Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet
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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 |
- 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.
- 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 2015 |
| Estimated Primary Completion Date: | May 2014 (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 |
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| Contact: Mariela Terrafino, Dietist | 00390516366178 | cristiana.forni@ior.it |
| Italy | |
| Istituto Ortopedico Rizzoli | Recruiting |
| Bologna, Italy, 40136 | |
| Contact: Mariela Terrafino, dietician 00390516366178 cristiana.forni@ior.it | |
| Principal Investigator: Mariela Terrafino, dietician | |
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: | December 5, 2012 |
| 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 May 16, 2013