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

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ClinicalTrials.gov Identifier: NCT01602965
Recruitment Status : Completed
First Posted : May 21, 2012
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Procedure: Counseling Monthly Phone Calls Procedure: Self Help Informative Booklet Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalized Nutritional Program Plus a Nutritional Counseling Monthly Phone Call Versus a Personalized Nutritional Program With Self Help Informative Booklet
Study Start Date : September 2012
Actual Primary Completion Date : July 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: counseling monthly phone calls
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
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.
Active Comparator: self help informative Booklet
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
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 Measures :
  1. Weight Loss [ Time Frame: Percent Change in weight loss at one year ]
    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. Height is measured by a fixed stadiometer, without shoes, to the nearest 0.5 cm.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602965


Locations
Italy
Istituto Ortopedico Rizzoli
Bologna, Italy, 40136
Sponsors and Collaborators
Istituto Ortopedico Rizzoli

Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01602965     History of Changes
Other Study ID Numbers: 0008363
First Posted: May 21, 2012    Key Record Dates
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017
Last Verified: April 2017

Keywords provided by Istituto Ortopedico Rizzoli:
obesity
counselling
weight loss

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms