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

NCT ID: NCT04886817

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-17

Study Completion Date

2021-11-18

Brief Summary

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

Detailed Description

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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.

Conditions

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Obesity, Childhood

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention

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.

Group Type EXPERIMENTAL

Pilot Intervention to reduce SSB consumption in children and families

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristina H Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00062659

Identifier Type: -

Identifier Source: org_study_id

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