ObesityNCT03962205
Promoting Weight Loss and Psychological Well-being in Obese Patients
A study testing cognitive-behavioral life style intervention, wellbeing intervention and treatment as usual in people with Obesity, run by University of Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- cognitive-behavioral life style intervention, wellbeing intervention and treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteItaly
- Study dates
- 10 Sep 2018to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- obese (BMI ≥ 30)
- aged ≥18 years
- willing to participate in the study.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site
SSD Malattie del Metabolismo e Dietetica Clinica Policlinico Sant'Orsola- Malpighi
Bologna, Emilia-Romagna, 40138
About this study
Official title: Promoting Weight Loss and Psychological Well-being in Obese Patients: Combination of Behavioral Life Style and Well-Being Intervention
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.
Read the 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
- Being tested
- cognitive-behavioral life style intervention, wellbeing intervention, treatment as usual
- Keywords
- obese patients, psychological well being, weight loss, depression, psychological distress, life-style intervention, demoralization
- Medical subject headings
- Obesity, Psychological Well-Being, Weight Loss, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive-behavioral life style interventionBehavioural
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 interventionBehavioural
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 usualOther
The treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral life-style and well-being intervention | Experimental | 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. Receives: Behavioral: cognitive-behavioral life style intervention; Behavioral: wellbeing intervention; Other: treatment as usual |
| Cognitive Behavioral life-style intervention | Placebo comparator | Participants will receive 12 group-based 2-hour weekly sessions for life-style modification in addition to the treatment as usual. Receives: Behavioral: cognitive-behavioral life style intervention; Other: treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
4-month Change in body weight in kg
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.
Measured: Baseline, 4 months
4-month Change in body weight in %
4-month average change in body weight as a percentage of start weight
Measured: Baseline, 4 months
10-month change in body weight in kg
10-month average change in body weight (kg) from baseline to 10 months.
Measured: Baseline, 10 months
10-month change in body weight in %
10-month average change in body weight as a percentage of start weight
Measured: Baseline, 10 months
16-month change in body weight in kg
16-month average change in body weight (kg)
Measured: Baseline, 16 months
16-month change in body weight in %
16-month average change in body weight as a percentage of start weight
Measured: Baseline, 16 months
Change in Body mass Index (BMI)
It will be computed as body weight (kg) divided by the square of height (m²).
Measured: Baseline, 4 months,10 months,16 months
Secondary outcomes (5)
Change in psychological well-being
It will be measured with the Psychological WellBeing scale, a 42-item self-rating scale, which includes six dimensions: self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life and personal growth. The respondents are asked to indicate on a 6-likert scale the extent to which they agree with each statement. Each dimension may range from 7-42, with higher scores indicating greater psychological well-being.
Measured: Baseline, 4 months,10 months,16 months
Change in the prevalence of depression
It will be measured by well-trained researcher with The Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders - 5th edition (SCID-5-CV).
Measured: Baseline, 4 months,10 months,16 months
Change in the prevalence of demoralization
It will be measured by well-trained researchers with The Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview- Revised (DCPR-R)
Measured: Baseline, 4 months,10 months,16 months
Change in psychological distress
It will be measured by the Symptom Questionnaire (SQ), a 92-item self-rating instrument with dichotomous responses divided into 4 dimensions: depression, anxiety, somatization and hostility/irritability. Each dimension consists in a symptom sub-scale including 17 questions and a well being one with 6 questions. Scores may range from 0 to 17 for each symptom sub-scale and from 0 to 6 for each well-being sub-scale. For each dimension, higher scores indicate more severe psychological distress.
Measured: Baseline, 4 months,10 months,16 months
Change in lifestyle
It will be measured with GOSPEL (GlObal Secondary Prevention strategiEs to Limit event recurrence after myocardial infarction - GOSPEL study) questionnaire, a 32-item self-rating instrument for the assessment of physical activity levels, eating habits, and stress levels used among patients who need to change their lifestyle.
The subscale on physical activity includes eight 4-point items with a total score ranging from 0 (poor/absent physical activity) to 20 (very high physical activity).
The subscale on eating habits consists of ten 4-point items regarding Mediterranean diet based on the frequency of healthy food consumption, with a total score ranging from 0 (worst) to 30 (best). Three additional 4-point items on eating behavior are also included: their total score may range from 0 (bad dietary behavior) to 9 (healthy dietary behavior).
The subscale on stress management includes seven 4-point items which total score may range from 0 (inadequate) to 21 (optimal).
Measured: Baseline, 4 months,10 months,16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start10 Sep 2018
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bologna
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Responsible party
- Principal investigator, Chiara Rafanelli, University of Bologna
- Investigators
- Chiara Rafanelli, MD,PhD, Study director, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962205
- Sponsor's protocol ID
- PWlPwb-OB
- Status last verified
- Jun 2021
- First submitted
- 16 May 2019
- Last updated
- 30 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27043240
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Weight Loss and Psychological Well-being in Obese Patients: Combination of Behavioral Life Style and Well-Being Intervention
- ClinicalTrials.gov ID
- NCT03962205
- Acronym / sponsor ID
- PWlPwb-OB
- Conditions
- Obesity
- Keywords
- obese patients, psychological well being, weight loss, depression, psychological distress, life-style intervention, demoralization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- University of BolognaUniversity, hospital or other
- Collaborators
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 23 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral life-style and well-being intervention | Experimental | Behavioral: cognitive-behavioral life style intervention, Behavioral: wellbeing intervention, Other: treatment as usualParticipants 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. |
| Cognitive Behavioral life-style intervention | Placebo comparator | Behavioral: cognitive-behavioral life style intervention, Other: treatment as usualParticipants will receive 12 group-based 2-hour weekly sessions for life-style modification in addition to the treatment as usual. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obese (BMI ≥ 30)
- aged ≥18 years
- willing to participate in the study.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cognitive-behavioral life style interventionCognitive 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. | Behavioural | Cognitive Behavioral life-style and well-being intervention, Cognitive Behavioral life-style intervention |
| wellbeing interventionThis 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. | Behavioural | Cognitive Behavioral life-style and well-being intervention |
| treatment as usualThe treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication. | Other | Cognitive Behavioral life-style and well-being intervention, Cognitive Behavioral life-style intervention |
Primary outcome
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).
5 secondary outcomes
Change in psychological well-being
Time frame: Baseline, 4 months,10 months,16 months
Change in the prevalence of depression
Time frame: Baseline, 4 months,10 months,16 months
Change in the prevalence of demoralization
Time frame: Baseline, 4 months,10 months,16 months
Change in psychological distress
Time frame: Baseline, 4 months,10 months,16 months
Change in lifestyle
Time frame: Baseline, 4 months,10 months,16 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2021.
- Background: PubMed 27043240Fava 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chiara Rafanelli, MD,PhD study director
University of Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive-behavioral life style intervention, wellbeing intervention and treatment as usual in people with Obesity, run by University of Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4-month Change in body weight in kg (time frame: Baseline, 4 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03962205, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2021.