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OpenTrials
Completed

NCT Number: NCT03588117

Prospective Metabolic Indicator Study

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.

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Key information

Conditions

Metabolic Syndrome Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

19 year–83 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physician-supervised nonsurgical weight management program

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. Components of metabolic syndrome at week 13 - change in waist circumference (cm)

    Time frame: 13 weeks from first visit

    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.

  2. Components of metabolic syndrome at week 26 - change in waist circumference (cm)

    Time frame: 26 weeks from first visit

    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.

  3. Components of metabolic syndrome at week 39 - change in waist circumference (cm)

    Time frame: 39 weeks from first visit

    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.

  4. Components of metabolic syndrome at week 52 - change in waist circumference (cm)

    Time frame: 52 weeks from first visit

    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.

  5. Components of metabolic syndrome at week 13 - change in blood pressure (mmHg)

    Time frame: 13 weeks from first visit

    Change in blood pressure between baseline and week 13. Both blood pressures (systolic and diastolic) were assessed during the study.

  6. Components of metabolic syndrome at week 26 - change in blood pressure (mmHg)

    Time frame: 26 weeks from first visit

    Change in blood pressure between baseline and week 26. Both blood pressures (systolic and diastolic) were assessed during the study.

  7. Components of metabolic syndrome at week 39 - change in blood pressure (mmHg)

    Time frame: 39 weeks from first visit

    Change in blood pressure between baseline and week 39. Both blood pressures (systolic and diastolic) were assessed during the study.

  8. Components of metabolic syndrome at week 52 - change in blood pressure (mmHg)

    Time frame: 52 weeks from first visit

    Change in blood pressure between baseline and week 52. Both blood pressures (systolic and diastolic) were assessed during the study.

  9. Components of metabolic syndrome at week 13 - change in triglycerides (mmol/L)

    Time frame: 13 weeks from first visit

    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.

  10. Components of metabolic syndrome at week 26 - change in triglycerides (mmol/L)

    Time frame: 26 weeks from first visit

    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.

  11. Components of metabolic syndrome at week 39 - change in triglycerides (mmol/L)

    Time frame: 39 weeks from first visit

    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.

  12. Components of metabolic syndrome at week 52 - change in triglycerides (mmol/L)

    Time frame: 52 weeks from first visit

    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.

  13. Components of metabolic syndrome at week 13 - change in blood plasma glucose (mmol/L)

    Time frame: 13 weeks from first visit

    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.

  14. Components of metabolic syndrome at week 26 - change in blood plasma glucose (mmol/L)

    Time frame: 26 weeks from first visit

    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.

  15. Components of metabolic syndrome at week 39 - change in blood plasma glucose (mmol/L)

    Time frame: 39 weeks from first visit

    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.

  16. Components of metabolic syndrome at week 52 - change in blood plasma glucose (mmol/L)

    Time frame: 52 weeks from first visit

    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.

  17. Components of metabolic syndrome at week 13 - change in high density lipoproteins (HDL, mmol/L)

    Time frame: 13 weeks from first visit

    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.

  18. Components of metabolic syndrome at week 26 - change in high density lipoproteins (HDL, mmol/L)

    Time frame: 26 weeks from first visit

    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.

  19. Components of metabolic syndrome at week 39 - change in high density lipoproteins (HDL, mmol/L).

    Time frame: 39 weeks from first visit

    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.

  20. Components of metabolic syndrome at week 52 - change in high density lipoproteins (HDL, mmol/L).

    Time frame: 52 weeks from first visit

    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.

Sponsors and collaborators

Lead sponsor

Medi-Weightloss Franchising USA, LLC

Industry

Registry information

Official study title

Impact of Physician-supervised Nonsurgical Weight Management Program on Metabolic Syndrome

Acronym: PROMIS

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 17, 2018
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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