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

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Related; Infant Development
• Intervention / Treatment: Behavioral: Mobile messaging

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.

• Study Type: Interventional
• Enrollment (Actual): 291
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: Robert Wood Johnson Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2020
• Primary Completion (Actual): February 17, 2021
• Study Completion (Actual): February 17, 2021

Study Registration Dates

• First Submitted: January 16, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 23, 2020

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Sugar-sweetened beverages; Early life nutrition; First 1000 Days
• Other Study ID Numbers: AAAS0859

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No