Prospective Metabolic Indicator Study

NCT ID: NCT03588117

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 479 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-01
• Study Completion Date: 2017-06-30

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.

Conditions

Metabolic Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Physician-supervised nonsurgical weight management program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 83 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medi-Weightloss Franchising USA, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Macklin E. Guzmán

Chief Science Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 31840755 (View on PubMed)

Other Identifiers

MWLCT01

Identifier Type: -

Identifier Source: org_study_id