A Multidisciplinary Intervention for Weight Loss

NCT04622982 | Completed

• 1 other identifier: 1206/151217
• Study Type: interventional
• Target: 151
• Locations: 0 countries
• Sites: N/A

Brief 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)

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Body Weight

  Change in body Weight

  12 weeks

Secondary Outcomes (12)

• GlycaemIa

  12 weeks

• Insulin

  12 weeks

• Homa IR

  12 weeks

• Total cholesterol

  12 weeks

• LDL cholesterol

  12 weeks

Other Outcomes (24)

• Body composition - Body Fat Mass

  12 weeks

• Body composition - Body Fat free mass

  12 weeks

• Body composition - Visceral Fat mass

  12 weeks

Study Arms (1)

All participants

EXPERIMENTAL

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)

Interventions

Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy) OTHER

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.

All participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Azienda di Servizi alla Persona di Pavia: lead

MeSH Terms

Conditions

Obesity

Interventions

Diet; Vitamin D; Exercise; Psychotherapy

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Behavioral Disciplines and Activities

Study Officials

• Mariangela Rondanelli, MD, PhD

  Azienda di Servizi alla Persona di Pavia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Label study

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 10, 2020
• Study Start: February 1, 2016
• Primary Completion: October 31, 2019
• Study Completion: September 30, 2020
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share