A Multidisciplinary Intervention for Weight Loss

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04622982
• Other study ID #: 1206/151217
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: November 2020
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: September 30, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body composition - Body Fat Mass	Change in Body Fat	12 weeks
Other	Body composition - Body Fat free mass	change in Body Fat free mass	12 weeks
Other	Body composition - Visceral Fat mass	change in Visceral Fat mass	12 weeks
Other	Body Circumferences - arm	change in circumferences (arm)	12 weeks
Other	Body Circumferences - calf	change in circumferences (calf)	12 weeks
Other	Body Circumferences - waist	change in circumferences ( waist)	12 weeks
Other	Body Circumferences - hips	change in circumferences (hips)	12 weeks
Other	Iron	Change in blood Iron concentration	12 weeks
Other	Other biochemical parameters - vit D	Change in blood vitamin D	12 weeks
Other	Other biochemical parameters - vit B12	Change in blood vitamin B12	12 weeks
Other	Other biochemical parameters - Folates	Change in blood Folates	12 weeks
Other	Other biochemical parameters - transferrin	Change in transferrin	12 weeks
Other	Other biochemical parameters - Homocystein	Change in Homocystein	12 weeks
Other	Other biochemical parameters - albumin	Change in blood proteins (albumin)	12 weeks
Other	Other biochemical parameters - prealbumin	Change in blood proteins (prealbumin)	12 weeks
Other	Other biochemical parameters - enzymes - lipase	Change in blood enzymes (lipase)	12 weeks
Other	Other biochemical parameters - enzymes - amylase	Change in blood enzymes (amylase)	12 weeks
Other	Other biochemical parameters - thyroid hormones - FT3	Change in FT3	12 weeks
Other	Other biochemical parameters - thyroid hormones - FT4	Change in FT4	12 weeks
Other	Other biochemical parameters - thyroid hormones - TSH	Change in TSH	12 weeks
Other	Other biochemical parameters - inflammatory markers - CRP	Change in C-reactive protein	12 weeks
Other	Other biochemical parameters - inflammatory markers - ESR	Change in Erythrocyte Sedimentation Rate	12 weeks
Other	Other biochemical parameters - creatinin	Change in blood creatinin	12 weeks
Other	Uric acid	Change in uric acid blood concentration	12 weeks
Primary	Body Weight	Change in body Weight	12 weeks
Secondary	GlycaemIa	Change in glycaemia	12 weeks
Secondary	Insulin	Change in insulin blood levels	12 weeks
Secondary	Homa IR	Change in HOMA-IR	12 weeks
Secondary	Total cholesterol	Change in blood total cholesterol	12 weeks
Secondary	LDL cholesterol	Change in LDL cholesterol	12 weeks
Secondary	HDL cholesterol	Change in HDL cholesterol	12 weeks
Secondary	Triglycerides	Change in triglycerides	12 weeks
Secondary	AST (Aspartate Aminotransferase)	Change in blood of Aspartate Aminotransferase (AST)	12 weeks
Secondary	ALT (alanine aminotransferase)	Change in blood of alanine aminotransferase (ALT)	12 weeks
Secondary	GGT (gamma-glutamyl transpeptidase)	Change in blood of gamma-glutamyl transpeptidase (GGT)	12 weeks
Secondary	Total bilirubin	Change in blood total bilirubin	12 weeks
Secondary	Basal metabolic rate	Change in basal metabolic rate	12 weeks