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

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

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

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: Pilot Intervention to reduce SSB consumption in children and families

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27028
      • Wake Forest School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; 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.
Experimental: Intervention; Intervention group 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, and a children's book about water consumption, as well as instructions for other intervention components (how to view video, download app, and prepare for calls); A 5-minute educational video that introduces parents to healthy drink choices for the family.; Ready, Set Gulp! A smartphone application 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
Child Weight Change	change in child weight (kg) using Electronic Health Record (EHR) data	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	from baseline to month 3, from baseline to month 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Kristina H Lewis, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2021
• Primary Completion (Actual): November 18, 2021
• Study Completion (Actual): November 18, 2021

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 10, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity
• Other Study ID Numbers: IRB00062659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No