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

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Columbia University

Status

Completed

Conditions

Pregnancy Related
Infant Development

Treatments

Behavioral: Mobile messaging

Study type

Interventional

Funder types

Other

Identifiers

NCT04238585
AAAS0859

Details and patient eligibility

About

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.

Full 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.

Enrollment

291 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

Double Blind

291 participants in 3 patient groups, including a placebo group

Negative message frames
Active Comparator group
Description:
Participants will receive messages framed in a negative manner to avoid sugar-sweetened beverages
Treatment:
Behavioral: Mobile messaging
Sugar content information messages
Active Comparator group
Description:
Participants will receive messages framed in a positive manner to promote healthy beverage consumption
Treatment:
Behavioral: Mobile messaging
Attention Control-Infant Safety
Placebo Comparator group
Description:
Participants will receive messages with infant safety education materials-attention control group
Treatment:
Behavioral: Mobile messaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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