ANZCTR - Registration

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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]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Condition category

Condition code

Diet and Nutrition

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]

Prevention

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Maternal child-feeding style-mean score in the Child Feeding Questionnaire

Timepoint [1]

Baseline (before the first lesson), post (after the eighth lesson), and at six months post

Primary outcome [2]

Maternal child-feeding interaction-mean score in the Parent-Toddler Mealtime Behavior Questionnaire and Observation

Timepoint [2]

Baseline (before the first lesson), post (after the eighth lesson), and at six months post

Primary outcome [3]

Child eating behavior-3 day Food Frequency Questionnaire

Timepoint [3]

Baseline (before the first lesson), post (after the eighth lesson), and at six months post

Secondary outcome [1]

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]

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]

United States of America

State/province [1]

Michigan, Colorado, Wisconsin

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

United States Department of Agriculture

Address [1]

1400 Independence Ave., S.W.
Washington, DC 20250

Country [1]

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]

Individual

Name [1]

Mildred Horodynski

Address [1]

Michigan State University
515-G West Fee Hall
East Lansing
MI 48224

Country [1]

United States of America

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Biomedical and Health Institutional Review Board

Ethics committee address [1]

Michigan State University 
207 Olds Hall 
East Lansing 
MI 48824

Ethics committee country [1]

United States of America

Date submitted for ethics approval [1]

Approval date [1]

Ethics approval number [1]

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

Dr Mildred Horodynski

Address

Michigan State University
1355 Bogue Street, C-244, East Lansing, MI, 48824

Country

United States of America

Phone

15173558060

Fax

millie@msu.edu

Contact person for public queries

Name

Mildred Horodynski

Address

Michigan State University
1355 Bogue Street, C-244, East Lansing, MI, 48824

Country

United States of America

Phone

1 517 3558060

Fax

1 517 3555002

millie@msu.edu

Contact person for scientific queries

Name

Susan Baker

Address

1571 Campus Delivery
Fort Collins
CO 80523-1571

Country

United States of America

Phone

1 970 4915798

Fax

1 970 4917252

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

Source	Title	Year of Publication	DOI
Dimensions AI	The Healthy Toddlers Trial Protocol: An Intervention to Reduce Risk Factors for Childhood Obesity in Economically and Educationally Disadvantaged Populations	2011	https://doi.org/10.1186/1471-2458-11-581

N.B. These documents automatically identified may not have been verified by the study sponsor.

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