includes mindfulness-based stress reduction training - "Salud sin Barreras" (meaning, "Health without Barriers") - in up to 50 Hispanic/Latino adolescents who are at-risk for developing type 2 diabetes. We also will estimate the effectiveness of Salud sin Barreras for lowering perceived stress and improving insulin resistance as compared to a time-matched lifestyle-only intervention, the "La Vida Saludable" (meaning, the Healthy Living Program; HeLP) in Hispanic/Latino adolescents at-risk for type 2 diabetes. In addition, we will estimate the impact of the Salud sin Barreras program, relative to HeLP, on the secondary outcomes of mindfulness, depressive symptoms, disinhibited eating behavior, sleep quality, physical activity, cortisol, and perceived impact of discrimination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | CookingMatters | Nutrition education and hands-on cooking lessons for the whole family |
| BEHAVIORAL | Parent Education | Parenting, physical activity and nutrition education, and family health education for parents |
| BEHAVIORAL | Physical Activity | Physical fitness activities for teens |
| BEHAVIORAL | Health Education | Health knowledge curriculum for adolescents |
| BEHAVIORAL | Mindfulness-based Stress Reduction | Adolescent mindfulness curriculum |
| BEHAVIORAL | Brief Mindfulness Intervention | Parent-based education and experiential learning of mindfulness-based tools |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2019-04-30
- Completion
- 2019-04-30
- First posted
- 2018-05-17
- Last updated
- 2019-08-26
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03527641. Inclusion in this directory is not an endorsement.