Prospective Metabolic Indicator Study

NCT03588117 | Completed

• 1 other identifier: MWLCT01
• Study Type: observational
• Target: 479
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolic Syndrome

Keywords

Metabolic Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (20)

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

  13 weeks from first visit

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

  26 weeks from first visit

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

  39 weeks from first visit

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

  52 weeks from first visit

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

  13 weeks from first visit

Study Arms (1)

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

Interventions

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.

Participants of a weight management program

Eligibility Criteria

• Age: 19 Years - 83 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medi-Weightloss Franchising USA, LLC: lead

Related Publications (1)

• 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.

  PMID: 31840755 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Science Officer

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: July 17, 2018
• Study Start: March 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07