RECRUITING

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children

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Conditions

ObesityDiabetesCardiovascular Diseases

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will evaluate the effects of whole vs. nonfat milk consumption on body composition, cardiometabolic disease risk factors, and dietary quality.

Official Title

Effects of Whole vs. Nonfat Milk Consumption on Body Composition in Children: a 1-Year RCT

Quick Facts

Study Start:2022-12-28
Study Completion:2025-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05464186

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:9 Years to 12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Aged 9 to 12 years
  2. * BMI ≥75th percentile for sex and age
  3. * Residence in the Greater Boston catchment area
  1. * Aversion to nonfat or whole milk
  2. * Physician diagnosis of major medical illness, eating disorder, or milk allergy (lactose intolerance not exclusionary as lactase treated milk can be provided)
  3. * Abnormal laboratory tests: HgA1c, TSH, hematocrit, BUN, creatinine, ALT (\>1.5 normal upper limit)
  4. * Plans to move away from the Greater Boston catchment area during the study period
  5. * Plans to be away from home for ≥5 weeks during the study period (e.g., extended summer vacation)
  6. * Change in body weight exceeding 10% during prior year
  7. * Recent adherence to a special diet
  8. * Chronic use of any medication or dietary supplement that could affect study outcomes
  9. * Another member of the family (first degree relative) or household participating in the study

Contacts and Locations

Study Contact

Donna L Lesperance, MA, MPH
CONTACT
617-919-7305
Donna.Lesperance@childrens.harvard.edu

Principal Investigator

Cara B Ebbeling, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
David S Ludwig, MD, PhD
PRINCIPAL_INVESTIGATOR
Boston Children's Hospital

Study Locations (Sites)

New Balance Foundation Obesity Prevention Center
Boston, Massachusetts, 02115
United States

Collaborators and Investigators

Sponsor: Boston Children's Hospital

  • Cara B Ebbeling, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital
  • David S Ludwig, MD, PhD, PRINCIPAL_INVESTIGATOR, Boston Children's Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-28
Study Completion Date2025-10

Study Record Updates

Study Start Date2022-12-28
Study Completion Date2025-10

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Diabetes
  • Cardiovascular Diseases