Promoting Weight Loss and Psychological Well-being in Obese Patients

University of Bologna

Status: Completed

Conditions: Obesity

Treatments: Behavioral: cognitive-behavioral life style intervention; Other: treatment as usual; Behavioral: wellbeing intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03962205

PWlPwb-OB

Details and patient eligibility

About

The goal of the proposed research is to assess the effects of a sequential combination of lifestyle and well-being intervention on weight loss and psychological well-being. It is hypothesized that psychological well-being promotion as an adjunct to life-style intervention will outperform life style intervention alone in promoting weight loss and psychological well-being in obese individuals.

Full description

The present study is a longitudinal, single blind, randomized controlled pilot trial. The participants will be recruited at the Center of Metabolism Diseases and Clinical Dietetics of Sant'Orsola Hospital in Bologna, directed by Prof. Giulio Marchesini Reggiani, after approval of the Ethics Committee of Azienda Ospedaliero-Universitaria of Bologna.

Patients attending the Center of Metabolism Diseases and Clinical Dietetics during the enrollment period will be screened for inclusion and exclusion criteria by care coordinators or clinicians. Eligible patients will be required to sign the informed consent form and the consent form for personal data processing. The researchers will be in charge of explaining the project to make sure that it is fully understood by the patients.

During the first 3 months, all the participants will undergo a behavioral program focusing on lifestyle modification. The participants who accomplish the program for life-style modification will be randomly assigned to either the control group or the experimental group. Generalized block randomization will be carried out by a computer program (the Random Allocation Software 2.0), with an allocation ratio of 1:1.

Participants in the experimental group will receive a four-session intervention on psychological well-being. Each session will last one hour and will be offered weekly, based on the principles of Well-Being Therapy. Patients in the control group will only receive a treatment as usual (TAU), according to the instructions given by their clinicians. Data will be collected for each participant through questionnaires and interviews at baseline, at the end of the life-style intervention, at the end of the well-being intervention, and at 6 months of follow-up after the intervention. Given the nature of this study, it will not be possible for participants and treatment delivers to be blinded. Trained researchers, masked to the experimental allocation of patients, will perform measurements and analyses of the data to minimize potential bias.

Enrollment: 83 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• obese (BMI ≥ 30)
• aged ≥18 years
• willing to participate in the study.

Exclusion criteria

• inability to provide informed consent to participate in the study (i.e. psychotic or mentally impaired patients);
• insufficient knowledge of Italian;
• presence of a medical condition associated with unintentional weight loss or gain;
• presence of major psychiatric illness and cognitive deficit;
• participation in another weight-loss program;
• use of medication for weight loss;
• history of weight loss surgery or weight loss surgery scheduled during the last year or within 16 months from the beginning of the study;
• being pregnant or intended pregnancy during the last year or within 16 months from the beginning of the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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83 participants in 2 patient groups, including a placebo group

Cognitive Behavioral life-style and well-being intervention

Experimental group

Description:

Participants will receive 12 group-based 2-hour weekly sessions for life-style modification and then 4 group-based 2-hour weekly sessions of the well-being intervention in addition to the treatment as usual.

Treatment:

Behavioral: cognitive-behavioral life style intervention

Other: treatment as usual

Behavioral: wellbeing intervention

Cognitive Behavioral life-style intervention

Placebo Comparator group

Description:

Participants will receive 12 group-based 2-hour weekly sessions for life-style modification in addition to the treatment as usual.

Treatment:

Behavioral: cognitive-behavioral life style intervention

Other: treatment as usual