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Community Partnering to Encourage Healthy Beverage Intake Through Child Care

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Healthy Beverages in Child Care
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity focused on measuring nutrition, child care, obesity

Eligibility Criteria

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Two to five-year-old children were eligible if they were enrolled in participating child care facilities.
  3. Parents of eligible children were able to participate in beverage intake surveys if they spoke English or Spanish.

Exclusion Criteria:

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Healthy Beverages in Child Care

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
BMI%
We computed age and sex specific BMI% using the Centers for Disease Control and Prevention age- and sex-specific growth curves
Proportion obese
BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained
Proportion overweight
BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained

Secondary Outcome Measures

SSB intake (ounces/day)
Intake of sugar-sweetened beverages (SSBs) or beverages with added sugar was obtained using 24 hour recalls
Water intake (ounces/day)
Intake of water was obtained using 24 hour recalls
Low fat/skim milk intake (ounces/day)
Intake of low fat (1%) or skim milk was obtained using 24 hour recalls
2%/whole milk intake (ounces/day)
Intake of 2% or whole milk was obtained using 24 hour recalls
100% fruit juice (ounces/day)
Intake of 100% fruit juice was obtained using 24 hour recalls

Full Information

First Posted
October 17, 2018
Last Updated
October 18, 2018
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT03713840
Brief Title
Community Partnering to Encourage Healthy Beverage Intake Through Child Care
Official Title
Community Partnering to Encourage Healthy Beverage Intake Through Child Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 15, 2013 (Actual)
Primary Completion Date
July 1, 2014 (Actual)
Study Completion Date
July 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Inappropriate intake of whole milk, fruit juice, and sugar-sweetened beverages is associated with childhood obesity, obesity-related co morbidities, and dental caries, yet there are few proven interventions to promote child intake of healthy beverages consistent with national guidelines. Child care facilities provide a potential venue for influencing healthy beverage intake in children and families. The overall objective of this study is to use principles of community-based participatory research (CBPR; an approach in which researchers partner with community members to conduct research) to develop, pilot test, and examine the acceptability, feasibility, sustainability, and preliminary outcomes of a child care-based intervention to encourage child intake of age-appropriate, guideline-recommended beverages. The central hypothesis is that a multi-level intervention consisting of educational strategies to encourage intake of guideline-recommended beverages; increased accessibility of lead-free, fluoridated, drinking water in child care and at home; and evidence-based child care and home beverage policies will lead to healthier beverage intake and reduced childhood obesity. This hypothesis was tested through a quasi-experimental trial in four child care centers. Centers were randomized to a control (delayed-intervention) condition or to receive a 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. Outcomes were measured at baseline and immediately post-intervention and included children's (n =154) at-home beverage consumption (assessed via parental report) and overweight/obese weight status (assessed via objectively measured height and weight).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
nutrition, child care, obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy Beverages in Child Care
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Child care centers in the control arm received access to intervention materials at a later date.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Beverages in Child Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI (kg/m2)
Description
Height and weight measurements were obtained per NHANES anthropometry procedures manual. Weight in kilograms was divided by height in meters squared to obtain BMI.
Time Frame
12 weeks
Title
BMI%
Description
We computed age and sex specific BMI% using the Centers for Disease Control and Prevention age- and sex-specific growth curves
Time Frame
12 weeks
Title
Proportion obese
Description
BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained
Time Frame
12 weeks
Title
Proportion overweight
Description
BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
SSB intake (ounces/day)
Description
Intake of sugar-sweetened beverages (SSBs) or beverages with added sugar was obtained using 24 hour recalls
Time Frame
12 weeks
Title
Water intake (ounces/day)
Description
Intake of water was obtained using 24 hour recalls
Time Frame
12 weeks
Title
Low fat/skim milk intake (ounces/day)
Description
Intake of low fat (1%) or skim milk was obtained using 24 hour recalls
Time Frame
12 weeks
Title
2%/whole milk intake (ounces/day)
Description
Intake of 2% or whole milk was obtained using 24 hour recalls
Time Frame
12 weeks
Title
100% fruit juice (ounces/day)
Description
Intake of 100% fruit juice was obtained using 24 hour recalls
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Non-center, unlicensed, and higher-income child care facilities were ineligible to participate. Parents unable to speak Spanish/English were excluded.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anisha Patel, MD, MSPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Community Partnering to Encourage Healthy Beverage Intake Through Child Care

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