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NCT Number: NCT03962205

Promoting Weight Loss and Psychological Well-being in Obese Patients

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.

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Key information

Conditions

Obesity Behavior Behavioral Symptoms Body Weight Body Weight Changes Depression Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Signs and Symptoms Weight Loss

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bologna, Emilia-Romagna, 40138, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

cognitive-behavioral life style intervention

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

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

Other

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 16-month change in body weight in kg

    Time frame: Baseline, 16 months

    16-month average change in body weight (kg)

  6. 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

  7. 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

  1. Change in psychological well-being

    Time frame: Baseline, 4 months,10 months,16 months

    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.

  2. Change in the prevalence of depression

    Time frame: Baseline, 4 months,10 months,16 months

    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).

  3. Change in the prevalence of demoralization

    Time frame: Baseline, 4 months,10 months,16 months

    It will be measured by well-trained researchers with The Diagnostic Criteria for Psychosomatic Research-Revised Semi-Structured Interview- Revised (DCPR-R)

  4. Change in psychological distress

    Time frame: Baseline, 4 months,10 months,16 months

    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.

  5. Change in lifestyle

    Time frame: Baseline, 4 months,10 months,16 months

    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).

Other outcomes

  1. Change in psychosocial profile

    Time frame: Baseline, 4 months,10 months,16 months

    It will be measured with the PsychoSocial Index (PSI). PSI is a 55-item self-rating scale, divided into 5 domains: 1) Sociodemographic and clinical data (12 questions on medical and demographic information); 2) Stress subscale (17 yes/no questions) with a score ranging from 0 to 17 (a higher score indicates greater stress); 3) Well-being subscale (6 yes/no questions) with a score ranging from 0 to 6 (a higher score indicates greater psychological well-being); 4) Psychological distress (15 four-point questions ranging from 0 to 3) with a total score from 0 to 45 (a higher score indicates greater psychological distress); 5) Abnormal Illness Behavior (3 four-point questions from 0 to 3) with a total score ranging from 0 to 9 (a higher score indicates more severe abnormal illness behavior). Finally, PSI includes one 4-point question on self-perceived quality of life, with a score from 0 to 4 (a higher score indicates better quality of life).

  2. Change in motivation for weight change

    Time frame: Baseline, 4 months,10 months,16 months

    It will be measured by the Goal Related Weight Questionnaire (GRWQ), which asks the respondents to self-report their dream, happy, acceptable, and disappointed weight in kilograms in the first part (4 items) and to indicate to which extent they expect weight loss to impact various aspects of their psycho-social and health-related functioning, with each item scored from 1 (extremely negative) to 10 (extremely positive), in the second part (21 items).

Sponsors and collaborators

Lead sponsor

University of Bologna

Other

Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

Registry information

Official study title

Promoting Weight Loss and Psychological Well-being in Obese Patients: Combination of Behavioral Life Style and Well-Being Intervention

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 23, 2019
Registry last updated
Jun 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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