search
Back to results

A Multidisciplinary Intervention for Weight Loss

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)
Sponsored by
Azienda di Servizi alla Persona di Pavia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    All participants

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Body Weight
    Change in body Weight

    Secondary Outcome Measures

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

    Full Information

    First Posted
    October 31, 2020
    Last Updated
    November 5, 2020
    Sponsor
    Azienda di Servizi alla Persona di Pavia
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04622982
    Brief Title
    A Multidisciplinary Intervention for Weight Loss
    Official Title
    Efficacy and Safety of a Long-term Multidisciplinary Weight Loss Intervention in Patients With Obesity: an Open Label Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1, 2016 (Actual)
    Primary Completion Date
    October 31, 2019 (Actual)
    Study Completion Date
    September 30, 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Azienda di Servizi alla Persona di Pavia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Open Label study
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    151 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    All participants
    Arm Type
    Experimental
    Arm Description
    Obese subjects with BMI >= 30 and with one or more of metabolic comorbidities (type 2 diabetes mellitus, dyslipidemia, high blood pressure, hyperuricemia, and others).
    Intervention Type
    Other
    Intervention Name(s)
    Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Body Weight
    Description
    Change in body Weight
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    GlycaemIa
    Description
    Change in glycaemia
    Time Frame
    12 weeks
    Title
    Insulin
    Description
    Change in insulin blood levels
    Time Frame
    12 weeks
    Title
    Homa IR
    Description
    Change in HOMA-IR
    Time Frame
    12 weeks
    Title
    Total cholesterol
    Description
    Change in blood total cholesterol
    Time Frame
    12 weeks
    Title
    LDL cholesterol
    Description
    Change in LDL cholesterol
    Time Frame
    12 weeks
    Title
    HDL cholesterol
    Description
    Change in HDL cholesterol
    Time Frame
    12 weeks
    Title
    Triglycerides
    Description
    Change in triglycerides
    Time Frame
    12 weeks
    Title
    AST (Aspartate Aminotransferase)
    Description
    Change in blood of Aspartate Aminotransferase (AST)
    Time Frame
    12 weeks
    Title
    ALT (alanine aminotransferase)
    Description
    Change in blood of alanine aminotransferase (ALT)
    Time Frame
    12 weeks
    Title
    GGT (gamma-glutamyl transpeptidase)
    Description
    Change in blood of gamma-glutamyl transpeptidase (GGT)
    Time Frame
    12 weeks
    Title
    Total bilirubin
    Description
    Change in blood total bilirubin
    Time Frame
    12 weeks
    Title
    Basal metabolic rate
    Description
    Change in basal metabolic rate
    Time Frame
    12 weeks
    Other Pre-specified Outcome Measures:
    Title
    Body composition - Body Fat Mass
    Description
    Change in Body Fat
    Time Frame
    12 weeks
    Title
    Body composition - Body Fat free mass
    Description
    change in Body Fat free mass
    Time Frame
    12 weeks
    Title
    Body composition - Visceral Fat mass
    Description
    change in Visceral Fat mass
    Time Frame
    12 weeks
    Title
    Body Circumferences - arm
    Description
    change in circumferences (arm)
    Time Frame
    12 weeks
    Title
    Body Circumferences - calf
    Description
    change in circumferences (calf)
    Time Frame
    12 weeks
    Title
    Body Circumferences - waist
    Description
    change in circumferences ( waist)
    Time Frame
    12 weeks
    Title
    Body Circumferences - hips
    Description
    change in circumferences (hips)
    Time Frame
    12 weeks
    Title
    Iron
    Description
    Change in blood Iron concentration
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - vit D
    Description
    Change in blood vitamin D
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - vit B12
    Description
    Change in blood vitamin B12
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - Folates
    Description
    Change in blood Folates
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - transferrin
    Description
    Change in transferrin
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - Homocystein
    Description
    Change in Homocystein
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - albumin
    Description
    Change in blood proteins (albumin)
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - prealbumin
    Description
    Change in blood proteins (prealbumin)
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - enzymes - lipase
    Description
    Change in blood enzymes (lipase)
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - enzymes - amylase
    Description
    Change in blood enzymes (amylase)
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - thyroid hormones - FT3
    Description
    Change in FT3
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - thyroid hormones - FT4
    Description
    Change in FT4
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - thyroid hormones - TSH
    Description
    Change in TSH
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - inflammatory markers - CRP
    Description
    Change in C-reactive protein
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - inflammatory markers - ESR
    Description
    Change in Erythrocyte Sedimentation Rate
    Time Frame
    12 weeks
    Title
    Other biochemical parameters - creatinin
    Description
    Change in blood creatinin
    Time Frame
    12 weeks
    Title
    Uric acid
    Description
    Change in uric acid blood concentration
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mariangela Rondanelli, MD, PhD
    Organizational Affiliation
    Azienda di Servizi alla Persona di Pavia
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD are not shared. Published article will display mean baseline values and mean differences from baseline.

    Learn more about this trial

    A Multidisciplinary Intervention for Weight Loss

    We'll reach out to this number within 24 hrs