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

NCT05356338 | Completed

• 1 other identifier: IRB00073800
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (19)

• BevQ 15 - Children Change in Servings of Water Consumption

  from baseline to month 3, from baseline to month 6

• BevQ 15 - Children Change in Servings of SSBs Consumption

  from baseline to month 3, from baseline to month 6

• BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption

  from baseline to month 3, from baseline to month 6

• BevQ 15 - Children Change in total Volume of Water Consumption

  from baseline to month 3, from baseline to month 6

• BevQ 15 - Children Change in total Volume of SSBs Consumption

  from baseline to month 3, from baseline to month 6

Study Arms (2)

Control

NO INTERVENTION

The control group participants in this study will not receive any intervention as is the current standard of clinical care for excess sugary drink consumption. They will receive monthly check-in reminders from research staff to promote engagement and retention and will participate in data collection visits at baseline, 3 and 6 months.

Intervention

EXPERIMENTAL

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

Behavioral: Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC

Interventions

Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 6 Months - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina Lewis, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 2, 2022
• Study Start: May 25, 2022
• Primary Completion: September 19, 2023
• Study Completion: September 19, 2023
• Last Updated: February 13, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)