Promoting Weight Loss and Psychological Well-being in Obese Patients
NCT03962205 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83
Last updated 2021-06-30
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.
Conditions
Interventions
- BEHAVIORAL
-
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.
- 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.
- OTHER
-
treatment as usual
The treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication.
Sponsors & Collaborators
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
collaborator OTHER -
University of Bologna
lead OTHER
Principal Investigators
-
Chiara Rafanelli, MD,PhD · University of Bologna
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-10
- Primary Completion
- 2021-03-15
- Completion
- 2021-03-15
Countries
- Italy
Study Locations
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