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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Istituto Ortopedico Rizzoli
Sponsor:
Information provided by (Responsible Party):
Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier:
NCT01602965
First received: May 4, 2012
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Obesity
Overweight
Procedure: Counseling Monthly Phone Calls
Procedure: Self Help Informative Booklet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Istituto Ortopedico Rizzoli:

Primary Outcome Measures:
  • weight loss [ Time Frame: Change from Baseline in Body mass index at one year ] [ Designated as safety issue: No ]

    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.

    Body mass index (BMI) is calculated by taking the weight in Kilograms and dividing it by the height in square meters.



Secondary Outcome Measures:
  • Lifestyle Quality [ Time Frame: baseline and after one year ] [ Designated as safety issue: No ]

    Lifestyle Quality is checked by the "Valuations Questionaire of Life Style" - Institute of Health. The questionnaire asks about aspects of lifestyle that are important influences upon the person's health. The questionnaire aims at assessing the diet and nutrient intake on the basis of frequency and amount of food and alcohol consumptions, and prevalence of physical activity levels.

    The questionnaire will be structured in 31 answers and the patient will be requested to record their responses in the presence of the dietician.



Estimated Enrollment: 72
Study Start Date: September 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602965

Contacts
Contact: Mariela Terrafino, Dietist 00390516366178 cristiana.forni@ior.it

Locations
Italy
Istituto Ortopedico Rizzoli Recruiting
Bologna, Italy, 40136
Contact: Mariela Terrafino, dietician    00390516366178    cristiana.forni@ior.it   
Principal Investigator: Mariela Terrafino, dietician         
Sponsors and Collaborators
Istituto Ortopedico Rizzoli
  More Information

No publications provided

Responsible Party: Istituto Ortopedico Rizzoli
ClinicalTrials.gov Identifier: NCT01602965     History of Changes
Other Study ID Numbers: 0008363
Study First Received: May 4, 2012
Last Updated: June 10, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Istituto Ortopedico Rizzoli:
obesity
counselling
weight loss

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014