Obesity Clinical Trial
— MODIFYOfficial title:
Metabolic Optimization Through Diet/Lifestyle Improvements For Youth (MODIFY)
Verified date | February 2022 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The overarching goal of this study is to evaluate plasma ceramides (Cers) as early nutrition-sensitive biomarkers of metabolic health. The investigators will implement a diet and lifestyle intervention to improve cardiometabolic risk factors and test the corresponding change in Cer levels. The intervention will incorporate: a) family-level engagement, enrolling both adolescents and one parent/adult caretaker (PAC); and b) a behavior change mobile health (m-health) app, which will offer real-time support, education and monitoring of diet and activity.
Status | Active, not recruiting |
Enrollment | 22 |
Est. completion date | December 31, 2022 |
Est. primary completion date | January 19, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 10 Years and older |
Eligibility | Adolescent inclusion criteria: Aged 10 years to 18 years Dyslipidemia (TG/HDL-c >2.5 in non-Black males and >2.0 in females and Black males) Central adiposity (waist to height ratio > 0.5) Willingness to participate Adult inclusion criteria: Parent or adult caregiver of adolescent patient Central adiposity (waist to height ratio >0.5) Willingness to participate Exclusion criteria (adolescent and parent) include - Diabetes, genetic syndrome, stage II hypertension (systolic or diastolic BP > 95th percentile for age, sex, and height percentile + 12mm Hg or > 140/90, whichever is lower for subjects < 13 yr of age, > 140/90 for all > 13 yr of age, including PAC; history of hypertension controlled on stable medication regimen accepted) - Medication use known to affect insulin sensitivity or lipid profiles, including metformin, statins, fibric acids or second generation atypical anti-psychotics (stable doses of stimulant or antidepressant therapy accepted) - Current participation and unwillingness to cease activities related to a diet/exercise lifestyle modification program other than this program - Any medical condition or syndrome with neurocognitive delay that would preclude active participation with the mobile health app - Pregnancy or intention to become pregnant (as this will alter weight distribution) - Inability to participate in moderate physical activity |
Country | Name | City | State |
---|---|---|---|
United States | Childrens National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's National Research Institute | NutritionQuest, University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Mental health | Mood and outlook will be assessed by self-report questionnaire: Patient Health Questionnaire for somatic symptoms, anxiety, and depression (PHQ-SADS) a continuous scale (0-86) with higher scores reflecting poorer mental health. | Change from Baseline level at 2 months | |
Primary | Change in plasma ceramides | S1P, C:14, and C:16 | Change from Baseline level of plasma ceramides at 2 months | |
Secondary | Change in plasma lipids | Plasma triglycerides, HDL-c, LDL-c | Change from Baseline level at 2 months | |
Secondary | Change in plasma glucose | Change from Baseline level at 2 months | ||
Secondary | Change in plasma insulin | Change from Baseline level at 2 months | ||
Secondary | Change in plasma C-reactive protein (CRP) | Change from Baseline level at 2 months | ||
Secondary | Change in waist circumference | Change from Baseline level at 2 months | ||
Secondary | Change in BMI | weight for height (Kg/M^2) | Change from Baseline level at 2 months | |
Secondary | Change in physical activity | Physical activity is assessed by self-report questionnaire. The activity questionnaire asks about frequency and duration of performance of a list of activities. | Change from Baseline level at 2 months | |
Secondary | Change in diet | Diet assessment by food frequency questionnaire (FFQ) to determine quantity and quality of macronutrients (carbs, protein, fat) and food groups (i.e. sugar sweetened beverages, fruits, vegetables, etc.) indexed as healthy eating score (Alternative Healthy Eating Index) on a scale of 2.5 to 87.5 with a higher score reflecting a more healthful diet. | Change from Baseline level at 2 months |
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