ObesityAMONCT01297374
Effect of Three Non-drug Intervention in Treatment of Children With Overweight
A study testing physical activities, dietician counseling and behavioral changes in people with Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the effect of three different non-pharmacological interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the percentage of body fat and basal metabolism of… Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Obesity
- What is being tested?
- physical activities, dietician counseling and behavioral changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Apr 2010to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI > +2)
Who cannot join
- chronic diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
About this study
Official title: EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT
The purpose of this study is to compare the effect of three different non-pharmacological interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the percentage of body fat and basal metabolism of children and Overweight and obesity in the metropolitan region of Porto Alegre (RS).
- Conditions
- Obesity
- Being tested
- physical activities, dietician counseling and behavioral changes
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activities, dietician counseling and behavioral changesBehavioural
One arm receive an schedule for physical activities. One arm receive a diet prescription. One arm receive general guidance on diet, physical activity and behavioral changes
| Study group | Role | What they receive |
|---|---|---|
| dietetic counseling | Experimental | Not described Receives: Behavioral: physical activities, dietician counseling and behavioral changes |
| physical activities | Experimental | Not described Receives: Behavioral: physical activities, dietician counseling and behavioral changes |
| Lifestyle counseling | Experimental | Not described Receives: Behavioral: physical activities, dietician counseling and behavioral changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in percentage body fat and basal metabolism after 1 year of randomization
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startApr 2010
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297374
- Sponsor's protocol ID
- HCPA100011
- Other IDs
- HCPA2010
- Acronym
- AMO
- Status last verified
- Feb 2011
- First submitted
- 15 Feb 2011
- Last updated
- 16 Feb 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF THREE NON-DRUG INTERVENTION IN TREATMENT OF CHILDREN WITH OVERWEIGHT
- ClinicalTrials.gov ID
- NCT01297374
- Acronym / sponsor ID
- AMO / HCPA100011
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
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 compare the effect of three different non-pharmacological interventions (usually practiced in ambulatory care of Childhood Obesity (AmO), physical activity program (IFSP) and diet therapy adjusted estimate by indirect calorimetry) on the percentage of body fat and basal metabolism of children and Overweight and obesity in the metropolitan region of Porto Alegre (RS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| dietetic counseling | Experimental | Behavioral: physical activities, dietician counseling and behavioral changes |
| physical activities | Experimental | Behavioral: physical activities, dietician counseling and behavioral changes |
| Lifestyle counseling | Experimental | Behavioral: physical activities, dietician counseling and behavioral changes |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- age 8 to 15 years old with overweight (Z-score BMI +1 e +2) and obesity (Z-score BMI > +2)
Key exclusion criteria (1 listed)
- chronic diseases
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 |
|---|---|---|
| physical activities, dietician counseling and behavioral changesOne arm receive an schedule for physical activities. One arm receive a diet prescription. One arm receive general guidance on diet, physical activity and behavioral changes | Behavioural | Lifestyle counseling, dietetic counseling, physical activities |
Primary outcome
Changes in percentage body fat and basal metabolism after 1 year of randomization
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2011.
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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 physical activities, dietician counseling and behavioral changes in people with Obesity, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Feb 2011. 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 Brazil. 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?
Results are not available in the source record.
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?
Changes in percentage body fat and basal metabolism after 1 year of randomization (time frame: 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 16 Feb 2011.