Clinical trial NCT04886817: Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families
Official title: A Health Systems Intervention to Reduce Sugar-Sweetened Beverage Consumption in Young Children and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Childhood
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-05-14
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in child sugary drink serving consumption
timeFrame: from baseline to month 3
measure: Change in child sugary drink serving consumption
timeFrame: from baseline to month 6
Secondary outcomes:
measure: BevQ 15 - Children Change in Servings of Beverages
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in total Volume of Beverages
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 - Children Change in total calories of beverages consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Sugary beverage consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Beverage Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15 -Parental Change in Volume of Beverage Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: BevQ 15-Parental Change in Calories of Beverage Consumption
timeFrame: from baseline to month 3, from baseline to month 6
measure: Changes in parent knowledge
timeFrame: from baseline to month 3, from baseline to month 6
measure: Changes in Parent Attitudes
timeFrame: from baseline to month 3, from baseline to month 6
measure: Changes in Parent Beliefs
timeFrame: from baseline to month 3, from baseline to month 6
measure: Child Weight Change
timeFrame: from baseline to month 3, from baseline to month 6
measure: Child Body Mass Index Z-Score (BMIz) Change
timeFrame: from baseline to month 3, from baseline to month 6
Other outcomes:
measure: Single Item Literacy Screener (SILS)
timeFrame: baseline
measure: Modified Version of the Mobile Device Proficiency Questionnaire (MDPQ)
timeFrame: baseline
measure: NCI's 26-item Dietary Screener Questionnaire (DSQ)
timeFrame: baseline, month 6
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kristina H Lewis, MD
role: PRINCIPAL_INVESTIGATOR
References: