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

NCT04238585 | Completed

• 1 other identifier: AAAS0859
• Study Type: interventional
• Target: 291
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Infant Development

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in sugar-sweetened beverage (SSB) intake in infants

  1 month

Study Arms (3)

Negative message frames

ACTIVE COMPARATOR

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

Behavioral: Mobile messaging

Sugar content information messages

ACTIVE COMPARATOR

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

Behavioral: Mobile messaging

Attention Control-Infant Safety

PLACEBO COMPARATOR

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

Behavioral: Mobile messaging

Interventions

Mobile messaging BEHAVIORAL

Mobile health messages

Attention Control-Infant Safety; Negative message frames; Sugar content information messages

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Robert Wood Johnson Foundation: collaborator

Study Sites (1)

Columbia University

New York, New York, 10032, United States

Location

Study Officials

• Jennifer Woo Baidal, MD, MPH

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Research staff performing data collection will be blinded to the intervention arm of the participants.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: January 16, 2020
• First Posted: January 23, 2020
• Study Start: January 27, 2020
• Primary Completion: February 17, 2021
• Study Completion: February 17, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)