Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership
- Conditions
- Obesity, Childhood
- Registration Number
- NCT05356338
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in child sugary drink serving consumption from baseline to month 6 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 Outcome Measures
Name Time Method 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 - 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 -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 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
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 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 -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 -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
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.
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
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
Trial Locations
- Locations (1)
Wake Forest School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
Wake Forest School of Medicine🇺🇸Winston-Salem, North Carolina, United States