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
About this trial
This is an interventional treatment trial for Obesity
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)
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
NCT ID
NCT04622982
First Posted
October 31, 2020
Last Updated
November 5, 2020
Sponsor
Azienda di Servizi alla Persona di Pavia
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
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