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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03713840
Other study ID # 11-07599
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 15, 2013
Est. completion date July 1, 2014

Study information

Verified date October 2018
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 154
Est. completion date July 1, 2014
Est. primary completion date July 1, 2014
Accepts healthy volunteers No
Gender All
Age group 2 Years to 5 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healthy Beverages in Child Care
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.

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary BMI% We computed age and sex specific BMI% using the Centers for Disease Control and Prevention age- and sex-specific growth curves 12 weeks
Primary Proportion obese BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained 12 weeks
Primary Proportion overweight BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained 12 weeks
Secondary SSB intake (ounces/day) Intake of sugar-sweetened beverages (SSBs) or beverages with added sugar was obtained using 24 hour recalls 12 weeks
Secondary Water intake (ounces/day) Intake of water was obtained using 24 hour recalls 12 weeks
Secondary Low fat/skim milk intake (ounces/day) Intake of low fat (1%) or skim milk was obtained using 24 hour recalls 12 weeks
Secondary 2%/whole milk intake (ounces/day) Intake of 2% or whole milk was obtained using 24 hour recalls 12 weeks
Secondary 100% fruit juice (ounces/day) Intake of 100% fruit juice was obtained using 24 hour recalls 12 weeks
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