Obesity, ChildhoodPSMFNCT03899311
A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity (PSMF)
An observational study of Obesity, Childhood, run by Ihuoma Eneli at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 11 to 19 years
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- protein-sparing modified fast diet
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 28 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children and adolescents seen by Center for Healthy Weight and Nutrition at Nationwide Children's Hospital
Who may be able to join
- 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
Who cannot join
- non-English speaking
- Patients without adequate social/psychological capacity, as evidenced by unavailability to recourses, or family is unable to provide support.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity
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.
Read the detailed description
Aggressive dietary interventions may provide an accessible treatment option for children and adolescents with severe obesity who are not successful with traditional lifestyle behavioral interventions or do not want or qualify for weight loss surgery. One such intensive dietary option is the protein sparing modified fast (PSMF). The PSMF involves minimal carbohydrate intake to induce ketosis, while maintaining adequate or high protein intake to minimize catabolism. The PSMF, under medical supervision, can be an effective and safe intervention for children and adolescents, yet the PSMF diet is not regularly used in the treatment of pediatric severe obesity. This pilot study will employ a prospective cohort study design. Thirty children, 11-19 years-old, with severe obesity, who have been prescribed the rPSMF as part of their treatment in a tertiary care pediatric weight management clinic (PWMC), will be recruited along with their attending parent to participate in the study. The primary aim of the study is to evaluate the acceptability of the rPSMF as assessed by adherence, satisfaction with the intervention, and participation rate using quantitative and qualitative methods. The secondary aim is to investigate the effectiveness of the rPSMF on improving a) anthropometric measures (weight, body mass index [BMI] and BMI z-score); b) metabolic measures (lipid profile, glycosylated hemoglobin, liver function tests); and c) quality of life. Results of this study will provide guidance for the standardization of a pediatric rPSMF protocol in a clinic setting, delineate which factors improve or hinder adherence and weight loss and provide preliminary data for a multicenter randomized controlled trial.
- Conditions
- Obesity, Childhood
- Being tested
- protein-sparing modified fast diet
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein-sparing modified fast dietOther
Also called The PSMF diet
a PSMF diet follow the usual care format in the Center
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: protein-sparing modified fast diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
The acceptability of PSMF diet in a tertiary weight management clinic
Adherence to the diet tracked by clinical dietitian's notes
Measured: 12 months
Secondary outcomes (2)
Change of body weight between baseline and 12 months among subjects on PSMF
Body weight in kilograms
Measured: Baseline and 12 months
Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF
BMI in kg/m^2
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2019
- Study start1 Jan 2016
- Primary completion28 Feb 2019
- Study completion28 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ihuoma Eneli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ihuoma Eneli, Nationwide Children's Hospital
- Investigators
- Ihuoma Eneli, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03899311
- Sponsor's protocol ID
- IRB15-00667
- Acronym
- PSMF
- Status last verified
- Mar 2019
- First submitted
- 24 Jan 2018
- Last updated
- 2 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 31431932
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Protein-sparing Modified Fast for Children and Adolescents With Severe Obesity
- ClinicalTrials.gov ID
- NCT03899311
- Acronym / sponsor ID
- PSMF / IRB15-00667
- Conditions
- Obesity, Childhood
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ihuoma EneliUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 28 Feb 2019 (actual)
- First posted
- 2 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aggressive dietary interventions may provide an accessible treatment option for children and adolescents with severe obesity who are not successful with traditional lifestyle behavioral interventions or do not want or qualify for weight loss surgery. One such intensive dietary option is the protein sparing modified fast (PSMF). The PSMF involves minimal carbohydrate intake to induce ketosis, while maintaining adequate or high protein intake to minimize catabolism. The PSMF, under medical supervision, can be an effective and safe intervention for children and adolescents, yet the PSMF diet is not regularly used in the treatment of pediatric severe obesity. This pilot study will employ a prospective cohort study design. Thirty children, 11-19 years-old, with severe obesity, who have been prescribed the rPSMF as part of their treatment in a tertiary care pediatric weight management clinic (PWMC), will be recruited along with their attending parent to participate in the study. The primary aim of the study is to evaluate the acceptability of the rPSMF as assessed by adherence, satisfaction with the intervention, and participation rate using quantitative and qualitative methods. The secondary aim is to investigate the effectiveness of the rPSMF on improving a) anthropometric measures (weight, body mass index [BMI] and BMI z-score); b) metabolic measures (lipid profile, glycosylated hemoglobin, liver function tests); and c) quality of life. Results of this study will provide guidance for the standardization of a pediatric rPSMF protocol in a clinic setting, delineate which factors improve or hinder adherence and weight loss and provide preliminary data for a multicenter randomized controlled trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSMF cohort | – | Other: protein-sparing modified fast dietThe 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. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children and adolescents seen by Center for Healthy Weight and Nutrition at Nationwide Children's Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- non-English speaking
- Patients without adequate social/psychological capacity, as evidenced by unavailability to recourses, or family is unable to provide support.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| protein-sparing modified fast dietAlso: The PSMF dieta PSMF diet follow the usual care format in the Center | Other | PSMF cohort |
Primary outcome
The acceptability of PSMF diet in a tertiary weight management clinic
Time frame: Baseline
The percentage of patients and families recruited over all approached eligible patients, during the recruitment period
The acceptability of PSMF diet in a tertiary weight management clinic
Time frame: 12 months
Adherence to the diet tracked by clinical dietitian's notes
2 secondary outcomes
Change of body weight between baseline and 12 months among subjects on PSMF
Time frame: Baseline and 12 months
Change of Body Mass Index (BMI) between baseline and 12 months among subjects on PSMF
Time frame: Baseline and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2019.
- BackgroundWatowicz 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.
- Derived from this study: PubMed 31431932Eneli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihuoma Eneli, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood, run by Ihuoma Eneli at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The acceptability of PSMF diet in a tertiary weight management clinic (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03899311, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.