Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.
Primary Purpose
Lifestyle Intervention
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
lifestyle intervention
Sponsored by
About this trial
This is an interventional treatment trial for Lifestyle Intervention
Eligibility Criteria
Inclusion Criteria:
- Subjects aged 45-64 from 6 family physicians, representative of the local Health Districts of Asti (Northern Italy)
- Presence of the metabolic syndrome (MS) or hs-CRP>3mg/l and 2 components of the MS
Exclusion Criteria:
- diabetes, cardiovascular diseases, chronic liver or kidney disease, advanced cancer
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention arm
control arm
Arm Description
lifestyle intervention program carried out by trained professionals
standard, unstructured information given by the family physicians
Outcomes
Primary Outcome Measures
Between-group change in the prevalence of the metabolic syndrome, defined by the National Cholesterol Education Program criteria
Metabolic syndrome was defined by the National Cholesterol Education Program criteria as the presence of ≥3 of the following five criteria: fasting glucose ≥6.1 mmol/L; blood pressure ≥ 130/85 mmHg; triglycerides ≥1.69 mmol/L; high-density lipoprotein (HDL) cholesterol <1.29 mmol/L (females) or <1.04 mmol/L (males), and waist circumference >88 cm (females) or >102 cm (males).
Secondary Outcome Measures
Within- and between-group variations in arterial blood pressure
Within- and between-group variations in weight values
Within- and between-group variations in fasting glucose
Within- and between-group variations in C-reactive protein values
Within- and between-group variations in triglyceride values
Within- and between-group variations in HDL-cholesterol values
Full Information
NCT ID
NCT03416439
First Posted
January 22, 2018
Last Updated
January 29, 2018
Sponsor
University of Turin, Italy
1. Study Identification
Unique Protocol Identification Number
NCT03416439
Brief Title
Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.
Official Title
Effectiveness of a Lifestyle Intervention on Metabolic Syndrome. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2004 (Actual)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
February 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Turin, Italy
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
The investigators compared the effectiveness of a lifestyle intervention program carried out by trained professionals versus standard unstructured information on healthy lifestyle given by the family physicians in ameliorating the metabolic pattern of adults with multiple metabolic and inflammatory abnormalities.
Detailed Description
Intensive lifestyle intervention significantly reduces the progression to diabetes in high-risk individuals. It is unknown if a less intensive program might also be effective in the general population.
The investigators' aim was to compare the effectiveness of two different modalities that recommend a healthier lifestyle to reduce multiple metabolic abnormalities-a lifestyle intervention program with general recommendations carried out by trained professionals and standard unstructured information given by the family physician-in a dysmetabolic population-based cohort.
All subjects aged 45-64 (n=1,877) from 6 family physicians, representative of the local Health Districts of Asti (Northern Italy), were contacted. A metabolic screening was carried out on 1,658 subjects (88.3%) who accepted to participate.
Out of those subjects, 375 patients had either the metabolic syndrome (MS) or two components of the MS plus high-sensitivity C-reactive protein (CRP) serum values ≥3 mg/L, the cutoff point that differentiates high-risk groups for future cardiovascular events, and did not have any of the exclusion criteria.
Then,187 were randomly allocated to the intervention arm and 188 to the control arm; 18 and 22 individuals refused to participate, respectively. Finally, 169 patients were assigned to the lifestyle intervention program carried out by trained professionals (intervention arm) and 166 to the standard, unstructured information given by the family physicians (control arm). All participants received verbal, not-written, information, emphasizing the importance of a healthy lifestyle from their family physicians, who had previously participated in 3 meetings on standard practice lifestyle recommendations. No further individualized programs were offered to the control arm.
The intervention arm received detailed verbal and written individualized diet and exercise recommendations from trained professionals during five 60-min sessions covering diet, exercise, and behavior modifications (the first was a one-to-one meeting, the following were group sessions).
Anthropometric measurements and blood samples were collected from all participants at the beginning and at the trial end, after 1-year.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lifestyle Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Lifestyle intervention program carried out by trained professionals versus standard, unstructured information given by the family physicians
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
335 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention arm
Arm Type
Experimental
Arm Description
lifestyle intervention program carried out by trained professionals
Arm Title
control arm
Arm Type
No Intervention
Arm Description
standard, unstructured information given by the family physicians
Intervention Type
Other
Intervention Name(s)
lifestyle intervention
Intervention Description
lifestyle intervention program carried out by trained professionals
Primary Outcome Measure Information:
Title
Between-group change in the prevalence of the metabolic syndrome, defined by the National Cholesterol Education Program criteria
Description
Metabolic syndrome was defined by the National Cholesterol Education Program criteria as the presence of ≥3 of the following five criteria: fasting glucose ≥6.1 mmol/L; blood pressure ≥ 130/85 mmHg; triglycerides ≥1.69 mmol/L; high-density lipoprotein (HDL) cholesterol <1.29 mmol/L (females) or <1.04 mmol/L (males), and waist circumference >88 cm (females) or >102 cm (males).
Time Frame
1 year after randomization
Secondary Outcome Measure Information:
Title
Within- and between-group variations in arterial blood pressure
Time Frame
1 year after randomization
Title
Within- and between-group variations in weight values
Time Frame
1 year after randomization
Title
Within- and between-group variations in fasting glucose
Time Frame
1-year after randomization
Title
Within- and between-group variations in C-reactive protein values
Time Frame
1-year after randomization
Title
Within- and between-group variations in triglyceride values
Time Frame
1-year after randomization
Title
Within- and between-group variations in HDL-cholesterol values
Time Frame
1-year after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects aged 45-64 from 6 family physicians, representative of the local Health Districts of Asti (Northern Italy)
Presence of the metabolic syndrome (MS) or hs-CRP>3mg/l and 2 components of the MS
Exclusion Criteria:
diabetes, cardiovascular diseases, chronic liver or kidney disease, advanced cancer
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of a Lifestyle Intervention on Metabolic Syndrome.
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