CompletedNot Applicable

Empowerment and Overweight - a Prospective Observational Study

Italy80 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- 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. Exclusion Criteria: \- 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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Decreasing body weight

Timeframe: 6,12 months

Trial details

NCT IDNCT01644708

SponsorAzienda Per I Servizi Sanitari N. 2 Isontina

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2013-03

View on ClinicalTrials.gov More Overweight trials