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OverweightADPB-EMPWNCT01644708

Empowerment and Overweight - a Prospective Observational Study

An observational study of Overweight and Obesity, run by Azienda Per I Servizi Sanitari N. 2 Isontina at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Overweight, Obesity, Power, Personal
What is being tested?
Self empowerment
How many people
80 participants
Where
1 siteItaly
Study dates
Jan 2012to Mar 2013
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All adult persons with BMI equal or above 25

Who may be able to join

  • 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"
  • Final meeting for inclusion in the group and acquisition of informed consent.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Dipartimento di Salute Mentale

    Udine, 33100

Other trials in Italy

About this study

Official title: Th Efficacy of Individual Empowerment on Overweight and Obese Patients - a Prospective Observational Study.

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.

Read the detailed description

With this observational, uncontrolled prospective study we aim to observe any clinical modifications (concerning weight and other health indicators) achieved by a group of overweight and obese persons who underwent a therapy treatment by means of "self-empowerment".

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") an NGO located within the Local Health Unit 4 Medio Friuli, Mental Health Department.

The added value of the strategy proposed by this association is relevant because it is mainly directed to the the improvement of the capacity building of each obese participant instead of focusing only to the food intake. General practice trainees will be dedicated to the evaluation and monitoring of the health status of a group of obese patients included into self-empowerment groups will be assessed for the following year. Major health indicators will be assessed: Body weight, height, waist circumference, brachial blood pressure (two measurements), non-invasive oxymetry.

Some questionnaires will be utilized: Antonovsky's sense of coherence scale, 10-point Likert scale about empowerment, Likert scale about perceived health, Berlin test, Hamilton rating scale for depression.

Blood tests will also be observed. Statistical Analysis A descriptive analysis of all the parameters collected, both the baseline data and those from the 6 and 12- month follow-ups.

For continuous variables (age, weight, BMI…) indicators will be calculated such as the mean, standard deviation, minimum, median and maximum values. The categorical data will be presented by means of frequency tables (n, %).

The changes in the parameters and in the distribution of categorical variables pertaining to the main and secondary outcomes will be assessed by comparing the baseline data collected and those from the 6 and 12-month follow-ups. McNemar's test will be used on the categorical variables, with a level of significance for the p-value fixed at < 0.05. This will allow to record any differences in the distributions of the main factors of interest. T-tests will be used for paired data for assessing changes in the categorical variables.

Being tested
Self empowerment
Keywords
Obesity, Overweight, Individual empowerment, Physical parameters, Self esteem
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Self empowermentBehavioural

    Also called self-empowerment, self-esteem

    1. Group meeting, introducing the method and the assessment tools
    2. Self-empowerment,
    3. Handing over the "journal",
    4. 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.

Study groups in NCT01644708
Study groupRoleWhat they receive
Overweight, obese adult patientsPatients following a self empowerment group will be included in the study
Receives: Behavioral: Self empowerment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decreasing body weight

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

    Measured: 6,12 months

Secondary outcomes (6)

  1. Improved blood pressure control

    Measured: 6 and 12 months

  2. decreasing glycemic levels

    Measured: 6 and 12 months

  3. decreasing total cholesterol values

    Measured: 6 and 12 months

  4. decreasing triglyceride values

    Measured: 6 and 12 months

  5. improvements in the creatinine levels

    Measured: 6 and 12 months

  6. stabilization and improvement of mood and temper (reduction in benzodiazepines and antidepressants)

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01644708
Sponsor's protocol ID
CeformedDSM1
Acronym
ADPB-EMPW
Status last verified
Jun 2013
First submitted
17 Jul 2012
Last updated
10 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 23676799

Questions about this trial

What is this clinical trial studying?

An observational study of Overweight and Obesity, run by Azienda Per I Servizi Sanitari N. 2 Isontina 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 4 inclusion and 6 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 10 Jun 2013. 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. 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?

Decreasing body weight (time frame: 6,12 months). 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 NCT01644708, 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 10 Jun 2013.

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ADPB-EMPW Clinical Trial NCT01644708 | AzTrials