NCT01644708

Brief Summary

Overweight and obesity put an heavy burden over people's health. Many methods are reported in medical literature but none of them proved to be effective in maintaining the results achieved over time. Motivational change remains a fundamental step towards the maintenance of a new lifestyle. Strengthening personal capabilities and self-esteem seem to be key strategies in motivating persons for change and facilitating a capacity of coping. The aim of this study is to observe the effects of an individual empowerment program on the health of a group of overweight/obese persons.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 19, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

July 17, 2012

Last Update Submit

June 6, 2013

Conditions

OverweightObesityPower, Personal

Keywords

ObesityOverweightIndividual empowermentPhysical parametersSelf esteem

Outcome Measures

Primary Outcomes (1)

  • Decreasing body weight

    A persistent reduction of body weight is expected after 6 and 12 months

    6,12 months

Secondary Outcomes (6)

  • Improved blood pressure control

    6 and 12 months

  • decreasing glycemic levels

    6 and 12 months

  • decreasing total cholesterol values

    6 and 12 months

  • decreasing triglyceride values

    6 and 12 months

  • improvements in the creatinine levels

    6 and 12 months

  • +1 more secondary outcomes

Study Arms (1)

Overweight, obese adult patients

Patients following a self empowerment group will be included in the study

Behavioral: Self empowerment

Interventions

Self empowermentBEHAVIORAL

1\. Group meeting, introducing the method and the assessment tools 1. Self-empowerment, 2. Handing over the "journal", 3. Questionnaire about emotional states and motivations for losing weight and for change. The group meetings, lasting one hour and a half, will take place every week, always on the same day and at the same time, for one year. During each meeting the participant "weighs himself" and he notes his weight down in his journal.

Also known as: self-empowerment, self-esteem
Overweight, obese adult patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult persons with BMI equal or above 25

You may qualify if:

  • \- The study will include all adults, with a Body Mass Index (BMI) above 25, entering the new "therapy groups" of the project, named "Diamo Peso al Benessere" ("Let's Give Weight to Well-Being"), (Local Health Unit 4 Medio Friuli, Mental Health Department). Before being included in the therapy groups, persons will undergo three individual in-depth interviews with an empowerment consultant, with:
  • Verification of the motivation (Importance of the problem + Self-esteem, Likert scales 0 -10)
  • Request to underwrite the "therapy contract"

You may not qualify if:

  • \- minors will be excluded and
  • those who must shed weight in a short time because of planned surgery,
  • those who suffer from severe health problems (severe stroke outcomes, heart or kidney failure, neoplasia)
  • those who want to lose weight only for esthetic reasons,
  • those who cannot guarantee regular weekly attendance for the treatment,
  • those who also use other means for losing weight (weight-loss surgery, psychoanalysis, or other nutritional regimens).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dipartimento di Salute Mentale

Udine, 33100, Italy

Location

Related Publications (1)

  • Struzzo P, Fumato R, Tillati S, Cacitti A, Gangi F, Stefani A, Torcutti A, Crapesi L, Tubaro G, Balestrieri M. Individual empowerment in overweight and obese patients: a study protocol. BMJ Open. 2013 May 14;3(5):e002669. doi: 10.1136/bmjopen-2013-002669.

    PMID: 23676799DERIVED

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pierluigi Struzzo, MD

    Regional Centre for the Training in Primary Care

    PRINCIPAL INVESTIGATOR

  • Mario Novello, MD

    Azienda per i Servizi Sanitari Medio Friuli

    STUDY DIRECTOR

  • Anita Cacitti, dr

    Azienda per i Servizi Sanitari Medio Friuli

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Area Responsible

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 19, 2012

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

IT(1)