Obesity, Childhood
Conditions
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.
Interventions
BEHAVIORALPilot 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
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in child sugary drink serving consumption | from baseline to month 3 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| BevQ 15 -Parental Change in Volume of Beverage Consumption | from baseline to month 3, from baseline to month 6 | changes in total volume for parents including water and unsweetened milk |
| Changes in Parent Beliefs | from baseline to month 3, from baseline to month 6 | 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. |
| Child Weight Change | from baseline to month 3, from baseline to month 6 | change in child weight (kg) using Electronic Health Record (EHR) data |
| Child Body Mass Index Z-Score (BMIz) Change | from baseline to month 3, from baseline to month 6 | change in child BMIz also using EHR data |
| BevQ 15 - Children Change in Servings of Beverages | from baseline to month 3, from baseline to month 6 | changes in total servings children including water and unsweetened milk |
| BevQ 15 - Children Change in total Volume of Beverages | from baseline to month 3, from baseline to month 6 | changes in total volume of beverages consumed by children including water and unsweetened milk |
| BevQ 15 - Children Change in total calories of beverages consumption | from baseline to month 3, from baseline to month 6 | Changes in calories of beverages consumed by children including water and unsweetened milk |
| BevQ 15 -Parental Change in Sugary beverage consumption | from baseline to month 3, from baseline to month 6 | changes in parental beverage consumption sugary drink serving |
| BevQ 15 -Parental Change in Beverage Consumption | from baseline to month 3, from baseline to month 6 | changes in total servings for parents including water and unsweetened milk |
| BevQ 15-Parental Change in Calories of Beverage Consumption | from baseline to month 3, from baseline to month 6 | changes in total beverage calories for parents including water and unsweetened milk |
| Changes in parent knowledge | from baseline to month 3, from baseline to month 6 | 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. |
| Changes in Parent Attitudes | from baseline to month 3, from baseline to month 6 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| NCI's 26-item Dietary Screener Questionnaire (DSQ) | baseline, month 6 | 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. |
| Modified Version of the Mobile Device Proficiency Questionnaire (MDPQ) | baseline | 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. |
| Single Item Literacy Screener (SILS) | baseline | 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 |
Countries
United States
Outcome results
None listed