Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership
- Conditions
- Obesity, Childhood
- Interventions
- Behavioral: Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC
- 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
- Arm && Interventions
Group Intervention Description Intervention Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC Intervention participants will receive a 6-month behavioral intervention with the following components: A water promotion toolkit that includes water bottles, water flavor infusers, stickers to decorate bottles, children's book about water consumption, and instructions for other intervention components (how to view videos, download app, and prepare for calls) Two brief educational videos: a 5-minute video about healthy drink choices for the family and a 3-min video educating residents about local water. Ready, Set Gulp! app for families that will help all family members track their beverage intake, find out how much water and sugar they are consuming, set goals, compete for points, answer quiz questions and create new recipes for flavor infused water. A series of 14 interactive voice response phone calls to parents over 6 months that educate parents on topics relevant to improving family drink choices. Two counseling sessions by a WIC nutritionist at months 2 and 4
- 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