Clinical trial NCT05356338: Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership
Official title: Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2022-05-02
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in child sugary drink serving consumption
timeFrame: from baseline to month 3
measure: Change in child sugary drink serving consumption
timeFrame: from baseline to month 6
Secondary outcomes:
measure: BevQ 15 - Children Change in Servings of Water Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in Servings of SSBs Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in total Volume of Water Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in total Volume of SSBs Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in total calories of beverages consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Servings of Water Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Servings of SSBs Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Volume of Water Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Volume of SSBs Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15-Parental Change in Calories of Beverage Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: Changes in parent knowledge
timeFrame: from baseline, month 6
measure: Changes in Parent Attitudes
timeFrame: from baseline, month 6
measure: Changes in Parent Beliefs
timeFrame: from baseline, month 6
measure: Child Weight Change
timeFrame: from baseline to month 3, from baseline to month 6
measure: Child Body Mass Index Z-Score (BMIz) Change
timeFrame: from baseline to month 3, from baseline to month 6
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kristina Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: