A Multidisciplinary Intervention for Weight Loss

Efficacy and Safety of a Long-term Multidisciplinary Weight Loss Intervention in Patients With Obesity: an Open Label Study

This is an open label study in which obese participants were treated with a restrictive hypo-caloric diet under hospitalization for a maximum period of 3 months in a metabolic rehabilitation unit. A multidisciplinary approach was used (combination of diet, physical exercise and psychotherapy)

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Other: Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age >= 18
• BMI >= 30
• one or more comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others)

Exclusion Criteria:

• active cancer
• severe cognitive or functional impairments
• severe behavioral disorders
• known kidney failure (previous glomerular filtration rate <30 ml/min)
• known liver failure (Child B or C)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: All participants; Obese subjects with BMI >= 30 and with one or more of metabolic comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others).

Other: Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy); Body weight reduction was induced by a low-energy mixed diet (55 % carbohydrates, 30 % lipids and 15 % proteins) providing 600 kcal less than individually estimated energy requirements based on the measured REE. The energy content and macronutrient composition of the diets adhered to the nutritional recommendations of the American Diabetes Association. Patients were administered vitamin D supplement only if they presented a value of 25-hydroxyvitamin D (25OHD) <30 ng/ml in blood tests at the beginning. Patients were following an individualized physical activity plan within the hospital and were aided by a psychodynamic approach therapist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Weight	Change in body Weight	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GlycaemIa	Change in glycaemia	12 weeks
Insulin	Change in insulin blood levels	12 weeks
Homa IR	Change in HOMA-IR	12 weeks
Total cholesterol	Change in blood total cholesterol	12 weeks
LDL cholesterol	Change in LDL cholesterol	12 weeks
HDL cholesterol	Change in HDL cholesterol	12 weeks
Triglycerides	Change in triglycerides	12 weeks
AST (Aspartate Aminotransferase)	Change in blood of Aspartate Aminotransferase (AST)	12 weeks
ALT (alanine aminotransferase)	Change in blood of alanine aminotransferase (ALT)	12 weeks
GGT (gamma-glutamyl transpeptidase)	Change in blood of gamma-glutamyl transpeptidase (GGT)	12 weeks
Total bilirubin	Change in blood total bilirubin	12 weeks
Basal metabolic rate	Change in basal metabolic rate	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition - Body Fat Mass	Change in Body Fat	12 weeks
Body composition - Body Fat free mass	change in Body Fat free mass	12 weeks
Body composition - Visceral Fat mass	change in Visceral Fat mass	12 weeks
Body Circumferences - arm	change in circumferences (arm)	12 weeks
Body Circumferences - calf	change in circumferences (calf)	12 weeks
Body Circumferences - waist	change in circumferences ( waist)	12 weeks
Body Circumferences - hips	change in circumferences (hips)	12 weeks
Iron	Change in blood Iron concentration	12 weeks
Other biochemical parameters - vit D	Change in blood vitamin D	12 weeks
Other biochemical parameters - vit B12	Change in blood vitamin B12	12 weeks
Other biochemical parameters - Folates	Change in blood Folates	12 weeks
Other biochemical parameters - transferrin	Change in transferrin	12 weeks
Other biochemical parameters - Homocystein	Change in Homocystein	12 weeks
Other biochemical parameters - albumin	Change in blood proteins (albumin)	12 weeks
Other biochemical parameters - prealbumin	Change in blood proteins (prealbumin)	12 weeks
Other biochemical parameters - enzymes - lipase	Change in blood enzymes (lipase)	12 weeks
Other biochemical parameters - enzymes - amylase	Change in blood enzymes (amylase)	12 weeks
Other biochemical parameters - thyroid hormones - FT3	Change in FT3	12 weeks
Other biochemical parameters - thyroid hormones - FT4	Change in FT4	12 weeks
Other biochemical parameters - thyroid hormones - TSH	Change in TSH	12 weeks
Other biochemical parameters - inflammatory markers - CRP	Change in C-reactive protein	12 weeks
Other biochemical parameters - inflammatory markers - ESR	Change in Erythrocyte Sedimentation Rate	12 weeks
Other biochemical parameters - creatinin	Change in blood creatinin	12 weeks
Uric acid	Change in uric acid blood concentration	12 weeks

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia
• Investigators: Study Director: Mariangela Rondanelli, MD, PhD, Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): September 30, 2020

Study Registration Dates

• First Submitted: October 31, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 10, 2020

Study Record Updates

• Last Update Posted (Actual): November 10, 2020
• Last Update Submitted That Met QC Criteria: November 5, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Body Weight Changes; Obesity; Weight Loss; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: 1206/151217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD are not shared. Published article will display mean baseline values and mean differences from baseline.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No