Clinical trial NCT03588117: Prospective Metabolic Indicator Study
Official title: Impact of Physician-supervised Nonsurgical Weight Management Program on Metabolic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metabolic Syndrome
Keywords: Metabolic Syndrome
Lead sponsor: Medi-Weightloss Franchising USA, LLC
Sponsor class: INDUSTRY
First posted: 2018-07-17
Enrollment: 479
Sex: ALL
Minimum age (years): 19
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: New patients of the Medi-Weightloss franchise, a physician-supervised nonsurgical weight management program

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence of metabolic syndrome at week 13
timeFrame: 13 weeks from first visit
measure: Prevalence of metabolic syndrome at week 26
timeFrame: 26 weeks from first visit
measure: Prevalence of metabolic syndrome at week 39
timeFrame: 39 weeks from first visit
measure: Prevalence of metabolic syndrome at week 52
timeFrame: 52 weeks from first visit
Secondary outcomes:
measure: Components of metabolic syndrome at week 13 - change in waist circumference (cm)
timeFrame: 13 weeks from first visit
measure: Components of metabolic syndrome at week 26 - change in waist circumference (cm)
timeFrame: 26 weeks from first visit
measure: Components of metabolic syndrome at week 39 - change in waist circumference (cm)
timeFrame: 39 weeks from first visit
measure: Components of metabolic syndrome at week 52 - change in waist circumference (cm)
timeFrame: 52 weeks from first visit
measure: Components of metabolic syndrome at week 13 - change in blood pressure (mmHg)
timeFrame: 13 weeks from first visit
measure: Components of metabolic syndrome at week 26 - change in blood pressure (mmHg)
timeFrame: 26 weeks from first visit
measure: Components of metabolic syndrome at week 39 - change in blood pressure (mmHg)
timeFrame: 39 weeks from first visit
measure: Components of metabolic syndrome at week 52 - change in blood pressure (mmHg)
timeFrame: 52 weeks from first visit
measure: Components of metabolic syndrome at week 13 - change in triglycerides (mmol/L)
timeFrame: 13 weeks from first visit
measure: Components of metabolic syndrome at week 26 - change in triglycerides (mmol/L)
timeFrame: 26 weeks from first visit
measure: Components of metabolic syndrome at week 39 - change in triglycerides (mmol/L)
timeFrame: 39 weeks from first visit
measure: Components of metabolic syndrome at week 52 - change in triglycerides (mmol/L)
timeFrame: 52 weeks from first visit
measure: Components of metabolic syndrome at week 13 - change in blood plasma glucose (mmol/L)
timeFrame: 13 weeks from first visit
measure: Components of metabolic syndrome at week 26 - change in blood plasma glucose (mmol/L)
timeFrame: 26 weeks from first visit
measure: Components of metabolic syndrome at week 39 - change in blood plasma glucose (mmol/L)
timeFrame: 39 weeks from first visit
measure: Components of metabolic syndrome at week 52 - change in blood plasma glucose (mmol/L)
timeFrame: 52 weeks from first visit
measure: Components of metabolic syndrome at week 13 - change in high density lipoproteins (HDL, mmol/L)
timeFrame: 13 weeks from first visit
measure: Components of metabolic syndrome at week 26 - change in high density lipoproteins (HDL, mmol/L)
timeFrame: 26 weeks from first visit
measure: Components of metabolic syndrome at week 39 - change in high density lipoproteins (HDL, mmol/L).
timeFrame: 39 weeks from first visit
measure: Components of metabolic syndrome at week 52 - change in high density lipoproteins (HDL, mmol/L).
timeFrame: 52 weeks from first visit
Other outcomes:
Locations:
Study officials:
References:
citation: 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.