Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership

Obesity, Childhood Clinical Trial

— WHISPER  

Official title:

Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05356338
• Other study ID #: IRB00073800
• Status: Completed
• Phase: N/A
• Start date: May 25, 2022
• Est. completion date: September 19, 2023

Study information

• Verified date: April 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 19, 2023
• Est. primary completion date: September 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Pilot 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

Locations

Country	Name	City	State
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in child sugary drink serving consumption	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	from baseline to month 3
Primary	Change in child sugary drink serving consumption	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	from baseline to month 6
Secondary	BevQ 15 - Children Change in Servings of Water Consumption	changes in total servings of water consumed by children	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 - Children Change in Servings of SSBs Consumption	changes in total servings of SSBs consumed by children	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption	changes in total servings of 100% fruit juice consumed by children	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 - Children Change in total Volume of Water Consumption	changes in total volume of water consumed by children	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 - Children Change in total Volume of SSBs Consumption	changes in total volume of SSBs consumed by children	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption	changes in total volume of 100% fruit juice consumed by children	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 - Children Change in total calories of beverages consumption	Changes in calories of beverages consumed by children	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Servings of Water Consumption	Changes in total servings of water consumed by parents	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Servings of SSBs Consumption	Changes in total servings of SSBs consumed by parents	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption	Changes in total servings of 100% fruit juice consumed by parents	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Volume of Water Consumption	changes in total volume of water consumed by parents	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Volume of SSBs Consumption	changes in total volume of SSBs consumed by parents	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption	changes in total volume of 100% fruit juice consumed by parents	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15-Parental Change in Calories of Beverage Consumption	changes in total beverage calories for parents	from baseline to month 3, from baseline to month 6
Secondary	Changes in parent knowledge	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.	from baseline, month 6
Secondary	Changes in Parent Attitudes	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.	from baseline, month 6
Secondary	Changes in Parent Beliefs	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.	from baseline, month 6
Secondary	Child Weight Change	change in child weight (kg) using Electronic Health Record (EHR) data	from baseline to month 3, from baseline to month 6
Secondary	Child Body Mass Index Z-Score (BMIz) Change	change in child BMIz also using EHR data	from baseline to month 3, from baseline to month 6