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

Primary Purpose

Obesity, Childhood

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Obesity, Childhood

Eligibility Criteria

6 Months - 4 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wake Forest School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Intervention

Arm Description

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 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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

BevQ 15 - Children Change in Servings of Water Consumption
changes in total servings of water consumed by children
BevQ 15 - Children Change in Servings of SSBs Consumption
changes in total servings of SSBs consumed by children
BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption
changes in total servings of 100% fruit juice consumed by children
BevQ 15 - Children Change in total Volume of Water Consumption
changes in total volume of water consumed by children
BevQ 15 - Children Change in total Volume of SSBs Consumption
changes in total volume of SSBs consumed by children
BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption
changes in total volume of 100% fruit juice consumed by children
BevQ 15 - Children Change in total calories of beverages consumption
Changes in calories of beverages consumed by children
BevQ 15 -Parental Change in Servings of Water Consumption
Changes in total servings of water consumed by parents
BevQ 15 -Parental Change in Servings of SSBs Consumption
Changes in total servings of SSBs consumed by parents
BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption
Changes in total servings of 100% fruit juice consumed by parents
BevQ 15 -Parental Change in Volume of Water Consumption
changes in total volume of water consumed by parents
BevQ 15 -Parental Change in Volume of SSBs Consumption
changes in total volume of SSBs consumed by parents
BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption
changes in total volume of 100% fruit juice consumed by parents
BevQ 15-Parental Change in Calories of Beverage Consumption
changes in total beverage calories for parents
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.
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.
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.
Child Weight Change
change in child weight (kg) using Electronic Health Record (EHR) data
Child Body Mass Index Z-Score (BMIz) Change
change in child BMIz also using EHR data

Full Information

First Posted
April 27, 2022
Last Updated
April 3, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05356338
Brief Title
Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership
Acronym
WHISPER
Official Title
Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Childhood

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in child sugary drink serving consumption
Description
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
Time Frame
from baseline to month 3
Title
Change in child sugary drink serving consumption
Description
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
Time Frame
from baseline to month 6
Secondary Outcome Measure Information:
Title
BevQ 15 - Children Change in Servings of Water Consumption
Description
changes in total servings of water consumed by children
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 - Children Change in Servings of SSBs Consumption
Description
changes in total servings of SSBs consumed by children
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption
Description
changes in total servings of 100% fruit juice consumed by children
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 - Children Change in total Volume of Water Consumption
Description
changes in total volume of water consumed by children
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 - Children Change in total Volume of SSBs Consumption
Description
changes in total volume of SSBs consumed by children
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption
Description
changes in total volume of 100% fruit juice consumed by children
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 - Children Change in total calories of beverages consumption
Description
Changes in calories of beverages consumed by children
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 -Parental Change in Servings of Water Consumption
Description
Changes in total servings of water consumed by parents
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 -Parental Change in Servings of SSBs Consumption
Description
Changes in total servings of SSBs consumed by parents
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption
Description
Changes in total servings of 100% fruit juice consumed by parents
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 -Parental Change in Volume of Water Consumption
Description
changes in total volume of water consumed by parents
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 -Parental Change in Volume of SSBs Consumption
Description
changes in total volume of SSBs consumed by parents
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption
Description
changes in total volume of 100% fruit juice consumed by parents
Time Frame
from baseline to month 3, from baseline to month 6
Title
BevQ 15-Parental Change in Calories of Beverage Consumption
Description
changes in total beverage calories for parents
Time Frame
from baseline to month 3, from baseline to month 6
Title
Changes in parent knowledge
Description
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.
Time Frame
from baseline, month 6
Title
Changes in Parent Attitudes
Description
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.
Time Frame
from baseline, month 6
Title
Changes in Parent Beliefs
Description
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.
Time Frame
from baseline, month 6
Title
Child Weight Change
Description
change in child weight (kg) using Electronic Health Record (EHR) data
Time Frame
from baseline to month 3, from baseline to month 6
Title
Child Body Mass Index Z-Score (BMIz) Change
Description
change in child BMIz also using EHR data
Time Frame
from baseline to month 3, from baseline to month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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