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

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Overweight; Obesity

Treatments: Procedure: Counseling Monthly Phone Calls; Procedure: Self Help Informative Booklet

Study type: Interventional

Funder types: Other

Identifiers

NCT01602965

0008363

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

counseling monthly phone calls

Experimental group

Description:

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.

Treatment:

Procedure: Counseling Monthly Phone Calls

self help informative Booklet

Active Comparator group

Description:

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.

Treatment:

Procedure: Self Help Informative Booklet