Metabolic Optimization Through Diet/Lifestyle Improvements For Youth

NCT04270084 | Unknown

• 1 other identifier: Pro00010790
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dyslipidemias; Obesity

Keywords

cardiometabolic risk factors; lifestyle modification; visceral adiposity

Outcome Measures

Primary Outcomes (1)

• Change in plasma ceramides

  S1P, C:14, and C:16

  Change from Baseline level of plasma ceramides at 2 months

Secondary Outcomes (8)

• Change in plasma lipids

  Change from Baseline level at 2 months

• Change in plasma glucose

  Change from Baseline level at 2 months

• Change in plasma insulin

  Change from Baseline level at 2 months

• Change in plasma C-reactive protein (CRP)

  Change from Baseline level at 2 months

• Change in waist circumference

  Change from Baseline level at 2 months

Other Outcomes (1)

• Mental health

  Change from Baseline level at 2 months

Study Arms (1)

Treatment

OTHER

Participants will be asked use a mobile health (m-health) app for 2 months. The app is designed to provide weekly education and motivation about healthful diet and physical activity behaviors in adolescents and their parent/adult caretaker. Both adolescent and parent/adult caretaker participants will use the app to enter weekly self-report data, set healthy eating and exercise goals, and receive educational and motivational content. Participants will conduct a weekly self-assessment of waist circumference, diet, and physical activity during the 2 month trial.

Behavioral: Alive-Family

Interventions

Alive-Family BEHAVIORAL

All participants receive lifestyle modification through use of m-health app

Treatment

Eligibility Criteria

• Age: 10 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Parent or adult caregiver of adolescent patient Central adiposity (waist to height ratio \>0.5) Willingness to participate

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's National Research Institute: lead
• University of California, Davis: collaborator
• NutritionQuest: collaborator

Study Sites (1)

Childrens National Hospital

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Dyslipidemias; Obesity

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michele Mietus-Snyder, MD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 17, 2020
• Study Start: September 29, 2020
• Primary Completion: January 19, 2022
• Study Completion: December 31, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)