NCT03713840

Brief Summary

Beverage consumption is an important determinant of young children's weight, yet few obesity prevention interventions focus comprehensively on encouraging healthy beverage consumption. This quasi-experimental study evaluated whether a childcare-based intervention, combining environmental changes, education/promotion, and policy supports to promote healthy beverage intake, improved at-home beverage consumption and weight status among children ages 2-5 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
154

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Aug 2013

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

October 17, 2018

Last Update Submit

October 18, 2018

Conditions

Keywords

nutritionchild careobesity

Outcome Measures

Primary Outcomes (4)

  • BMI (kg/m2)

    Height and weight measurements were obtained per NHANES anthropometry procedures manual. Weight in kilograms was divided by height in meters squared to obtain BMI.

    12 weeks

  • BMI%

    We computed age and sex specific BMI% using the Centers for Disease Control and Prevention age- and sex-specific growth curves

    12 weeks

  • Proportion obese

    BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained

    12 weeks

  • Proportion overweight

    BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained

    12 weeks

Secondary Outcomes (5)

  • SSB intake (ounces/day)

    12 weeks

  • Water intake (ounces/day)

    12 weeks

  • Low fat/skim milk intake (ounces/day)

    12 weeks

  • 2%/whole milk intake (ounces/day)

    12 weeks

  • 100% fruit juice (ounces/day)

    12 weeks

Study Arms (2)

Healthy Beverages in Child Care

EXPERIMENTAL

Child care centers in the experimental arm received 12-week intervention that promoted consumption of healthy beverages (water, unsweetened low-fat milk) and discouraged consumption of unhealthy beverages (juice, sugar-sweetened beverages, high-fat or sweetened milk). The multi-pronged intervention was delivered via child care centers, targeted children, parents, and child care staff, and included education, environmental changes, and policies.

Behavioral: Healthy Beverages in Child Care

Control

NO INTERVENTION

Child care centers in the control arm received access to intervention materials at a later date.

Interventions

12-week intervention promoted consumption of healthy beverages (water, unsweetened low-fat milk) and discouraged consumption of unhealthy beverages (juice, sugar-sweetened beverages, high-fat or sweetened milk). The multi-pronged intervention was delivered via child care centers, targeted children, parents, and child care staff, and included education, environmental changes, and policies.

Healthy Beverages in Child Care

Eligibility Criteria

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Child care centers were eligible if they were in San Mateo County, CA, were licensed, had enrolled at least ten children ages 2-5 years, participated in the Child and Adult Care Food Program (CACFP: a federal nutrition assistance program providing funding for meals and snacks), had English or Spanish-speaking staff, and served primarily English or Spanish-speaking families.
  • Two to five-year-old children were eligible if they were enrolled in participating child care facilities.
  • Parents of eligible children were able to participate in beverage intake surveys if they spoke English or Spanish.

You may not qualify if:

  • Non-center, unlicensed, and higher-income child care facilities were ineligible to participate.
  • Parents unable to speak Spanish/English were excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94118, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Child Care

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Anisha Patel, MD, MSPH

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 22, 2018

Study Start

August 15, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 22, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations