NCT03962205

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2018

Typical duration for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
Last Updated

June 30, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

May 16, 2019

Last Update Submit

June 27, 2021

Conditions

Obesity

Keywords

obese patientspsychological well beingweight lossdepressionpsychological distresslife-style interventiondemoralization

Outcome Measures

Primary Outcomes (7)

  • 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.

    Baseline, 4 months

  • 4-month Change in body weight in %

    4-month average change in body weight as a percentage of start weight

    Baseline, 4 months

  • 10-month change in body weight in kg

    10-month average change in body weight (kg) from baseline to 10 months.

    Baseline, 10 months

  • 10-month change in body weight in %

    10-month average change in body weight as a percentage of start weight

    Baseline, 10 months

  • 16-month change in body weight in kg

    16-month average change in body weight (kg)

    Baseline, 16 months

  • 16-month change in body weight in %

    16-month average change in body weight as a percentage of start weight

    Baseline, 16 months

  • Change in Body mass Index (BMI)

    It will be computed as body weight (kg) divided by the square of height (m²).

    Baseline, 4 months,10 months,16 months

Secondary Outcomes (5)

  • 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

Other Outcomes (2)

  • Change in psychosocial profile

    Baseline, 4 months,10 months,16 months

  • Change in motivation for weight change

    Baseline, 4 months,10 months,16 months

Study Arms (2)

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.

Behavioral: cognitive-behavioral life style interventionBehavioral: wellbeing interventionOther: 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.

Behavioral: cognitive-behavioral life style interventionOther: treatment as usual

Interventions

cognitive-behavioral life style interventionBEHAVIORAL

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.

Cognitive Behavioral life-style and well-being interventionCognitive Behavioral life-style intervention
wellbeing interventionBEHAVIORAL

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.

Cognitive Behavioral life-style and well-being intervention
treatment as usualOTHER

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

Cognitive Behavioral life-style and well-being interventionCognitive Behavioral life-style intervention

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obese (BMI ≥ 30)
  • aged ≥18 years
  • willing to participate in the study.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bologna, Emilia-Romagna, 40138, Italy

Location

Related Publications (1)

  • 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.

    PMID: 27043240BACKGROUND

MeSH Terms

Conditions

ObesityPsychological Well-BeingWeight LossDepression

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPersonal SatisfactionBehaviorBody Weight ChangesBehavioral Symptoms

Study Officials

  • Chiara Rafanelli, MD,PhD

    University of Bologna

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ordinary Professor

Study Record Dates

First Submitted

May 16, 2019

First Posted

May 23, 2019

Study Start

September 10, 2018

Primary Completion

March 15, 2021

Study Completion

March 15, 2021

Last Updated

June 30, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)