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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04238585
Enrollment
291
Registered
2020-01-23
Start date
2020-01-27
Completion date
2021-02-17
Last updated
2021-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant Development, Pregnancy Related

Keywords

Sugar-sweetened beverages, Early life nutrition, First 1000 Days

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.

Interventions

BEHAVIORALMobile messaging

Mobile health messages

Sponsors

Robert Wood Johnson Foundation
CollaboratorOTHER
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Investigator)

Masking description

Research staff performing data collection will be blinded to the intervention arm of the participants.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in sugar-sweetened beverage (SSB) intake in kcals among adult participants1 monthDetermine change from baseline to follow-up in habitual daily caloric intake of SSBs using parent self report of beverage intake

Secondary

MeasureTime frameDescription
Change in sugar-sweetened beverage (SSB) intake in infants1 monthDetermine 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026