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

NCT01602965 | Completed Results

• 1 other identifier: 0008363
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight

Keywords

obesity; counselling; weight loss

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

counseling monthly phone calls

EXPERIMENTAL

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

self help informative Booklet

ACTIVE COMPARATOR

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

Interventions

Counseling Monthly Phone Calls PROCEDURE

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.

counseling monthly phone calls

Self Help Informative Booklet PROCEDURE

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

self help informative Booklet

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with psychiatric disorders (depression, bulimia, anorexia
• Concomitant use of medicines or food supplements that can alter the weight loss.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Results Point of Contact

• Title: Mariela Terrafino
• Organization: Istituto Ortopedico Rizzoli

cristiana.forni@ior.it

0516366694

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2012
• First Posted: May 21, 2012
• Study Start: September 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 6, 2018
• Results First Posted: August 2, 2017

Record last verified: 2018-08

Locations

IT (1)