- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644708
Empowerment and Overweight - a Prospective Observational Study (ADPB-EMPW)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Udine, Italy, 33100
- Dipartimento di Salute Mentale
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Overweight, obese adult patients
Patients following a self empowerment group will be included in the study
|
1. Group meeting, introducing the method and the assessment tools
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decreasing body weight
Time Frame: 6,12 months
|
A persistent reduction of body weight is expected after 6 and 12 months
|
6,12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improved blood pressure control
Time Frame: 6 and 12 months
|
6 and 12 months
|
decreasing glycemic levels
Time Frame: 6 and 12 months
|
6 and 12 months
|
decreasing total cholesterol values
Time Frame: 6 and 12 months
|
6 and 12 months
|
decreasing triglyceride values
Time Frame: 6 and 12 months
|
6 and 12 months
|
improvements in the creatinine levels
Time Frame: 6 and 12 months
|
6 and 12 months
|
stabilization and improvement of mood and temper (reduction in benzodiazepines and antidepressants)
Time Frame: 6 and 12 months
|
6 and 12 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pierluigi Struzzo, MD, Regional Centre for the Training in Primary Care
- Study Director: Mario Novello, MD, Azienda per i Servizi Sanitari Medio Friuli
- Study Chair: Anita Cacitti, dr, Azienda per i Servizi Sanitari Medio Friuli
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CeformedDSM1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Fundació Sant Joan de DéuRecruitingObesity, Childhood | Obesity, AdolescentSpain
-
Consorcio Centro de Investigación Biomédica en...Maimónides Biomedical Research Institute of Córdoba; Instituto de Salud Carlos... and other collaboratorsActive, not recruiting
-
University of HoustonBaylor College of MedicineCompleted
Clinical Trials on Self empowerment
-
Center for Hunger-Free CommunitiesCompletedChild Development | Hunger | Social IsolationUnited States
-
Hunter College of City University of New YorkNational Institute on Minority Health and Health Disparities (NIMHD); National...Active, not recruitingViolence, SexualUnited States
-
Radboud University Medical CenterCompleted
-
University of Texas at AustinCompletedDepression | PTSD | Anxiety | Intimate Partner ViolenceUnited States
-
University of New MexicoPatient-Centered Outcomes Research InstituteCompleted
-
University of British ColumbiaCanadian Diabetes AssociationUnknown
-
Stanford UniversityMedical Research Council, South Africa; African Institute for Health and Development...CompletedViolence, Non-accidental | Sexual Assault and RapeKenya
-
Federal University of Minas GeraisUnknownType 2 Diabetes MellitusBrazil
-
Fakeeh College for Medical SciencesCompleted
-
National Institute of Diabetes and Digestive and...CompletedHypertension | Diabetes