ObesityNCT01602965
Effectiveness Between Nutritional Counseling Monthly Phone Call Versus Self Help Informative Booklet
A study testing Counseling Monthly Phone Calls and Self Help Informative Booklet in people with Obesity and Overweight, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Counseling Monthly Phone Calls and Self Help Informative Booklet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2012to Aug 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Nutritional Program Plus a Nutritional Counseling Monthly Phone Call Versus a Personalized Nutritional Program With Self Help Informative Booklet
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.
Read the 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.
- Conditions
- Obesity, Overweight
- Being tested
- Counseling Monthly Phone Calls, Self Help Informative Booklet
- Keywords
- obesity, counselling, weight loss
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling Monthly Phone CallsProcedure or surgery
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.
Self Help Informative BookletProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Counseling Monthly Phone Calls |
| 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. Receives: Procedure: Self Help Informative Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Percent Change in weight loss at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01602965
- Sponsor's protocol ID
- 0008363
- Status last verified
- Aug 2018
- First submitted
- 4 May 2012
- Last updated
- 6 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Nutritional Program Plus a Nutritional Counseling Monthly Phone Call Versus a Personalized Nutritional Program With Self Help Informative Booklet
- ClinicalTrials.gov ID
- NCT01602965
- Acronym / sponsor ID
- 0008363
- Conditions
- Obesity, Overweight
- Keywords
- obesity, counselling, weight loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 21 May 2012 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| counseling monthly phone calls | Experimental | Procedure: Counseling Monthly Phone Callsthe 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 | Procedure: Self Help Informative BookletSelf 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counseling Monthly Phone Callsthe 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. | Procedure or surgery | counseling monthly phone calls |
| Self Help Informative BookletSelf 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 | Procedure or surgery | self help informative Booklet |
Primary outcome
Weight Loss
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling Monthly Phone Calls and Self Help Informative Booklet in people with Obesity and Overweight, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: Percent Change in weight loss at one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.