Stress Clinical Trial
— UNITEDOfficial title:
Unidos Por la Salud/United for Health: Innovative Community-Academic Partnership for Type 2 Diabetes Prevention
NCT number | NCT03527641 |
Other study ID # | 16-6568 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2018 |
Est. completion date | April 30, 2019 |
Verified date | August 2019 |
Source | Colorado State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 20 |
Est. completion date | April 30, 2019 |
Est. primary completion date | April 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 15 Years |
Eligibility |
Inclusion Criteria: - Age 12-15 years - Identify as Hispanic/Latino - English speaking - At-risk for T2D by virtue of current BMI = 85th percentile for age and sex by CDC 2000 standards and = 1 first or second degree biological relative with T2D, prediabetes, or gestational diabetes - Currently a Salud Family Health Center patient or willing to become a patient of Salud Family Health Center (required to complete medical assessments at Salud) Exclusion Criteria: - Major medical problem, including type 1 diabetes or T2D - Reported psychiatric disorder that would impede compliance in the opinion of the investigators - Started use of medication affecting mood or body weight, such as stimulants or anti-depressants within the past 3 months - Any medical issues that could be acutely worsened by exercise such as severe or uncontrolled asthma or musculoskeletal problems - Self-reported pregnancy in girls |
Country | Name | City | State |
---|---|---|---|
United States | Colorado State University | Fort Collins | Colorado |
United States | Salud Family Health Center | Fort Collins | Colorado |
Lead Sponsor | Collaborator |
---|---|
Colorado State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility of Recruitment/Enrollment | Feasibility of recruitment/enrollment for community-based family lifestyle intervention for Latino teens at-risk for type 2 diabetes as measured by number of qualifying participants following screening | Up to 12 week period preceding the start of the intervention | |
Primary | Treatment Acceptability Questionnaire | Survey adapted from the Treatment Acceptability Questionnaire to assess acceptability and satisfaction with program participation; items are rated on a scale ranging from 1-5 with higher scores reflecting more positive acceptability | 6 weeks | |
Primary | Perceived Stress Scale | Survey assessing perceptions of stress; the total score, calculated as the sum of all items, ranges from 0 to 60, with higher values reflecting more perceived stress | 6 months | |
Primary | Homeostasis model assessment of insulin resistance (HOMA-IR) | Poor sensitivity of insulin to respond to and regulate glucose (blood sugar) as estimated from fasting glucose and insulin values | 6 months | |
Secondary | Mindful Attention Awareness Scale | Survey assessing propensity for present-moment attention; a total score is calculated as the sum of all items with a possible range of 15-90, with higher scores reflecting greater mindfulness (positive outcome) and lower scores, less mindfulness (worse outcome) | 6 months | |
Secondary | Center for Epidemiologic Studies-Depression Scale | Survey measure of symptoms of depression; a total score is calculated as the sum of all items with a possible range of 0-60, with higher scores reflecting more depressive symptoms | 6 months | |
Secondary | Emotional Eating Scale Adapted for Children and Adolescents | Survey measure of eating in response to negative emotions; subscales include eating in response to depression, eating in response to anger/anxiety/frustration, and eating in response to boredom with subscales calculated as the average of items; subscales range from 1-5 with higher scores indicating more emotional eating | 6 months | |
Secondary | Actigraph GT3x Sleep Time | Total sleep time as assessed by wrist-worn accelerometry | 6 months | |
Secondary | Actigraph GT3x Physical Activity | Total amount of minutes spent in light, moderate, and vigorous activity as assessed by wrist-worn accelerometry | 6 months | |
Secondary | Cortisol | Stress hormone as assessed by salivary swab | 6 weeks | |
Secondary | Everyday Discrimination Scale | Survey assessing perceived impact of discrimination; a total score is calculated from the sum of all items, with the total score ranging from 1 to 54, with higher scores indicating higher levels of perceived discrimination | 6 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05130944 -
Feasibility of Community Psychosocial Intervention for Women
|
N/A | |
Recruiting |
NCT06079853 -
Nurse Suicide: Physiologic Sleep Health Promotion Trial
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Recruiting |
NCT04038190 -
A Behavioral Activation Intervention Administered in a College Freshman Orientation Course
|
Phase 2 | |
Completed |
NCT03931772 -
Online Automated Self-Hypnosis Program
|
N/A | |
Active, not recruiting |
NCT05998161 -
Evaluating the Effectiveness of a Digital Therapeutic (Reviga) for People With Stress or Burnout
|
N/A | |
Completed |
NCT03728062 -
Mindfulness Meditation Versus Physical Exercise: Comparing Effects on Stress and Immunocompetence
|
N/A | |
Terminated |
NCT04367636 -
The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19
|
N/A | |
Completed |
NCT06405789 -
The Effect of Yoga on Mindfulness and Perceived Stress
|
N/A | |
Recruiting |
NCT06002074 -
SMART Program Impact on Quality of Life in Inflammatory Bowel Diseases
|
N/A | |
Recruiting |
NCT05273996 -
Predictors of Cognitive Outcomes in Geriatric Depression
|
Phase 4 | |
Completed |
NCT05245409 -
Stress, EEG, ECG, and Chiropractic
|
N/A | |
Completed |
NCT04722367 -
Being Present With Art: The Impact of Mindful Engagement With Art on Awareness and Connection
|
N/A | |
Recruiting |
NCT06273228 -
Parenting Young Children in Pediatrics
|
N/A | |
Completed |
NCT06057883 -
Effects Of A Probiotic Formulation On Stress and Skin Health in Younger Adult Females
|
Phase 2 | |
Completed |
NCT05063305 -
Probiotics, Immunity, Stress, and QofL
|
N/A | |
Completed |
NCT05312749 -
The Effect of Web Based Progressive Muscle Relaxation Exercise on Clinical Stress and Anxiety of Nursing Students
|
N/A | |
Completed |
NCT05623826 -
Feasibility and Efficacy of a Digital Training Intervention to Increase Reward Sensitivity- Imager
|
N/A | |
Completed |
NCT04013451 -
The Kiss of Kindness Study II
|
N/A |