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The purpose of this study is to evaluate the most effectiveness between a personalized nutritional program with a counseling monthly phone call Versus personalized nutritional program with self help Informative Booklet in a group of obesity or overweight patients without counseling phone call.
Evaluate the best effectiveness between two methods applied in the Dietary Service of institute orthopedic Rizzoli for the achievement of the weight loss. Personalized nutritional program with counseling phone call versus personalized nutritional program with self help Informative Booklet in a controlled group.There will be compared two groups of patients: First group: patients subject to balanced personalized nutritional program associated to counseling monthly phone call ; compliance and loss of weight will be done monthly for one year. Second group: patients subject to balanced personalized nutritional program associated to self help informative Booklet; compliance and loss of weight will be done after six months and after one year from the first meeting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| counseling monthly phone calls | Experimental | the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. |
|
| self help informative Booklet | Active Comparator | Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Counseling Monthly Phone Calls | Procedure | the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg. | Percent Change in weight loss at one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituto Ortopedico Rizzoli | Bologna | 40136 | Italy |
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| ID | Title | Description |
|---|---|---|
| FG000 | Counseling Monthly Phone Calls | the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels. |
| FG001 | Self Help Informative Booklet | Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Counseling Monthly Phone Calls | the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Weight Loss | The measure of weight must be detected with the help of a balance. Weight is measured using Professional Dial Column Scales without shoes or heavy clothing to the nearest 0.1 kg. | Posted | Mean | Standard Deviation | percentage of weight loss | Percent Change in weight loss at one year |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Counseling Monthly Phone Calls | the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviours that need to be changed, problem-solving as to how to make the changes and physical activity levels. Counseling Monthly Phone Calls: the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mariela Terrafino | Istituto Ortopedico Rizzoli | 0516366694 | 0039 | cristiana.forni@ior.it |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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|
| Self Help Informative Booklet | Procedure | Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies |
|
| BG001 | Self Help Informative Booklet | Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Weight | Mean | Standard Deviation | kg |
|
| OG001 | Self Help Informative Booklet | Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Self Help Informative Booklet | Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies. Self Help Informative Booklet: Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies | 0 | 18 | 0 | 18 | 0 | 18 |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |