Promoting Weight Loss and Psychological Well-being in Obese Patients: Combination of Behavioral Life Style and Well-Being Intervention
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- University of Bologna
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- 4-month Change in body weight in kg
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Chiara Rafanelli
Ordinary Professor
University of Bologna
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.
Outcomes
Primary Outcomes
4-month Change in body weight in kg
Time Frame: Baseline, 4 months
4-month average change in body weight (kg) from baseline to 4 months. Weight will be measured with a standard balance beam scale with the participant in a lightweight clothing.
4-month Change in body weight in %
Time Frame: Baseline, 4 months
4-month average change in body weight as a percentage of start weight
10-month change in body weight in kg
Time Frame: Baseline, 10 months
10-month average change in body weight (kg) from baseline to 10 months.
10-month change in body weight in %
Time Frame: Baseline, 10 months
10-month average change in body weight as a percentage of start weight
16-month change in body weight in kg
Time Frame: Baseline, 16 months
16-month average change in body weight (kg)
16-month change in body weight in %
Time Frame: Baseline, 16 months
16-month average change in body weight as a percentage of start weight
Change in Body mass Index (BMI)
Time Frame: Baseline, 4 months,10 months,16 months
It will be computed as body weight (kg) divided by the square of height (m²).
Secondary Outcomes
- Change in psychological well-being(Baseline, 4 months,10 months,16 months)
- Change in the prevalence of depression(Baseline, 4 months,10 months,16 months)
- Change in the prevalence of demoralization(Baseline, 4 months,10 months,16 months)
- Change in psychological distress(Baseline, 4 months,10 months,16 months)
- Change in lifestyle(Baseline, 4 months,10 months,16 months)