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Clinical Trials/NCT04238585
NCT04238585
Completed
Not Applicable

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

Columbia University1 site in 1 country291 target enrollmentJanuary 27, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pregnancy Related
Sponsor
Columbia University
Enrollment
291
Locations
1
Primary Endpoint
Change in sugar-sweetened beverage (SSB) intake in kcals among adult participants
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 27, 2020
End Date
February 17, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jennifer Woo Baidal

Assistant Professor of Pediatrics

Columbia University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in sugar-sweetened beverage (SSB) intake in kcals among adult participants

Time Frame: 1 month

Determine change from baseline to follow-up in habitual daily caloric intake of SSBs using parent self report of beverage intake

Secondary Outcomes

  • Change in sugar-sweetened beverage (SSB) intake in infants(1 month)

Study Sites (1)

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