search
Back to results

Anticipatory Guidance to Prevent Childhood Obesity (MOMS)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Maternal focused intervention
Ounce of Prevention
Sponsored by
Nationwide Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring well child visit, anticipatory guidance, obesity prevention, infant feeding

Eligibility Criteria

2 Weeks - 2 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Maternal/infant pairs Infant under 2 months of age Mother English speaking

Exclusion Criteria:

History of Neonatal ICU stay in infant Gestation less than 37 weeks in infant chronic disease in infant known genetic disorder in infant foster care placement in infant

Sites / Locations

  • Nationwide Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Active Comparator

Arm Label

Bright Futures

Maternal focused intervention

Ounce of Prevention

Arm Description

This represents 'usual care' in the pediatric office. The anticipatory guidance regarding nutrition is based on the Bright Futures Pocket Guide.

Childhood obesity prevention was approached in this arm via anticipatory guidance aimed at maternal eating habits.

This is a program of anticipatory guidance given to mothers of infants ages 2 weeks to one year which focuses on serving size per age and tips for introducing new foods for the infant.

Outcomes

Primary Outcome Measures

Infant weight for height
Infant weight for height will be assessed to see if proportions of elevated weight for height are lower in intervention groups as compared to usual care.

Secondary Outcome Measures

Maternal feeding behaviors
Several maternal feeding behaviors, including amount of vegetables and fruit offered to infant, eating as a 'family', amount of television watching by the infant, and juice intake by the infant were secondary outcomes.

Full Information

First Posted
March 26, 2012
Last Updated
March 27, 2012
Sponsor
Nationwide Children's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01565525
Brief Title
Anticipatory Guidance to Prevent Childhood Obesity
Acronym
MOMS
Official Title
Can Changing How Moms Eat Prevent Obesity in Toddlers?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this pilot project is to test anticipatory guidance, which is information given to families during a well child visit to prevent obesity during childhood. The objectives were to compare two styles of anticipatory guidance during the first year of life, maternal focused and infant focused, versus usual care and determine which style, if any, showed the most ideal infant feeding behaviors at age 1 year and to see if there were any differences in infant weight for height at one year of age. The investigators hypothesized that mothers who received the maternal focused anticipatory guidance (which gave information on eating family meals, not having tv on during meals, and maternal nutrition) would actually have the best infant feeding behaviors and weight for height of infants at one year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
well child visit, anticipatory guidance, obesity prevention, infant feeding

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
306 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bright Futures
Arm Type
No Intervention
Arm Description
This represents 'usual care' in the pediatric office. The anticipatory guidance regarding nutrition is based on the Bright Futures Pocket Guide.
Arm Title
Maternal focused intervention
Arm Type
Experimental
Arm Description
Childhood obesity prevention was approached in this arm via anticipatory guidance aimed at maternal eating habits.
Arm Title
Ounce of Prevention
Arm Type
Active Comparator
Arm Description
This is a program of anticipatory guidance given to mothers of infants ages 2 weeks to one year which focuses on serving size per age and tips for introducing new foods for the infant.
Intervention Type
Behavioral
Intervention Name(s)
Maternal focused intervention
Other Intervention Name(s)
MOMS
Intervention Description
This is a series of information given to mothers at child's well child visits (6 in all) starting at the newborn visit focused in maternal eating habits, using the mother as a potential 'agent of change' for the family and infant in modeling healthy eating habits.
Intervention Type
Behavioral
Intervention Name(s)
Ounce of Prevention
Other Intervention Name(s)
"Ounce"
Intervention Description
This intervention is given via a series of handouts given to mothers at their child's well visit from newborn period to one year of age, focusing on serving size and frequency and the introduction of new foods.
Primary Outcome Measure Information:
Title
Infant weight for height
Description
Infant weight for height will be assessed to see if proportions of elevated weight for height are lower in intervention groups as compared to usual care.
Time Frame
One year after study entry
Secondary Outcome Measure Information:
Title
Maternal feeding behaviors
Description
Several maternal feeding behaviors, including amount of vegetables and fruit offered to infant, eating as a 'family', amount of television watching by the infant, and juice intake by the infant were secondary outcomes.
Time Frame
One year after study entry.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Maternal/infant pairs Infant under 2 months of age Mother English speaking Exclusion Criteria: History of Neonatal ICU stay in infant Gestation less than 37 weeks in infant chronic disease in infant known genetic disorder in infant foster care placement in infant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Groner, MD
Organizational Affiliation
Nationwide Children's Hospital, Columbus Ohio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19246415
Citation
Groner JA, Skybo T, Murray-Johnson L, Schwirian P, Eneli I, Sternstein A, Klein E, French G. Anticipatory guidance for prevention of childhood obesity: design of the MOMS project. Clin Pediatr (Phila). 2009 Jun;48(5):483-92. doi: 10.1177/0009922809331799. Epub 2009 Feb 25.
Results Reference
background
PubMed Identifier
21276876
Citation
Nicholson LM, Schwirian PM, Klein EG, Skybo T, Murray-Johnson L, Eneli I, Boettner B, French GM, Groner JA. Recruitment and retention strategies in longitudinal clinical studies with low-income populations. Contemp Clin Trials. 2011 May;32(3):353-62. doi: 10.1016/j.cct.2011.01.007. Epub 2011 Jan 27.
Results Reference
background
PubMed Identifier
22891225
Citation
French GM, Nicholson L, Skybo T, Klein EG, Schwirian PM, Murray-Johnson L, Sternstein A, Eneli I, Boettner B, Groner JA. An evaluation of mother-centered anticipatory guidance to reduce obesogenic infant feeding behaviors. Pediatrics. 2012 Sep;130(3):e507-17. doi: 10.1542/peds.2011-3027. Epub 2012 Aug 13.
Results Reference
derived

Learn more about this trial

Anticipatory Guidance to Prevent Childhood Obesity

We'll reach out to this number within 24 hrs