NCT02353637

Brief Summary

The aim of the study is to investigate, in severely obese adolescents, the effects of a high protein, restricted carbohydrates utilizing partial meal replacements diet (HPRC-PMR) on weight loss, body composition, and bio-chemical markers of lipid metabolism, insulin resistance, and inflammation over a 12 months period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2018

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

3.3 years

First QC Date

January 21, 2015

Last Update Submit

June 15, 2018

Conditions

Pediatric Obesity

Outcome Measures

Primary Outcomes (3)

  • Improvement in BMI-Z Scores

    BMI measurements will be taken at all appointments for 12 months to track improvement in BMI

    12 months

  • Weight Loss

    Weigh will be obtained at each appointment to track weight loss of 12 months

    12 months

  • Metabolic Abnormalities (Periodic labwork will be obtained over the 12 month period to monitor metabolic abnormalities)

    Periodic labwork will be obtained over the 12 month period to monitor metabolic abnormalities

    12 months

Study Arms (2)

Male High Protein, Restricted Carbo, Partial Meal Replacement

ACTIVE COMPARATOR

A high protein, restricted carbohydrates diet that utilizes partial meal replacements

Dietary Supplement: Partial Meal Replacements

Female High Protein, Restricted Carbo, Partial Meal Replaceme

ACTIVE COMPARATOR

A high protein, restricted carbohydrates diet that utilizes partial meal replacements

Dietary Supplement: Partial Meal Replacements

Interventions

Partial Meal ReplacementsDIETARY_SUPPLEMENT

The use of partial meal replacements will be utilized in conjunction with a high protein, restricted carbohydrate diet

Female High Protein, Restricted Carbo, Partial Meal ReplacemeMale High Protein, Restricted Carbo, Partial Meal Replacement

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Severely obese adolescents (13 to 17 year old males and post-menarcheal females between the ages of 12 and 17) will be recruited through the UF Health Pediatric Weight Management Center.
  • All patients would undergo a multifaceted assessment that is part of the standard of care at the UF Pediatric Weight Management Center. (This includes a behavioral assessment conducted by the Center's psychologist, a detailed medical history and physical examination as well as a comprehensive laboratory testing to investigate for obesity comorbidities as indicated clinically for the individual patient. These laboratory tests include but not limited to the following: CBC, comprehensive metabolic panel, liver enzymes, thyrotropin, fasting plasma glucose and insulin levels, fasting lipid profile and urinalysis.)
  • As part of the standard of care at the UF Pediatric Weight Management Center, patients and families complete the IWQOL (Obesity and Quality of Life) questionnaires as well as the UF Pediatric Weight Management Center Physical Activity questionnaire.
  • Adolescents with primary obesity and a BMI≥ 99th percentile for age.

You may not qualify if:

  • Current Diagnosis of Type II Diabetes Mellitis
  • Gall Bladder, Renal or Liver Disorders
  • Known Eating Disorders
  • Known Endocrine Disorders (such as hyperthyroidism or polycystic ovary syndrome)
  • Pregnancy
  • Genetic disorder (such as Prader-Willi Syndrome)
  • Mental Retardation
  • Severe Depression
  • Use of any chronic medicine which could impact appetite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Pediatric Weight Management Center

Jacksonville, Florida, 32207, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Madeline Joseph, MD

    UFJP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2015

First Posted

February 3, 2015

Study Start

November 1, 2014

Primary Completion

February 22, 2018

Study Completion

February 22, 2018

Last Updated

June 19, 2018

Record last verified: 2018-06

Locations

US(1)