NCT03899311

Brief Summary

This is a 12 month prospective observational cohort study of the outpatient protein-sparing modified fast diet for children with severe obesity and serious comorbid condition(s). The study will enroll 30 Center for Healthy Weight and Nutrition patients aged 11-19 years who have been placed on a protein sparing modified fast as part of their treatment plan. The study-specific procedures consist of questionnaires/interviews on diet and PA behaviors, adherence and self-efficacy measures, data abstraction from the chart and tracking of activity using a Fitbit.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

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

January 1, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
Last Updated

April 2, 2019

Status Verified

March 1, 2019

Enrollment Period

3.2 years

First QC Date

January 24, 2018

Last Update Submit

March 31, 2019

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

  • The acceptability of PSMF diet in a tertiary weight management clinic

    The percentage of patients and families recruited over all approached eligible patients, during the recruitment period

    Baseline

  • The acceptability of PSMF diet in a tertiary weight management clinic

    Adherence to the diet tracked by clinical dietitian's notes

    12 months

Secondary Outcomes (2)

  • Change of body weight between baseline and 12 months among subjects on PSMF

    Baseline and 12 months

  • Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF

    Baseline and 12 months

Study Arms (1)

PSMF cohort

The cohort is instructed to follow a protein-sparing modified fast diet and is given standard health care in the Center for Healthy Weight and Nutrition at Nationwide Children's Hospital.

Other: protein-sparing modified fast diet

Interventions

protein-sparing modified fast dietOTHER

a PSMF diet follow the usual care format in the Center

Also known as: The PSMF diet
PSMF cohort

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents seen by Center for Healthy Weight and Nutrition at Nationwide Children's Hospital

You may qualify if:

  • Children Age 11-19 years old
  • Must be severely obese (BMI greater than or equal to 120% of the 95th percentile for their age and sex, or a BMI of 35 or greater)
  • Must have at least one severe comorbidity
  • Tanner Stage III, IV, V

You may not qualify if:

  • non-English speaking
  • Patients without adequate social/psychological capacity, as evidenced by unavailability to recourses, or family is unable to provide support.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (2)

  • Watowicz RP, Tindall AL, Hummel JC, Eneli IU. The Protein-Sparing Modified Fast for Adolescents With Severe Obesity. Childhood Obesity and Nutrition 7(5): 233-241, 2015.

    BACKGROUND

  • Eneli IU, Watowicz RP, Xu J, Tindall A, Walston M, Tanner K, Worthington J, Pratt KJ. Rationale and design of a pilot study to evaluate the acceptability and effectiveness of a revised protein sparing modified fast (rPSMF) for severe obesity in a pediatric tertiary care weight management clinic. Contemp Clin Trials Commun. 2019 May 27;15:100388. doi: 10.1016/j.conctc.2019.100388. eCollection 2019 Sep.

    PMID: 31431932DERIVED

Related Links

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ihuoma Eneli, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Center for Healthy Weight and Nutrition

Study Record Dates

First Submitted

January 24, 2018

First Posted

April 2, 2019

Study Start

January 1, 2016

Primary Completion

February 28, 2019

Study Completion

February 28, 2019

Last Updated

April 2, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)