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

NCT ID: NCT04238585

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-27

Study Completion Date

2021-02-17

Brief Summary

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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

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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.

Conditions

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Pregnancy Related Infant Development

Keywords

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Sugar-sweetened beverages Early life nutrition First 1000 Days

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

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

Study Groups

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Negative message frames

Participants will receive messages framed in a negative manner to avoid sugar-sweetened beverages

Group Type ACTIVE_COMPARATOR

Mobile messaging

Intervention Type BEHAVIORAL

Mobile health messages

Sugar content information messages

Participants will receive messages framed in a positive manner to promote healthy beverage consumption

Group Type ACTIVE_COMPARATOR

Mobile messaging

Intervention Type BEHAVIORAL

Mobile health messages

Attention Control-Infant Safety

Participants will receive messages with infant safety education materials-attention control group

Group Type PLACEBO_COMPARATOR

Mobile messaging

Intervention Type BEHAVIORAL

Mobile health messages

Interventions

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Mobile messaging

Mobile health messages

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Columbia University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Woo Baidal

Assistant Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Woo Baidal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

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Columbia University

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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AAAS0859

Identifier Type: -

Identifier Source: org_study_id