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

Wake Forest University Health Sciences20 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Obesity, Childhood

Interventions

Pilot Intervention to reduce SSB consumption in children and families enrolled in WICBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 4 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Outcomes

Primary Outcomes

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

Time frame: from baseline to month 3

Change in child sugary drink serving consumption

Time frame: from baseline to month 6

Secondary Outcomes

BevQ 15 - Children Change in Servings of Water Consumption

changes in total servings of water consumed by children

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 - Children Change in Servings of SSBs Consumption

changes in total servings of SSBs consumed by children

Time frame: from baseline to month 3, from baseline to month 6

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

changes in total servings of 100% fruit juice consumed by children

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 - Children Change in total Volume of Water Consumption

changes in total volume of water consumed by children

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 - Children Change in total Volume of SSBs Consumption

Data from ClinicalTrials.gov

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changes in total volume of SSBs consumed by children

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption

changes in total volume of 100% fruit juice consumed by children

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 - Children Change in total calories of beverages consumption

Changes in calories of beverages consumed by children

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 -Parental Change in Servings of Water Consumption

Changes in total servings of water consumed by parents

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 -Parental Change in Servings of SSBs Consumption

Changes in total servings of SSBs consumed by parents

Time frame: from baseline to month 3, from baseline to month 6

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

Changes in total servings of 100% fruit juice consumed by parents

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 -Parental Change in Volume of Water Consumption

changes in total volume of water consumed by parents

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 -Parental Change in Volume of SSBs Consumption

changes in total volume of SSBs consumed by parents

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption

changes in total volume of 100% fruit juice consumed by parents

Time frame: from baseline to month 3, from baseline to month 6

BevQ 15-Parental Change in Calories of Beverage Consumption

changes in total beverage calories for parents

Time frame: from baseline to month 3, from baseline to month 6

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.

Time frame: from baseline, month 6

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.

Time frame: from baseline, month 6

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.

Time frame: from baseline, month 6

Child Weight Change

change in child weight (kg) using Electronic Health Record (EHR) data

Time frame: from baseline to month 3, from baseline to month 6

Child Body Mass Index Z-Score (BMIz) Change

change in child BMIz also using EHR data

Time frame: from baseline to month 3, from baseline to month 6