Ignite Creation Date:
2024-05-06 @ 12:45 AM
Last Modification Date:
2024-10-26 @ 10:54 AM
Study NCT ID:
NCT01644708
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2012-07-17
Brief Title:
Empowerment and Overweight - a Prospective Observational Study
Sponsor:
Azienda Per I Servizi Sanitari N 2 Isontina
Organization:
Azienda Per I Servizi Sanitari N 2 Isontina
Study Overview
Official Title:
Th Efficacy of Individual Empowerment on Overweight and Obese Patients - a Prospective Observational Study
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADPB-EMPW
Brief Summary:
Overweight and obesity put an heavy burden over peoples 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 overweightobese persons
The aim of this study is to observe the effects of an individual empowerment program on the health of a group of overweightobese persons
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 Lets 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 Antonovskys 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 McNemars test will be used on the categorical variables with a level of significance for the p-value fixed at 005 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
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 Lets 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 Antonovskys 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 McNemars test will be used on the categorical variables with a level of significance for the p-value fixed at 005 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None