Prospective Metabolic Indicator Study (PROMIS)

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Behavioral: Physician-supervised nonsurgical weight management program

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 Type: Observational
• Enrollment (Actual): 479

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

New patients of the Medi-Weightloss franchise, a physician-supervised nonsurgical weight management program

Description

Inclusion Criteria:

• The patient is at least 18 years of age.
• The patient is overweight or obese (BMI≥25 kg/m2).

Exclusion Criteria:

- The patient was previously enrolled in the Medi-Weightloss program

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Behavioral: Physician-supervised nonsurgical 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of metabolic syndrome at week 13	Change in prevalence of metabolic syndrome from baseline at week 13	13 weeks from first visit
Prevalence of metabolic syndrome at week 26	Change in prevalence of metabolic syndrome from baseline at week 26	26 weeks from first visit
Prevalence of metabolic syndrome at week 39	Change in prevalence of metabolic syndrome from baseline at week 39	39 weeks from first visit
Prevalence of metabolic syndrome at week 52	Change in prevalence of metabolic syndrome from baseline at week 52	52 weeks from first visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	52 weeks from first visit

Collaborators and Investigators

• Sponsor: Medi-Weightloss Franchising USA, LLC

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2015
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: July 3, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 3, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Metabolic Syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: MWLCT01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No