Anticipatory Guidance to Prevent Childhood Obesity

Childhood Obesity Clinical Trial

— MOMS  

Official title:

Can Changing How Moms Eat Prevent Obesity in Toddlers?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565525
• Other study ID #: HD50944
• Status: Completed
• Phase: N/A
• First received: March 26, 2012
• Last updated: March 27, 2012
• Start date: June 2005
• Est. completion date: July 2007

Study information

• Verified date: March 2012
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 2 Months

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Intervention

Behavioral:
• Maternal focused intervention
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.
• Ounce of Prevention
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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year after study entry	No
Secondary	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.	One year after study entry.	No