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Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet

Primary Purpose

Obesity, Overweight

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Counseling Monthly Phone Calls
Self Help Informative Booklet
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, counselling, weight loss

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Female and male
  • BMI >25 and <35
  • Ages Eligible for Study: 18 years old to 75 years old
  • Patients of the Institute Orthopedic Rizzoli subject to personalized nutritional program admitted to the wards and patients attending the clinic of Anaesthesiology, analgesic therapy, Rheumatology
  • participants gave informed consent

Exclusion Criteria:

  • Patients with psychiatric disorders (depression, bulimia, anorexia
  • Concomitant use of medicines or food supplements that can alter the weight loss.
  • Patients with inclusion criteria that have not signed the informative report and the declaration of consent.

Sites / Locations

  • Istituto Ortopedico Rizzoli

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

counseling monthly phone calls

self help informative Booklet

Arm Description

the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.

Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.

Outcomes

Primary Outcome Measures

Weight Loss
The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg.

Secondary Outcome Measures

Full Information

First Posted
May 4, 2012
Last Updated
August 8, 2018
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT01602965
Brief Title
Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet
Official Title
Personalized Nutritional Program Plus a Nutritional Counseling Monthly Phone Call Versus a Personalized Nutritional Program With Self Help Informative Booklet
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the most effectiveness between a personalized nutritional program with a counseling monthly phone call Versus personalized nutritional program with self help Informative Booklet in a group of obesity or overweight patients without counseling phone call.
Detailed Description
Evaluate the best effectiveness between two methods applied in the Dietary Service of institute orthopedic Rizzoli for the achievement of the weight loss. Personalized nutritional program with counseling phone call versus personalized nutritional program with self help Informative Booklet in a controlled group.There will be compared two groups of patients: First group: patients subject to balanced personalized nutritional program associated to counseling monthly phone call ; compliance and loss of weight will be done monthly for one year. Second group: patients subject to balanced personalized nutritional program associated to self help informative Booklet; compliance and loss of weight will be done after six months and after one year from the first meeting.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Overweight
Keywords
obesity, counselling, weight loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
counseling monthly phone calls
Arm Type
Experimental
Arm Description
the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels.
Arm Title
self help informative Booklet
Arm Type
Active Comparator
Arm Description
Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies.
Intervention Type
Procedure
Intervention Name(s)
Counseling Monthly Phone Calls
Intervention Description
the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels.
Intervention Type
Procedure
Intervention Name(s)
Self Help Informative Booklet
Intervention Description
Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies
Primary Outcome Measure Information:
Title
Weight Loss
Description
The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg.
Time Frame
Percent Change in weight loss at one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female and male BMI >25 and <35 Ages Eligible for Study: 18 years old to 75 years old Patients of the Institute Orthopedic Rizzoli subject to personalized nutritional program admitted to the wards and patients attending the clinic of Anaesthesiology, analgesic therapy, Rheumatology participants gave informed consent Exclusion Criteria: Patients with psychiatric disorders (depression, bulimia, anorexia Concomitant use of medicines or food supplements that can alter the weight loss. Patients with inclusion criteria that have not signed the informative report and the declaration of consent.
Facility Information:
Facility Name
Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy

12. IPD Sharing Statement

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Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet

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