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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Procedure: Self Help Informative Booklet; Procedure: Counseling Monthly Phone Calls

• Registration Number: NCT01602965
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2012-05-04
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Study Start: 2012-09
• Primary Completion: 2016-07
• Study Completion: 2016-08
• Results First Submitted: 2017-02-03
• Results First Submitted QC: 2017-04-20
• Results First Posted: 2017-08-02
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-08
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
self help informative Booklet	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.
counseling monthly phone calls	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.

Primary Outcome Measures

Name	Time	Method
Weight Loss	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.

Trial Locations

Locations (1)

Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy