Obesity, Overweight
Conditions
Keywords
obesity, counselling, weight loss
Brief summary
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.
Detailed description
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.
Interventions
PROCEDURECounseling 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.
PROCEDURESelf 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
Sponsors
Istituto Ortopedico Rizzoli
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Female and male * BMI \>25 and \<35 * Ages Eligible for Study: 18 years old to 75 years old * Patients of the Institute Orthopedic Rizzoli subject to personalized nutritional program admitted to the wards and patients attending the clinic of Anaesthesiology, analgesic therapy, Rheumatology * participants gave informed consent
Exclusion criteria
* Patients with psychiatric disorders (depression, bulimia, anorexia * Concomitant use of medicines or food supplements that can alter the weight loss. * Patients with inclusion criteria that have not signed the informative report and the declaration of consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | Percent Change in weight loss at one year | 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. |
Countries
Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| 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 | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 2 |
Baseline characteristics
| Characteristic | Total | Counseling Monthly Phone Calls | Self Help Informative Booklet |
|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 9.87 | 61.6 years STANDARD_DEVIATION 9.08 | 56.5 years STANDARD_DEVIATION 10.67 |
| BMI | 32.69 kg/m^2 STANDARD_DEVIATION 2.55 | 32.94 kg/m^2 STANDARD_DEVIATION 2.69 | 32.45 kg/m^2 STANDARD_DEVIATION 2.41 |
| Sex: Female, Male Female | 22 Participants | 9 Participants | 13 Participants |
| Sex: Female, Male Male | 18 Participants | 11 Participants | 7 Participants |
| Weight | 94.53 kg STANDARD_DEVIATION 11.88 | 96.15 kg STANDARD_DEVIATION 13.81 | 92.91 kg STANDARD_DEVIATION 9.95 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 16 | 0 / 18 |
| other Total, other adverse events | 0 / 16 | 0 / 18 |
| serious Total, serious adverse events | 0 / 16 | 0 / 18 |
Outcome results
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.
Time frame: Percent Change in weight loss at one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Counseling Monthly Phone Calls | Weight Loss | 7.56 percentage of weight loss | Standard Deviation 5.42 |
| Self Help Informative Booklet | Weight Loss | 2.80 percentage of weight loss | Standard Deviation 3.21 |