Clinical trial NCT03962205: Promoting Weight Loss and Psychological Well-being in Obese Patients
Official title: Promoting Weight Loss and Psychological Well-being in Obese Patients: Combination of Behavioral Life Style and Well-Being Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: obese patients
psychological well being
weight loss
depression
psychological distress
life-style intervention
demoralization
Lead sponsor: University of Bologna
Sponsor class: OTHER
Collaborators: name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
First posted: 2019-05-23
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 4-month Change in body weight in kg
timeFrame: Baseline, 4 months
measure: 4-month Change in body weight in %
timeFrame: Baseline, 4 months
measure: 10-month change in body weight in kg
timeFrame: Baseline, 10 months
measure: 10-month change in body weight in %
timeFrame: Baseline, 10 months
measure: 16-month change in body weight in kg
timeFrame: Baseline, 16 months
measure: 16-month change in body weight in %
timeFrame: Baseline, 16 months
measure: Change in Body mass Index (BMI)
timeFrame: Baseline, 4 months,10 months,16 months
Secondary outcomes:
measure: Change in psychological well-being
timeFrame: Baseline, 4 months,10 months,16 months
measure: Change in the prevalence of depression
timeFrame: Baseline, 4 months,10 months,16 months
measure: Change in the prevalence of demoralization
timeFrame: Baseline, 4 months,10 months,16 months
measure: Change in psychological distress
timeFrame: Baseline, 4 months,10 months,16 months
measure: Change in lifestyle
timeFrame: Baseline, 4 months,10 months,16 months
Other outcomes:
measure: Change in psychosocial profile
timeFrame: Baseline, 4 months,10 months,16 months
measure: Change in motivation for weight change
timeFrame: Baseline, 4 months,10 months,16 months
Locations:
city: Bologna
country: Italy
facility: SSD Malattie del Metabolismo e Dietetica Clinica Policlinico Sant'Orsola- Malpighi
state: Emilia Romagna
Study officials:
affiliation: University of Bologna
name: Chiara Rafanelli, MD,PhD
role: STUDY_DIRECTOR
References:
citation: 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.