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

Obesity, Childhood Clinical Trial

— SCOPE-IT  

Official title:

A Health Systems Intervention to Reduce Sugar-Sweetened Beverage Consumption in Young Children and Families

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04886817
• Other study ID #: IRB00062659
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: November 18, 2021

Study information

• Verified date: May 2021
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: November 18, 2021
• Est. primary completion date: November 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

Behavioral:
• Pilot Intervention to reduce SSB consumption in children and families
A 6-month intervention based on the use of 4 components: an educational video, provision of a water-promotion "toolkit," a mobile phone application (app), and a series of 14 computerized interactive voice response (IVR) phone calls to parents 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
Other	Single Item Literacy Screener (SILS)	The SILS is a single item question intended to identify adults in need of help with printed health material. The SILS asks, "How often do you need to have someone help you when you read instructions, pamphlets, or other written material from your doctor or pharmacy?" Possible responses are 1-Never, 2-Rarely, 3-Sometimes, 4-Often, and 5-Always	baseline
Other	Modified Version of the Mobile Device Proficiency Questionnaire (MDPQ)	This questionnaire asks about the ability to perform a number of tasks with a mobile device. The MDPQ asks seniors to select how easily they could perform 19 mobile device skills from Not at all, Not very easily, Somewhat easily, or very easily.	baseline
Other	NCI's 26-item Dietary Screener Questionnaire (DSQ)	The study team will use only 19 items of the DSQ to assess intake of fruits and vegetables, whole grains, added sugars, dairy, fiber, and calcium. DSQ will be asked of parent, responding for child and will exclude questions about beverages as those would be redundant to questions already included in the Bevq-15 instrument.	baseline, month 6
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 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 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 Beverages	changes in total servings children including water and unsweetened milk	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 - Children Change in total Volume of Beverages	changes in total volume of beverages consumed by children including water and unsweetened milk	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 including water and unsweetened milk	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Sugary beverage consumption	changes in parental beverage consumption sugary drink serving	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Beverage Consumption	changes in total servings for parents including water and unsweetened milk	from baseline to month 3, from baseline to month 6
Secondary	BevQ 15 -Parental Change in Volume of Beverage Consumption	changes in total volume for parents including water and unsweetened milk	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 including water and unsweetened milk	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, including how SSB are related to possible health consequences and perceived healthfulness of different beverages.	from baseline to month 3, from baseline to 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 to month 3, from baseline to 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 to month 3, from baseline to 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