Prospective Metabolic Indicator Study (PROMIS)

Medi-Weightloss Franchising

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Behavioral: Physician-supervised nonsurgical weight management program

Study type: Observational

Funder types: Industry

Identifiers

NCT03588117

MWLCT01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 479 patients

Sex: All

Ages: 19 to 83 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

479 participants in 1 patient group

Participants of a weight management program

Description:

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.

Treatment:

Behavioral: Physician-supervised nonsurgical weight management program