Metabolic SyndromePROMISNCT03588117
Prospective Metabolic Indicator Study
An observational study of Metabolic Syndrome, run by Medi-Weightloss Franchising USA, LLC.
Trial summary
The aim of this study was to assess the impact of a physician-supervised non-surgical medical weight management program on prevalence of metabolic syndrome and to examine the relationship between program retention and levels of key indicators of metabolic syndrome among participants that self-enrolled to the program. Read more about this study
- Who is it for?
- Ages 19 to 83 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Physician-supervised nonsurgical weight management program
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 479 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 30 Jun 2017
- 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 19 to 83 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: New patients of the Medi-Weightloss franchise, a physician-supervised nonsurgical weight management program
Who may be able to join
- The patient is at least 18 years of age.
- The patient is overweight or obese (BMI≥25 kg/m2).
Who cannot join
- The patient was previously enrolled in the Medi-Weightloss program
About this study
Official title: Impact of Physician-supervised Nonsurgical Weight Management Program on Metabolic Syndrome
The aim of this study was to assess the impact of a physician-supervised non-surgical medical weight management program on prevalence of metabolic syndrome and to examine the relationship between program retention and levels of key indicators of metabolic syndrome among participants that self-enrolled to the program. A total of 479 overweight or obese participants aged 19 years or older were observed. The revised National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria were used to define metabolic syndrome.
Read the detailed description
Each individual self-enrolled to a physician-supervised non-surgical weight management program, hereafter referred to as the Program. They received a weight loss intervention as a part of routine medical care in the Program. At the end of their first consultation, each individual that met the inclusion criteria and failed to meet the exclusion criteria was asked if he or she would like to join the study. Each individual was informed that the study would not change the type or level of care that he or she would receive while enrolled to the program; however, researchers would be studying the effects of their care through additional screenings. Individuals who thereafter signed an informed consent form were monitored for changes in health outcomes without change to the Program.
This study was observational. Health outcomes were assessed in individuals that predefined their program status (i.e., enrolled or not enrolled). Each participant received routine medical care, and the investigators studied the effects of the intervention. No new intervention or intervention specific to participants only was assigned.
- Conditions
- Metabolic Syndrome
- Being tested
- Physician-supervised nonsurgical weight management program
- Keywords
- Metabolic Syndrome
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physician-supervised nonsurgical weight management programBehavioural
Participants of a physician-supervised nonsurgical weight management program were observed as they received weekly in-person coaching sessions with licensed clinicians. In-person coaching sessions were focused on educating participants on strategies to manage their weight and adopt a healthy lifestyle. Prescribed diets were individualized based on each participant's behavior, level of physical activity, and total energy expenditure. Supplements, appetite suppressant medications, and compounded injections were used to control appetite and/or boost energy during a period of low-caloric intake. The program was generally divided into three phases: Acute, Short-Term Maintenance, and Wellness.
| Study group | Role | What they receive |
|---|---|---|
| Participants of a weight management program | Participants of a physician-supervised nonsurgical weight management program were observed as they received weekly in-person coaching sessions with licensed clinicians. In-person coaching sessions were focused on educating participants on strategies to manage their weight and adopt a healthy lifestyle. Prescribed diets were individualized based on each participant's behavior, level of physical activity, and total energy expenditure. Supplements, appetite suppressant medications, and compounded injections were used to control appetite and/or boost energy during a period of low-caloric intake. The program was generally divided into three phases: Acute, Short-Term Maintenance, and Wellness. Receives: Behavioral: Physician-supervised nonsurgical weight management program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of metabolic syndrome at week 13
Change in prevalence of metabolic syndrome from baseline at week 13
Measured: 13 weeks from first visit
Prevalence of metabolic syndrome at week 26
Change in prevalence of metabolic syndrome from baseline at week 26
Measured: 26 weeks from first visit
Prevalence of metabolic syndrome at week 39
Change in prevalence of metabolic syndrome from baseline at week 39
Measured: 39 weeks from first visit
Prevalence of metabolic syndrome at week 52
Change in prevalence of metabolic syndrome from baseline at week 52
Measured: 52 weeks from first visit
Secondary outcomes (20)
Components of metabolic syndrome at week 13 - change in waist circumference (cm)
Baseline waist circumference data were compared with week 13 waist circumference data. Waist circumference was measured at the narrowest point of hip area or the midpoint between the lower costal (10th rib) border and the iliac crest (upper hip bone). Waist circumference data were collected in inches, and converted to cm according to the journal's requirements.
Measured: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in waist circumference (cm)
Baseline waist circumference data were compared with week 26 waist circumference data. Waist circumference was measured at the narrowest point of hip area or the midpoint between the lower costal (10th rib) border and the iliac crest (upper hip bone). Waist circumference data were collected in inches, and converted to cm according to the journal's requirements.
