Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000415000
Ethics application status
Approved
Date submitted
7/05/2010
Date registered
25/05/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Infant-Centered Feeding in a low income population
Scientific title
Early Intervention for the Reduction of Childhood Obesity in Low-Income Populations: A home based Randomized Controlled Trial to assess the effect of infant-centered feeding on maternal responsiveness, feeding styles and feeding practices (Healthy Babies Intervention Trial)
Secondary ID [1] 251676 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257279 0
Condition category
Condition code
Diet and Nutrition 257426 257426 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Healthy Babies Infant-centered feeding from birth - 1 year old. Intervention implemented through 6 in-home lessons before infant is 6 months old
In-home lesson content for infant-centered feeding involves - interpreting hunger and satiety cues and introduction to solid foods
Duration of lessons - 60-80 minutes
Sessions occur weekly or monthly form birth to 6 months of age (based on age of infant at enrollment)
Mode of Administration - Lessons are taught be trained paraprofessional nutrition instructors
Intervention code [1] 256397 0
Prevention
Intervention code [2] 256398 0
Lifestyle
Intervention code [3] 256399 0
Behaviour
Comparator / control treatment
Healthy Families - Active control
Standard treatment of 6 in-home nutrition lessons
Duration of Lessons - 60-80 minutes
Administered - weekly or monthly from birth to 6 months of age (based on age of infant at enrollment)
Mode of Administration - taught by trained paraprofessional nutrition instructors
Control group
Active

Outcomes
Primary outcome [1] 258345 0
Maternal Responsiveness - total score on Parent Child Interaction Feeding Scale
Timepoint [1] 258345 0
At Baseline, 6, and 12 months
Primary outcome [2] 258346 0
Feeding Styles - mean score on Infant Feeding Styles questionnaire (Bentley et al)
Timepoint [2] 258346 0
At baseline, 6, and 12 months
Primary outcome [3] 258347 0
Feeding Practices - frequencies on Infant Feeding checklist
Timepoint [3] 258347 0
At baseline, 6, and 12 months
Secondary outcome [1] 264076 0
Infant weight/length - standardized measurements will be done according to Centers for Disease Control (CDC) guidelines. An infant's weight will be obtained with a scale measuring mass to the nearest ounce, a recumbent length will be used where the infant will be lying down on a flat surface and measurement taken from the top of the infant's head to heel and measured in inches. A z score will be computed for the infant's weight-for-length plotted over time. Categories will be created according to CDC age/sex-specific growth charts, normal (5th through 84th percentile) versus not normal (either below 5th or above 85th or higher of weight-for-length)
Timepoint [1] 264076 0
At baseline, 6, and 12 months

Eligibility
Key inclusion criteria
Low-income population with infants less than 4 months and not started on solid foods
Minimum age
0 Months
Maximum age
4 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male parents
Premature infants with low birthweight or feeding disorders

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment outside Australia
Country [1] 2610 0
United States of America
State/province [1] 2610 0
Michigan
Country [2] 2611 0
United States of America
State/province [2] 2611 0
Colorado

Funding & Sponsors
Funding source category [1] 256900 0
Government body
Name [1] 256900 0
United States Department of Agriculture
Country [1] 256900 0
United States of America
Primary sponsor type
Individual
Name
Mildred Horodynski
Address
Michigan State University
515-G west Fee Hall
East Lansing
MI 48224
Country
United States of America
Secondary sponsor category [1] 256172 0
Individual
Name [1] 256172 0
Susan Baker
Address [1] 256172 0
Colorado State University
1571 Campus Delivery
Fort Collins, CO 80523-1571
Country [1] 256172 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258910 0
Biomedical and Health Institutional Review Board
Ethics committee address [1] 258910 0
Michigan State University
207 Olds Hall
East Lansing, MI 48824
Ethics committee country [1] 258910 0
United States of America
Date submitted for ethics approval [1] 258910 0
02/10/2009
Approval date [1] 258910 0
13/10/2009
Ethics approval number [1] 258910 0
IRB# 08-1064

Summary
Brief summary
Healthy Babies
The goal of this research study is implementation of a relationship skill-building and educational intervention, Healthy Babies (HB) through Infant-Centered Feeding that promotes the development of healthy infant feeding and grwoth through mothers' engagement in infant-centered feeding. objectives are to evaluate effectiveness of the Healthy Babies intervention in the development of infant-centered feeding (defined as maternal responsiveness, feeding style, and feeding practices) as infants transition to solid foods, and infant growth. Healthy Babies, implemented be trained nutrition paraprofessional instrutors, consist of 6 lessona and 3 telephone contact. we expect intervention participants will demonstrate greater increases over time in responsiveness and infant-centered feeding style and feeding practices compared to control participants. The long-term goal of this study is to improve low-income, at risk infants' nutrition and health by addressing childhood obesity through effective intervention promoting the development of healthy eating habits at an early age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31119 0
Address 31119 0
Country 31119 0
Phone 31119 0
Fax 31119 0
Email 31119 0
Contact person for public queries
Name 14366 0
Mildred Horodynski
Address 14366 0
515-G West Fee Hall
East Lansing
MI 48824
Country 14366 0
United States of America
Phone 14366 0
1 517 3558360
Fax 14366 0
1 517 355 5002
Email 14366 0
[email protected]
Contact person for scientific queries
Name 5294 0
Mildred Horodynski/Susan Baker
Address 5294 0
515-G West Fee Hall
East Lansing
MI 48824
OR
1571 Campus Delivery
Fort Collins, CO 80523-1571
Country 5294 0
United States of America
Phone 5294 0
1 970 4915798
Fax 5294 0
Email 5294 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.