Obesity, Childhood
Conditions
Brief summary
Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.
Detailed description
This is a pilot 2-arm randomized trial among 30 WIC enrolled families of children 6 months through 4 years old who currently over-consume sugary drinks. The study team will randomize families to either an intervention group, that will receive a behavioral intervention consisting of two educational videos, a water promotion toolkit, mobile phone app, series of educational phone calls and extra counseling from WIC nutritionists, or to a control group that will not receive this intervention. The study team will compare 6-month change in child and parental beverage consumption between groups. Exploratory analyses will examine child weight (kg) and Body Mass Index (BMI) z-score (BMIz) outcomes, and compare intervention effects across race/ethnic groups.
Interventions
BEHAVIORALPilot Intervention to reduce SSB consumption in children and families enrolled in WIC
A 6-month intervention based on the use of 5 components: 2 educational videos, provision of a water-promotion toolkit, a mobile phone application (app), a series of 14 computerized interactive voice response (IVR) phone calls to parents and 2 counseling sessions by a WIC nutritionist to compare families' SSB's consumption behaviors
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Study staff collecting data on the primary outcome of beverage consumption at 3 and 6 month follow-up will be blinded to group allocation of participants.
Eligibility
Sex/Gender
ALL
Age
6 Months to 4 Years
Healthy volunteers
Yes
Inclusion criteria
* Child 6 months - 4 years old who receives health care attention at Wake Forest pediatric or family medicine practices * Child enrolled in WIC * Child consumes 2 or more SSB and/or fruit juice total per day * Child with no chronic health condition * Child has not seen nutritionist or visited our family-based weight management clinic in the past year * Parent/caregiver who has not watch educational video Get in the Zero Zone * Parent/caregiver has a smartphone and reliable internet * Parent/caregiver able to communicate well in English
Exclusion criteria
* Child doesn't meet age criteria * Child consumes less than 2 SSB and/or fruit juice total per day * Child with a chronic health condition * Child has seen nutritionist or visited our family-based weight management clinic in the past year * Parent/caregiver has watched educational video Get in the Zero Zone * Parent/caregiver has completed interview or usability test * Parent/caregiver doesn't have a smartphone or reliable internet * Parent/caregiver not able to communicate well in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in child sugary drink serving consumption | from baseline to month 3 | change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BevQ 15 - Children Change in Servings of SSBs Consumption | from baseline to month 3, from baseline to month 6 | changes in total servings of SSBs consumed by children |
| BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption | from baseline to month 3, from baseline to month 6 | changes in total servings of 100% fruit juice consumed by children |
| BevQ 15 - Children Change in total Volume of Water Consumption | from baseline to month 3, from baseline to month 6 | changes in total volume of water consumed by children |
| BevQ 15 - Children Change in total Volume of SSBs Consumption | from baseline to month 3, from baseline to month 6 | changes in total volume of SSBs consumed by children |
| BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption | from baseline to month 3, from baseline to month 6 | changes in total volume of 100% fruit juice consumed by children |
| BevQ 15 - Children Change in total calories of beverages consumption | from baseline to month 3, from baseline to month 6 | Changes in calories of beverages consumed by children |
| BevQ 15 -Parental Change in Servings of Water Consumption | from baseline to month 3, from baseline to month 6 | Changes in total servings of water consumed by parents |
| BevQ 15 -Parental Change in Servings of SSBs Consumption | from baseline to month 3, from baseline to month 6 | Changes in total servings of SSBs consumed by parents |
| BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption | from baseline to month 3, from baseline to month 6 | Changes in total servings of 100% fruit juice consumed by parents |
| BevQ 15 - Children Change in Servings of Water Consumption | from baseline to month 3, from baseline to month 6 | changes in total servings of water consumed by children |
| BevQ 15 -Parental Change in Volume of SSBs Consumption | from baseline to month 3, from baseline to month 6 | changes in total volume of SSBs consumed by parents |
| BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption | from baseline to month 3, from baseline to month 6 | changes in total volume of 100% fruit juice consumed by parents |
| BevQ 15-Parental Change in Calories of Beverage Consumption | from baseline to month 3, from baseline to month 6 | changes in total beverage calories for parents |
| Changes in parent knowledge | from baseline, month 6 | Survey knowledge items will be scored in terms of correct or not with a range of 0-17 possible points, with higher score demonstrating more knowledge about SSB and FJ. |
| Changes in Parent Attitudes | from baseline, month 6 | Attitude and belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data. |
| Changes in Parent Beliefs | from baseline, month 6 | Belief items will be reported individually, as these are not objectively correct or incorrect and represent a subjective state of the parent's point of view. These will be reported out as frequencies / descriptive statistics, with change in proportion responding a certain way examined over follow-up. Statistician will use Statistical Analysis Software (SAS) for quantifying qualitative data. |
| Child Weight Change | from baseline to month 3, from baseline to month 6 | change in child weight (kg) using Electronic Health Record (EHR) data |
| Child Body Mass Index Z-Score (BMIz) Change | from baseline to month 3, from baseline to month 6 | change in child BMIz also using EHR data |
| BevQ 15 -Parental Change in Volume of Water Consumption | from baseline to month 3, from baseline to month 6 | changes in total volume of water consumed by parents |
Countries
United States
Outcome results
None listed