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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristina H Lewis, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27028 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | May 20, 2021 | Feb 22, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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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.
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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 |
| 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 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |