ObesityNCT03713840
Community Partnering to Encourage Healthy Beverage Intake Through Child Care
A study testing Healthy Beverages in Child Care in people with Obesity, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Obesity
- What is being tested?
- Healthy Beverages in Child Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2013to 1 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Non-center, unlicensed, and higher-income child care facilities were ineligible to participate.
- Parents unable to speak Spanish/English were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94118
About this study
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.
Read the 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).
- Conditions
- Obesity
- Being tested
- Healthy Beverages in Child Care
- Keywords
- nutrition, child care, obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Beverages in Child CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
BMI%
We computed age and sex specific BMI% using the Centers for Disease Control and Prevention age- and sex-specific growth curves
Measured: 12 weeks
Proportion obese
BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained
Measured: 12 weeks
Proportion overweight
BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained
Measured: 12 weeks
Secondary outcomes (5)
SSB intake (ounces/day)
Intake of sugar-sweetened beverages (SSBs) or beverages with added sugar was obtained using 24 hour recalls
Measured: 12 weeks
Water intake (ounces/day)
Intake of water was obtained using 24 hour recalls
Measured: 12 weeks
Low fat/skim milk intake (ounces/day)
Intake of low fat (1%) or skim milk was obtained using 24 hour recalls
Measured: 12 weeks
2%/whole milk intake (ounces/day)
Intake of 2% or whole milk was obtained using 24 hour recalls
Measured: 12 weeks
100% fruit juice (ounces/day)
Intake of 100% fruit juice was obtained using 24 hour recalls
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start15 Aug 2013
- Primary completion1 Jul 2014
- Study completion1 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anisha Patel, University of California, San Francisco
- Investigators
- Anisha Patel, MD, MSPH, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03713840
- Sponsor's protocol ID
- 11-07599
- Status last verified
- Oct 2018
- First submitted
- 17 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Partnering to Encourage Healthy Beverage Intake Through Child Care
- ClinicalTrials.gov ID
- NCT03713840
- Acronym / sponsor ID
- 11-07599
- Conditions
- Obesity
- Keywords
- nutrition, child care, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Aug 2013 (actual)
- Primary completion
- 1 Jul 2014 (actual)
- Study completion
- 1 Jul 2014 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Beverages in Child Care | Experimental | Behavioral: Healthy Beverages in Child CareChild 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. |
| Control | No intervention | –Child care centers in the control arm received access to intervention materials at a later date. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Non-center, unlicensed, and higher-income child care facilities were ineligible to participate.
- Parents unable to speak Spanish/English were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Beverages in Child Care12-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. | Behavioural | Healthy Beverages in Child Care |
Primary outcome
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.
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
Proportion obese
Time frame: 12 weeks
BMI% greater than or equal to 95% comprised obesity; The proportion of children meeting that definition was obtained
Proportion overweight
Time frame: 12 weeks
BMI% greater than or equal to 85% comprised obesity; The proportion of children meeting that definition was obtained
5 secondary outcomes
SSB intake (ounces/day)
Time frame: 12 weeks
Water intake (ounces/day)
Time frame: 12 weeks
Low fat/skim milk intake (ounces/day)
Time frame: 12 weeks
2%/whole milk intake (ounces/day)
Time frame: 12 weeks
100% fruit juice (ounces/day)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anisha Patel, MD, MSPH principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Beverages in Child Care in people with Obesity, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMI (kg/m2) (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2018.