Community Partnering to Encourage Healthy Beverage Intake Through Child Care

• ClinicalTrials.gov Identifier: NCT03713840
• Recruitment Status: Completed
• First Posted: October 22, 2018
• Last Update Posted: October 22, 2018
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): Anisha Patel, University of California, San Francisco

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.

Condition or disease	Intervention/treatment	Phase
Obesity	Behavioral: Healthy Beverages in Child Care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 154 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Community Partnering to Encourage Healthy Beverage Intake Through Child Care
• Actual Study Start Date: August 15, 2013
• Actual Primary Completion Date: July 1, 2014
• Actual Study Completion Date: July 1, 2014

Arms and Interventions

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.	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.
No Intervention: Control; Child care centers in the control arm received access to intervention materials at a later date.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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
3. Proportion obese [ Time Frame: 12 weeks ]
   BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained
4. Proportion overweight [ Time Frame: 12 weeks ]
   BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained

Secondary Outcome Measures :

1. 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
2. Water intake (ounces/day) [ Time Frame: 12 weeks ]
   Intake of water was obtained using 24 hour recalls
3. 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
4. 2%/whole milk intake (ounces/day) [ Time Frame: 12 weeks ]
   Intake of 2% or whole milk was obtained using 24 hour recalls
5. 100% fruit juice (ounces/day) [ Time Frame: 12 weeks ]
   Intake of 100% fruit juice was obtained using 24 hour recalls

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 5 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, California

University of California, San Francisco

San Francisco, California, United States, 94118

Sponsors and Collaborators

University of California, San Francisco

Investigators

• Principal Investigator: Anisha Patel, MD, MSPH; University of California, San Francisco

More Information

• Responsible Party: Anisha Patel, Associate Professor, University of California, San Francisco
• ClinicalTrials.gov Identifier: NCT03713840
• Other Study ID Numbers: 11-07599
• First Posted: October 22, 2018
• Last Update Posted: October 22, 2018
• Last Verified: October 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Anisha Patel, University of California, San Francisco:

nutrition; child care; obesity

Additional relevant MeSH terms:

Obesity; Overnutrition; Nutrition Disorders; Overweight; Body Weight