Measured: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in waist circumference (cm)
Baseline waist circumference data were compared with week 39 waist circumference data. Waist circumference was measured at the narrowest point of hip area or the midpoint between the lower costal (10th rib) border and the iliac crest (upper hip bone). Waist circumference data were collected in inches, and converted to cm according to the journal's requirements.
Measured: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in waist circumference (cm)
Baseline waist circumference data were compared with week 52 waist circumference data. Waist circumference was measured at the narrowest point of hip area or the midpoint between the lower costal (10th rib) border and the iliac crest (upper hip bone). Waist circumference data were collected in inches, and converted to cm according to the journal's requirements.
Measured: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in blood pressure (mmHg)
Change in blood pressure between baseline and week 13. Both blood pressures (systolic and diastolic) were assessed during the study.
Measured: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in blood pressure (mmHg)
Change in blood pressure between baseline and week 26. Both blood pressures (systolic and diastolic) were assessed during the study.
Measured: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in blood pressure (mmHg)
Change in blood pressure between baseline and week 39. Both blood pressures (systolic and diastolic) were assessed during the study.
Measured: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in blood pressure (mmHg)
Change in blood pressure between baseline and week 52. Both blood pressures (systolic and diastolic) were assessed during the study.
Measured: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in triglycerides (mmol/L)
Baseline triglycerides data were compared with week 13 triglycerides data. Mean change from baseline was measured.Triglycerides data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in triglycerides (mmol/L)
Baseline triglycerides data were compared with week 26 triglycerides data. Mean change from baseline was measured.Triglycerides data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in triglycerides (mmol/L)
Baseline triglycerides data were compared with week 39 triglycerides data. Mean change from baseline was measured.Triglycerides data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in triglycerides (mmol/L)
Baseline triglycerides data were compared with week 52 triglycerides data. Mean change from baseline was measured.Triglycerides data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in blood plasma glucose (mmol/L)
Baseline blood plasma glucose data were compared with week 13 blood plasma glucose data. Mean change from baseline was measured. Blood plasma glucose data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in blood plasma glucose (mmol/L)
Baseline blood plasma glucose data were compared with week 26 blood plasma glucose data. Mean change from baseline was measured.Blood plasma glucose data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in blood plasma glucose (mmol/L)
Baseline blood plasma glucose data were compared with week 39 blood plasma glucose data. Mean change from baseline was measured.Blood plasma glucose data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in blood plasma glucose (mmol/L)
Baseline blood plasma glucose data were compared with week 52 blood plasma glucose data. Mean change from baseline was measured.Blood plasma glucose data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in high density lipoproteins (HDL, mmol/L)
Baseline HDL data were compared with week 13 HDL data. Mean change from baseline was measured.HDL data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in high density lipoproteins (HDL, mmol/L)
Baseline HDL data were compared with week 26 HDL data. Mean change from baseline was measured.HDL data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in high density lipoproteins (HDL, mmol/L).
Baseline HDL data were compared with week 39 HDL data. Mean change from baseline was measured.HDL data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in high density lipoproteins (HDL, mmol/L).
Baseline HDL data were compared with week 52 HDL data. Mean change from baseline was measured.HDL data were collected in mg/dl units, and converted to mmol/L according to the journal's requirements.
Measured: 52 weeks from first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Mar 2015
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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
- 479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medi-Weightloss Franchising USA, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Macklin E. Guzmán, Medi-Weightloss Franchising USA, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03588117
- Sponsor's protocol ID
- MWLCT01
- Acronym
- PROMIS
- Status last verified
- Jul 2018
- First submitted
- 10 May 2018
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Guzman M, Zbella E, Alvarez SS, Nguyen JL, Imperial E, Troncale FJ, Holub C, Mallhi AK, VanWyk S. Effect of an intensive lifestyle intervention on the prevalence of metabolic syndrome and its components among overweight and obese adults. J Public Health (Oxf). 2020 Nov 23;42(4):828-838. doi: 10.1093/pubmed/fdz170.
PubMed 31840755
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Physician-supervised Nonsurgical Weight Management Program on Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03588117
- Acronym / sponsor ID
- PROMIS / MWLCT01
- Conditions
- Metabolic Syndrome
- Keywords
- Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 479 participants (actual)
- Lead sponsor
- Medi-Weightloss Franchising USA, LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 17 Jul 2018 (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.
The aim of this study was to assess the impact of a physician-supervised non-surgical medical weight management program on prevalence of metabolic syndrome and to examine the relationship between program retention and levels of key indicators of metabolic syndrome among participants that self-enrolled to the program. A total of 479 overweight or obese participants aged 19 years or older were observed. The revised National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) criteria were used to define metabolic syndrome.
