Promoting Weight Loss and Psychological Well-being in Obese Patients

NCT ID: NCT03962205

Last Updated: 2021-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-10
• Study Completion Date: 2021-03-15

Brief Summary

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.

Detailed 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Cognitive Behavioral life-style and well-being intervention

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.

Group Type: EXPERIMENTAL

cognitive-behavioral life style intervention

Intervention Type: BEHAVIORAL

Cognitive Behavioral life-style modification: The intervention will be composed of 12 weekly sessions. Each session will last about two hours and will be administered in a group setting (maximum 20 participants). During the first two sessions, a clinician will introduce the program to the participants and motivate them to make life-style changes.In the next eight sessions a dietician will provide participants with basics of nutrition and will coach them to use a structured diary to monitor their eating behavior and physical activity. Next, a physician will introduce to the patients various weight loss surgeries in terms of the adverse events, indications and effects of each option.The last session will be held by a psychologist and will focus on providing participants with useful strategies to promote healthy eating habits and physical activity, including problem solving and goal setting.

wellbeing intervention

Intervention Type: BEHAVIORAL

This program will consist of 4 weekly group-based sessions and each meeting will last about two hours. During the sessions, participants will be coached how to self-monitor their well-being episodes in everyday life, especially those associated with life-style change, by means of a structured diary. Patients will be then ecounraged to discuss their well-being experiences during group sessions, focusing on dysfunctional thoughts/beliefs interrupting them, fostering the identification of more functional thoughts. The psychologist will also teach them how to promote well-being situations through behavioral exercises and will introduce to the participants relevant psychological well-being dimensions (based on Carol Ryff's multidimensional model) associated with patients' experiences emerged during the treatment.

treatment as usual

Intervention Type: OTHER

The treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication.

Cognitive Behavioral life-style intervention

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

Group Type: PLACEBO_COMPARATOR

cognitive-behavioral life style intervention

Intervention Type: BEHAVIORAL

Cognitive Behavioral life-style modification: The intervention will be composed of 12 weekly sessions. Each session will last about two hours and will be administered in a group setting (maximum 20 participants). During the first two sessions, a clinician will introduce the program to the participants and motivate them to make life-style changes.In the next eight sessions a dietician will provide participants with basics of nutrition and will coach them to use a structured diary to monitor their eating behavior and physical activity. Next, a physician will introduce to the patients various weight loss surgeries in terms of the adverse events, indications and effects of each option.The last session will be held by a psychologist and will focus on providing participants with useful strategies to promote healthy eating habits and physical activity, including problem solving and goal setting.

treatment as usual

Intervention Type: OTHER

The treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication.

Interventions

cognitive-behavioral life style intervention

Cognitive Behavioral life-style modification: The intervention will be composed of 12 weekly sessions. Each session will last about two hours and will be administered in a group setting (maximum 20 participants). During the first two sessions, a clinician will introduce the program to the participants and motivate them to make life-style changes.In the next eight sessions a dietician will provide participants with basics of nutrition and will coach them to use a structured diary to monitor their eating behavior and physical activity. Next, a physician will introduce to the patients various weight loss surgeries in terms of the adverse events, indications and effects of each option.The last session will be held by a psychologist and will focus on providing participants with useful strategies to promote healthy eating habits and physical activity, including problem solving and goal setting.

Intervention Type: BEHAVIORAL

wellbeing intervention

This program will consist of 4 weekly group-based sessions and each meeting will last about two hours. During the sessions, participants will be coached how to self-monitor their well-being episodes in everyday life, especially those associated with life-style change, by means of a structured diary. Patients will be then ecounraged to discuss their well-being experiences during group sessions, focusing on dysfunctional thoughts/beliefs interrupting them, fostering the identification of more functional thoughts. The psychologist will also teach them how to promote well-being situations through behavioral exercises and will introduce to the participants relevant psychological well-being dimensions (based on Carol Ryff's multidimensional model) associated with patients' experiences emerged during the treatment.

Intervention Type: BEHAVIORAL

treatment as usual

The treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: collaborator

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Chiara Rafanelli

Ordinary Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chiara Rafanelli, MD,PhD

Role: STUDY_DIRECTOR

University of Bologna

Locations

SSD Malattie del Metabolismo e Dietetica Clinica Policlinico Sant'Orsola- Malpighi

Bologna, Emilia-Romagna, Italy

Countries

Italy

References

Fava GA. Well-Being Therapy: Current Indications and Emerging Perspectives. Psychother Psychosom. 2016;85(3):136-45. doi: 10.1159/000444114. Epub 2016 Apr 5. No abstract available.

Reference Type: BACKGROUND

PMID: 27043240 (View on PubMed)

Other Identifiers

PWlPwb-OB

Identifier Type: -

Identifier Source: org_study_id