BabyQ's: Randomized Controlled Trial of Health Messaging in Pregnancy and Infancy

Pregnancy Related Clinical Trial

Official title:

Intervening to Promote Healthy Weight From Gestation to Age 2, Particularly Among Disproportionately Burdened Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238585
• Other study ID #: AAAS0859
• Status: Completed
• Phase: N/A
• Start date: January 27, 2020
• Est. completion date: February 17, 2021

Study information

• Verified date: November 2021
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized controlled intervention evaluates the effect of a mobile health behavioral intervention to test messages to reduce sugar-sweetened beverage intake during pregnancy and infancy.

The study team will perform a prospective, longitudinal, interventional, randomized control trial by recruiting 300 WIC families during the first 1,000 days of life (pregnancy through infant age 2 months) at consecutive Women, Infants, and Children (WIC) visits to test two interventions compared to a control group. The study team will implement a mobile-based messaging intervention allocate participants to one of 3 arms for a 1 month period: 1) negative message frames, 2) positive message frames, and 3) attention control.

Description:

Childhood obesity prevalence soared over the past four decades with a 10-fold increase globally from 1975-2015 and Healthy People 2020 has declared obesity a national health priority. Socioeconomic and racial/ethnic disparities in obesity exist and may be widening. These disparities are apparent by age 2 years with recent national data showing that Hispanic children continue to have highest obesity prevalence (15.6%) and on-Hispanic black children have 2-fold higher obesity prevalence (10.4%) compared to non-Hispanic white (5.2%) counterparts. The first 1,000 days describes the period from pregnancy through child age 2 years, and is increasingly recognized as a critical period for development of childhood obesity and its adverse consequences. Several risk factors are consistently associated with later childhood obesity during the first 1,000 days and are more prevalent among low socioeconomic groups and racial/ethnic minorities. These modifiable risk factors mediate the development of racial/ethnic disparities in later childhood obesity.

Sugar-sweetened beverage (SSB) consumption during the first 1,000 days is a risk factor for childhood overweight/obesity, and has been linked to dental caries, lower child cognition, and the adverse child health consequences. Recent evidence shows that maternal SSB consumption during pregnancy and infant SSB consumption in the first year of life are associated with childhood obesity later in life. Thus, interventions to curb SSB consumption and promote healthy beverage intake in urban, low-income Hispanic/Latino families must start early in life, yet few SSB-specific interventions have ventured to do so.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 291
• Est. completion date: February 17, 2021
• Est. primary completion date: February 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Pregnant women age 18 years or older or; legal caretakers of infants under 24 months enrolled in WIC

• Can respond to questions in English or Spanish

• Report use of a mobile device using iOS or Android

• Give permission to enroll in messaging system

Exclusion Criteria:

• Pregnant women with chronic medical conditions that may impact their nutrition behaviors

• Families whose eligible child has chronic conditions that interest with growth or feeding

Related Conditions & MeSH terms

• Infant Development
• Pregnancy Related

Intervention

Behavioral:
• Mobile messaging
Mobile health messages

Locations

Country	Name	City	State
United States	Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sugar-sweetened beverage (SSB) intake in kcals among adult participants	Determine change from baseline to follow-up in habitual daily caloric intake of SSBs using parent self report of beverage intake	1 month
Secondary	Change in sugar-sweetened beverage (SSB) intake in infants	Determine change from baseline to follow-up in parent-reported infant SSB intake using logistic regression to examine a categorical outcome (any infant SSB consumption v. none)	1 month