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

NCT04886817 | Completed

• 1 other identifier: IRB00062659
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Obesity, Childhood

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• BevQ 15 - Children Change in Servings of Beverages

  from baseline to month 3, from baseline to month 6

• BevQ 15 - Children Change in total Volume of Beverages

  from baseline to month 3, from baseline to month 6

• BevQ 15 - Children Change in total calories of beverages consumption

  from baseline to month 3, from baseline to month 6

• BevQ 15 -Parental Change in Sugary beverage consumption

  from baseline to month 3, from baseline to month 6

• BevQ 15 -Parental Change in Beverage Consumption

  from baseline to month 3, from baseline to month 6

Other Outcomes (3)

• Single Item Literacy Screener (SILS)

  baseline

• Modified Version of the Mobile Device Proficiency Questionnaire (MDPQ)

  baseline

• NCI's 26-item Dietary Screener Questionnaire (DSQ)

  baseline, month 6

Study Arms (2)

Control

NO INTERVENTION

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

EXPERIMENTAL

Intervention group participants will receive a 6-month behavioral intervention with the following components: 1. 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) 2. A 5-minute educational video that introduces parents to healthy drink choices for the family. 3. 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. 4. 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

Interventions

Pilot Intervention to reduce SSB consumption in children and families BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest School of Medicine

Winston-Salem, North Carolina, 27028, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristina H Lewis, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 14, 2021
• Study Start: June 17, 2021
• Primary Completion: November 18, 2021
• Study Completion: November 18, 2021
• Last Updated: March 10, 2022

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)