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Trial registered on ANZCTR


Registration number
ACTRN12610000981022
Ethics application status
Approved
Date submitted
12/11/2010
Date registered
15/11/2010
Date last updated
12/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A nutrition intervention research project for low-income mothers of toddlers
Scientific title
The Healthy Toddlers' Trial: An intervention for the reduction of childhood obesity in low-income populations. A home based Randomized Controlled Trial to assess the effect of promoting healthy eating behaviors in young children while dietary habits are forming on maternal child-feeding style, maternal child-feeding interaction and child eating behavior.
Secondary ID [1] 252381 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 257891 0
Condition category
Condition code
Diet and Nutrition 258052 258052 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Healthy Toddlers (HT) consists of eight in-home lessons, followed by four weekly reinforcement telephone calls, focusing on increasing toddlers' intake of fruits and vegetables; decreasing the amount of sweetened beverages consumed; and enhancing parental feeding behaviors.

Duration of Lessons: 60 to 90 minutes, administered once a week for 8 weeks targeting low-income mothers with toddlers 1 - 3 years.

Mode of Administration: Lessons are taught by trained paraprofessional nutrition instructors.
Intervention code [1] 256943 0
Prevention
Intervention code [2] 256956 0
Lifestyle
Intervention code [3] 256957 0
Behaviour
Comparator / control treatment
Active control Standard treatment of 8 in-home lessons that focus on basic nutrition messages, and food budgeting and menu planning, but not on feeding toddlers.

Duration of Lessons: 60 to 90 minutes, administered once a week for 8 weeks targeting low-income mothers with toddlers 1 - 3 years.

Mode of Administration: Lessons are taught by trained paraprofessional nutrition instructors.
Control group
Active

Outcomes
Primary outcome [1] 258928 0
Maternal child-feeding style-mean score in the Child Feeding Questionnaire
Timepoint [1] 258928 0
Baseline (before the first lesson), post (after the eighth lesson), and at six months post
Primary outcome [2] 258929 0
Maternal child-feeding interaction-mean score in the Parent-Toddler Mealtime Behavior Questionnaire and Observation
Timepoint [2] 258929 0
Baseline (before the first lesson), post (after the eighth lesson), and at six months post
Primary outcome [3] 258930 0
Child eating behavior-3 day Food Frequency Questionnaire
Timepoint [3] 258930 0
Baseline (before the first lesson), post (after the eighth lesson), and at six months post
Secondary outcome [1] 266307 0
Toddler weight/height-standardized measurements will be done according to Centers for Disease Control (CDC) guidelines and World Health Organization (WHO) guidelines. A toddler's weight will be attained with a digital scale measuring mass to the nearest ounce; a recumbent length or height will be used (depending on the toddler's age). A z score will be computed for the toddler's weight-for-height (length) plotted over time. Categories will be created according to CDC/WHO age/sex specific growth charts. Normal (5th and above and below 84th percentile) versus not normal (either below 5th ~ above 85th) or higher weight-for-height (length).
Timepoint [1] 266307 0
At baseline, at the 8th lesson, at at six months post

Eligibility
Key inclusion criteria
Low-income population with toddlers 1 to 3 years.
Minimum age
1 Years
Maximum age
3 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Male parents. Neither the mother nor toddler could have diagnosed eating, physical, or chronic health problems that would interfere with the intervention such as an eating disorder.

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
Completed
Date of first participant enrolment
Anticipated
9/10/2007
Actual
1/01/2010
Date of last participant enrolment
Anticipated
Actual
10/01/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment outside Australia
Country [1] 2805 0
United States of America
State/province [1] 2805 0
Michigan, Colorado, Wisconsin

Funding & Sponsors
Funding source category [1] 257394 0
Government body
Name [1] 257394 0
United States Department of Agriculture
Country [1] 257394 0
United States of America
Primary sponsor type
Individual
Name
Susan Baker
Address
Colorado State University
1571 Campus Delivery
Fort Collins
CO 80523-1571
Country
United States of America
Secondary sponsor category [1] 256630 0
Individual
Name [1] 256630 0
Mildred Horodynski
Address [1] 256630 0
Michigan State University
515-G West Fee Hall
East Lansing
MI 48224
Country [1] 256630 0
United States of America

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259417 0
Biomedical and Health Institutional Review Board
Ethics committee address [1] 259417 0
Michigan State University
207 Olds Hall
East Lansing
MI 48824
Ethics committee country [1] 259417 0
United States of America
Date submitted for ethics approval [1] 259417 0
Approval date [1] 259417 0
Ethics approval number [1] 259417 0

Summary
Brief summary
The goal of this project for low-income parents of children ages one to three is to promote healthy eating behaviors in young children. Critical factors address obesity prevention, specifically food consumption and the mealtime environment. Our objectives are to : (1) promote the development of healthy eating behaviors in young children while dietary habits are forming; (2) demonstrate that nutrition education provided through a multi-state intervention is effective in promoting healthy eating behaviors in young children; and (3) demonstrate that 'Healthy Toddlers' is a sustainable intervention with existing programs. Delivered by Extension paraprofessionals, eight in-home lessons (plus four telephone follow-up reinforcement contacts) are based on the social cognitive theory which addresses the influence of social, psychological and cognitive factors on health behaviors. A randomized experimental, short-term longitudinal design is proposed with intervention and control groups (300 participants per group), with three assessment periods: baseline, post assessment, and delayed post [six months after post]. Toddler eating skills and diet, and maternal toddler-feeding style, are assessed through parent self-report and in-home mealtime observations. Child and maternal BMI will be directly measured. Subjects in the intervention group are expected to demonstrate more positive dietary and eating skills and feeding interactions than the controls. The project's long-term goal is to improve the nation's nutrition and health by addressing childhood obesity through an 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 31476 0
Dr Mildred Horodynski
Address 31476 0
Michigan State University
1355 Bogue Street, C-244, East Lansing, MI, 48824
Country 31476 0
United States of America
Phone 31476 0
15173558060
Fax 31476 0
Email 31476 0
millie@msu.edu
Contact person for public queries
Name 14723 0
Dr Mildred Horodynski
Address 14723 0
Michigan State University
1355 Bogue Street, C-244, East Lansing, MI, 48824
Country 14723 0
United States of America
Phone 14723 0
1 517 3558060
Fax 14723 0
1 517 3555002
Email 14723 0
millie@msu.edu
Contact person for scientific queries
Name 5651 0
Dr Susan Baker
Address 5651 0
1571 Campus Delivery
Fort Collins
CO 80523-1571
Country 5651 0
United States of America
Phone 5651 0
1 970 4915798
Fax 5651 0
1 970 4917252
Email 5651 0
susan.baker@colostate.edu

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
SourceTitleYear of PublicationDOI
Dimensions AIThe Healthy Toddlers Trial Protocol: An Intervention to Reduce Risk Factors for Childhood Obesity in Economically and Educationally Disadvantaged Populations2011https://doi.org/10.1186/1471-2458-11-581
N.B. These documents automatically identified may not have been verified by the study sponsor.