Breast FeedingNCT00635518
Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants
A study testing Ten Steps for Healthy Feeding children programme in people with Breast Feeding, run by Federal University of Health Science of Porto Alegre.
Trial summary
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Ten Steps for Healthy Feeding children programme
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Mar 2008to Mar 2008
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All pregnant women in the last quarter of the gestation.
Who cannot join
- HIV-positive mothers
- congenital malformation
About this study
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.
Read the detailed description
A cluster randomized controlled trial. Twenty health care service sites were randomly assigned to the intervention or control groups. Health care workers of the intervention health care service sites received training based on the programme "Ten steps for healthy feeding for children from birth to two years old".
Pregnant women, in their third term, were enrolled in the study. At 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.
- Conditions
- Breast Feeding
- Being tested
- Ten Steps for Healthy Feeding children programme
- Keywords
- Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breast Feeding, Overweight, Child, Infant Nutrition Physiology, Public Health
- Medical subject headings
- Breast Feeding, Feeding and Eating Disorders of Childhood, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ten Steps for Healthy Feeding children programmeBehavioural
Also called Infant Nutrition Programme
Ten Steps for Healthy Feeding children
| Study group | Role | What they receive |
|---|---|---|
| I, Intervention | Other | Not described Receives: Behavioral: Ten Steps for Healthy Feeding children programme |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2008
- Study completionMar 2008
Why it stopped: Funding was canceled and no resources are available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Study Withdrawn
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcia Regina Vitolo, Federal University of Health Science of Porto Alegre
- Investigators
- Márcia R Vitolo, postdoctoral, Principal investigator, Federal University of Health Sciences of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00635518
- Sponsor's protocol ID
- vitolo1
- Status last verified
- Aug 2021
- First submitted
- 5 Mar 2008
- Last updated
- 24 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants
- ClinicalTrials.gov ID
- NCT00635518
- Acronym / sponsor ID
- vitolo1
- Conditions
- Breast Feeding
- Keywords
- Health Plan Implementation, Feeding and Eating Disorders of Childhood, Breast Feeding, Overweight, Child, Infant Nutrition Physiology, Public Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was canceled and no resources are available.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- Mar 2008 (actual)
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 13 Mar 2008 (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.
A cluster randomized field trial to evaluate the impact that training healthcare workers in healthy feeding practices has on the nutrition and health of children.
Detailed description
A cluster randomized controlled trial. Twenty health care service sites were randomly assigned to the intervention or control groups. Health care workers of the intervention health care service sites received training based on the programme "Ten steps for healthy feeding for children from birth to two years old".
Pregnant women, in their third term, were enrolled in the study. At 6 and 12 months of age, the mothers were interviewed at home using a semi-structured questionnaire with pre-coded close- and open-ended questions and the children were evaluated.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Study Withdrawn
| Arm | Type | Receives |
|---|---|---|
| I, Intervention | Other | Behavioral: Ten Steps for Healthy Feeding children programme |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pregnant women in the last quarter of the gestation.
Key exclusion criteria (2 listed)
- HIV-positive mothers
- congenital malformation
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 |
|---|---|---|
| Ten Steps for Healthy Feeding children programmeAlso: Infant Nutrition ProgrammeTen Steps for Healthy Feeding children | Behavioural | I, Intervention |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2021.
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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.
Márcia R Vitolo, postdoctoral principal investigator
Federal University of Health Sciences of Porto Alegre
Questions about this trial
What is this clinical trial studying?
A study testing Ten Steps for Healthy Feeding children programme in people with Breast Feeding, run by Federal University of Health Science of Porto Alegre.
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 2 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: withdrawn, as of the sponsor's last update on 24 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 24 Aug 2021.