Detailed description
Each individual self-enrolled to a physician-supervised non-surgical weight management program, hereafter referred to as the Program. They received a weight loss intervention as a part of routine medical care in the Program. At the end of their first consultation, each individual that met the inclusion criteria and failed to meet the exclusion criteria was asked if he or she would like to join the study. Each individual was informed that the study would not change the type or level of care that he or she would receive while enrolled to the program; however, researchers would be studying the effects of their care through additional screenings. Individuals who thereafter signed an informed consent form were monitored for changes in health outcomes without change to the Program.
This study was observational. Health outcomes were assessed in individuals that predefined their program status (i.e., enrolled or not enrolled). Each participant received routine medical care, and the investigators studied the effects of the intervention. No new intervention or intervention specific to participants only was assigned.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants of a weight management program | – | Behavioral: Physician-supervised nonsurgical weight management programParticipants of a physician-supervised nonsurgical weight management program were observed as they received weekly in-person coaching sessions with licensed clinicians. In-person coaching sessions were focused on educating participants on strategies to manage their weight and adopt a healthy lifestyle. Prescribed diets were individualized based on each participant's behavior, level of physical activity, and total energy expenditure. Supplements, appetite suppressant medications, and compounded injections were used to control appetite and/or boost energy during a period of low-caloric intake. The program was generally divided into three phases: Acute, Short-Term Maintenance, and Wellness. |
Who may qualify
- Ages
- 19 to 83 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- New patients of the Medi-Weightloss franchise, a physician-supervised nonsurgical weight management program
Key inclusion criteria (2 listed)
- The patient is at least 18 years of age.
- The patient is overweight or obese (BMI≥25 kg/m2).
Key exclusion criteria (1 listed)
- The patient was previously enrolled in the Medi-Weightloss program
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 |
|---|---|---|
| Physician-supervised nonsurgical weight management programParticipants of a physician-supervised nonsurgical weight management program were observed as they received weekly in-person coaching sessions with licensed clinicians. In-person coaching sessions were focused on educating participants on strategies to manage their weight and adopt a healthy lifestyle. Prescribed diets were individualized based on each participant's behavior, level of physical activity, and total energy expenditure. Supplements, appetite suppressant medications, and compounded injections were used to control appetite and/or boost energy during a period of low-caloric intake. The program was generally divided into three phases: Acute, Short-Term Maintenance, and Wellness. | Behavioural | Participants of a weight management program |
Primary outcome
Prevalence of metabolic syndrome at week 13
Time frame: 13 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 13
Prevalence of metabolic syndrome at week 26
Time frame: 26 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 26
Prevalence of metabolic syndrome at week 39
Time frame: 39 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 39
Prevalence of metabolic syndrome at week 52
Time frame: 52 weeks from first visit
Change in prevalence of metabolic syndrome from baseline at week 52
20 secondary outcomes
Components of metabolic syndrome at week 13 - change in waist circumference (cm)
Time frame: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in waist circumference (cm)
Time frame: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in waist circumference (cm)
Time frame: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in waist circumference (cm)
Time frame: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in blood pressure (mmHg)
Time frame: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in blood pressure (mmHg)
Time frame: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in blood pressure (mmHg)
Time frame: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in blood pressure (mmHg)
Time frame: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in triglycerides (mmol/L)
Time frame: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in triglycerides (mmol/L)
Time frame: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in triglycerides (mmol/L)
Time frame: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in triglycerides (mmol/L)
Time frame: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in blood plasma glucose (mmol/L)
Time frame: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in blood plasma glucose (mmol/L)
Time frame: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in blood plasma glucose (mmol/L)
Time frame: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in blood plasma glucose (mmol/L)
Time frame: 52 weeks from first visit
Components of metabolic syndrome at week 13 - change in high density lipoproteins (HDL, mmol/L)
Time frame: 13 weeks from first visit
Components of metabolic syndrome at week 26 - change in high density lipoproteins (HDL, mmol/L)
Time frame: 26 weeks from first visit
Components of metabolic syndrome at week 39 - change in high density lipoproteins (HDL, mmol/L).
Time frame: 39 weeks from first visit
Components of metabolic syndrome at week 52 - change in high density lipoproteins (HDL, mmol/L).
Time frame: 52 weeks from first visit
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 17 Jul 2018.
- Derived from this study: PubMed 31840755Guzman M, Zbella E, Alvarez SS, Nguyen JL, Imperial E, Troncale FJ, Holub C, Mallhi AK, VanWyk S. Effect of an intensive lifestyle intervention on the prevalence of metabolic syndrome and its components among overweight and obese adults. J Public Health (Oxf). 2020 Nov 23;42(4):828-838. doi: 10.1093/pubmed/fdz170.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by Medi-Weightloss Franchising USA, LLC.
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 2 inclusion and 1 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Prevalence of metabolic syndrome at week 13 (time frame: 13 weeks from first visit). The study lists 4 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 NCT03588117, which also lists 1 linked publication.
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 17 Jul 2018.