Effectiveness of Cognitive Behavioral Therapy vs. Prescriptive Diet in Short and Medium-term Control of Body Weight

NCT01686854 | Unknown DMC

• 1 other identifier: PSMCM01
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 1

Brief Summary

Comparison between different treatments of obesity in the short and medium term: prescriptive diet therapy compared to to cognitive-behavioral approach in the treatment of obesity according to the method of clinical trial. According to the Italian guidelines on obesity, the target to reach is the weight loss of 10% compared to the initial weight, obtained in six months and maintained for the next 5 years. The guideline considers six months as the time required to lose weight, but many patients are not able to achieve this result. Since in clinical practice many patients fail to achieve this weight loss in six months, it was decided to extend to 12 months the time to reach the target. As an intermediate goal it has been proposed to achieve a weight loss of at least 5% on respect of the basal weight in six months.

Conditions

Obesity

Keywords

cognitive-behavioral approach; obesity treatment

Outcome Measures

Primary Outcomes (1)

• body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight

  body weight reduction by 10% compared to the initial weight to over 12 months achievement of weight loss corresponding to 10% of the initial weight in 12 months. It will be considered responder to therapy who reach such a result in 12 months

  12 months

Secondary Outcomes (3)

• body weight reduction by 5% compared to the initial weight

  6 months

• cardiovascular risk

  6, 12, 24 months

• Attrition in the two groups

  6, 12, 24 months

Study Arms (2)

Cognitive Behavioral (B)

EXPERIMENTAL

a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies.

Behavioral: Cognitive Behavioral (B)

Prescriptive Diet (A)

ACTIVE COMPARATOR

prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003).

Other: Prescriptive Diet (A)

Interventions

Cognitive Behavioral (B) BEHAVIORAL

a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies.

Cognitive Behavioral (B)

Prescriptive Diet (A) OTHER

prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003).

Prescriptive Diet (A)

Eligibility Criteria

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

You may not qualify if:

• patients treated with anorectic, estrogen or progestin and patients with diabetes or eating disordes were excluded.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Clinica Medica 2A

Pavia, PV, 27100, Italy

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Chiara Muggia, MD

  Clinica Medica 2a

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dirigente medico 1° livello

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: September 18, 2012
• Study Start: March 1, 2007
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: September 18, 2012

Record last verified: 2012-09

Locations

IT (1)