Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families

Not Applicable

Completed

• Conditions: Obesity, Childhood

• Registration Number: NCT04886817
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.

Detailed Description

This is a pilot 2-arm randomized trial among 60 families of 1-8 year old children 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 an educational video, water promotion toolkit, mobile phone app, and series of educational phone calls, 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 Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-13
• Study First Posted: 2021-05-14
• Study Start: 2021-06-17
• Primary Completion: 2021-11-18
• Study Completion: 2021-11-18
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Child 1-8 years old who receives health care attention at Wake Forest pediatric or family medicine practices
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in child sugary drink serving consumption	from baseline to month 6	change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument

Secondary Outcome Measures

Name	Time	Method
BevQ 15-Parental Change in Calories of Beverage Consumption	from baseline to month 3, from baseline to month 6	changes in total beverage calories for parents including water and unsweetened milk
Changes in parent knowledge	from baseline to month 3, from baseline to month 6	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, including how SSB are related to possible health consequences and perceived healthfulness of different beverages.
BevQ 15 - Children Change in Servings of Beverages	from baseline to month 3, from baseline to month 6	changes in total servings children including water and unsweetened milk
BevQ 15 - Children Change in total Volume of Beverages	from baseline to month 3, from baseline to month 6	changes in total volume of beverages consumed by children including water and unsweetened milk
BevQ 15 - Children Change in total calories of beverages consumption	from baseline to month 3, from baseline to month 6	Changes in calories of beverages consumed by children including water and unsweetened milk
BevQ 15 -Parental Change in Beverage Consumption	from baseline to month 3, from baseline to month 6	changes in total servings for parents including water and unsweetened milk
Changes in Parent Attitudes	from baseline to month 3, from baseline to month 6	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.
Child Body Mass Index Z-Score (BMIz) Change	from baseline to month 3, from baseline to month 6	change in child BMIz also using EHR data
BevQ 15 -Parental Change in Volume of Beverage Consumption	from baseline to month 3, from baseline to month 6	changes in total volume for parents including water and unsweetened milk
Changes in Parent Beliefs	from baseline to month 3, from baseline to month 6	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	from baseline to month 3, from baseline to month 6	change in child weight (kg) using Electronic Health Record (EHR) data
BevQ 15 -Parental Change in Sugary beverage consumption	from baseline to month 3, from baseline to month 6	changes in parental beverage consumption sugary drink serving

Trial Locations

Locations (1)

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States