- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03713840
Community Partnering to Encourage Healthy Beverage Intake Through Child Care
October 18, 2018 updated by: Anisha Patel, University of California, San Francisco
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Actual)
154
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94118
- University of California, San Francisco
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 5 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy Beverages in Child Care
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.
|
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.
|
No Intervention: Control
Child care centers in the control arm received access to intervention materials at a later date.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
BMI (kg/m2)
Time Frame: 12 weeks
|
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%
Time Frame: 12 weeks
|
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
Time Frame: 12 weeks
|
BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained
|
12 weeks
|
Proportion overweight
Time Frame: 12 weeks
|
BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SSB intake (ounces/day)
Time Frame: 12 weeks
|
Intake of sugar-sweetened beverages (SSBs) or beverages with added sugar was obtained using 24 hour recalls
|
12 weeks
|
Water intake (ounces/day)
Time Frame: 12 weeks
|
Intake of water was obtained using 24 hour recalls
|
12 weeks
|
Low fat/skim milk intake (ounces/day)
Time Frame: 12 weeks
|
Intake of low fat (1%) or skim milk was obtained using 24 hour recalls
|
12 weeks
|
2%/whole milk intake (ounces/day)
Time Frame: 12 weeks
|
Intake of 2% or whole milk was obtained using 24 hour recalls
|
12 weeks
|
100% fruit juice (ounces/day)
Time Frame: 12 weeks
|
Intake of 100% fruit juice was obtained using 24 hour recalls
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Anisha Patel, MD, MSPH, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
July 1, 2014
Study Registration Dates
First Submitted
October 17, 2018
First Submitted That Met QC Criteria
October 18, 2018
First Posted (Actual)
October 22, 2018
Study Record Updates
Last Update Posted (Actual)
October 22, 2018
Last Update Submitted That Met QC Criteria
October 18, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-07599
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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