Randomized Controlled Trial of Dietary Advice in Primary... | NCT00635518

Studies
Randomized Controlled Trial of Dietary Advice in Primary Care to Promote Healthy Feeding of Infants

NCT00635518

Sponsor

Federal University of Health Science of Porto Alegre

Status

Withdrawn

Last Update Posted

Aug 24, 2021Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Breast Feeding

Interventions

Ten Steps for Healthy Feeding children programme

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding was canceled and no resources are available.

Expanded Access Info

Start Date

Mar 2008Actual

Primary Completion Date

Mar 2008Actual

Completion Date

Mar 2008Actual

First Submitted Date

Mar 5, 2008

First Submission Date that Met QC Criteria

Mar 5, 2008

First Posted Date

Mar 13, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2021

Last Update Posted Date

Aug 24, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcia Regina Vitolo, PhD, Federal University of Health Science of Porto AlegrePrincipal Investigator

Lead Sponsor

Federal University of Health Science of Porto AlegreOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
I, Intervention	Other		Behavioral: Ten Steps for Healthy Feeding children programme

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ten Steps for Healthy Feeding children programme	Behavioral	Ten Steps for Healthy Feeding children	I, Intervention

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- All pregnant women in the last quarter of the gestation.

Exclusion Criteria:

HIV-positive mothers
congenital malformation

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Márcia R Vitolo, postdoctoral	Federal University of Health Sciences of Porto Alegre	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001942	Breast Feeding
D019959	Feeding and Eating Disorders of Childhood
D050177	Overweight

Ancestor Terms

ID	Term
D005247	Feeding Behavior
D001519	Behavior
D001068	Feeding and Eating Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided