Clinical trial NCT04238585: BabyQ's: Randomized Controlled Trial of Health Messaging in Pregnancy and Infancy
Official title: Intervening to Promote Healthy Weight From Gestation to Age 2, Particularly Among Disproportionately Burdened Populations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Infant Development
Keywords: Sugar-sweetened beverages
Early life nutrition
First 1000 Days
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2020-01-23
Enrollment: 291
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Families who present for a routine WIC visit will be referred for study staff recruitment if they meet either of the following criteria: 1) pregnant woman or 2) parent of child \<24 months enrolled in WIC.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in sugar-sweetened beverage (SSB) intake in kcals among adult participants
timeFrame: 1 month
Secondary outcomes:
measure: Change in sugar-sweetened beverage (SSB) intake in infants
timeFrame: 1 month
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Jennifer Woo Baidal, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: