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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Personalized Nutritional Program Plus a Nutritional Counseling Monthly Phone Call Versus a Personalized Nutritional Program With Self Help Informative Booklet

Conditions
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Obesity, Overweight

Intervention / Treatment
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* Procedure: Counseling Monthly Phone Calls
* Procedure: Self Help Informative Booklet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: counseling monthly phone calls<br>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. | Procedure: Counseling Monthly Phone Calls<br>* 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.<br>|
| Active Comparator: self help informative Booklet<br>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. | Procedure: Self Help Informative Booklet<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Percent Change in weight loss at one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, counselling, weight loss