Obesity, ChildhoodWHISPERNCT05356338
Expanding Health System Intervention Through The Women, Infants and Children (WIC) Program Partnership
A study testing Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC in people with Obesity, Childhood, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families. Read more about this study
- Who is it for?
- Ages 6 months to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood
- What is being tested?
- Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2022to 19 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child 6 months - 4 years old who receives health care attention at Wake Forest pediatric or family medicine practices
- Child enrolled in WIC
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest School of Medicine
Winston-Salem, North Carolina, 27157
About this study
Official title: Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program
Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.
Read the detailed description
This is a pilot 2-arm randomized trial among 30 WIC enrolled families of children 6 months through 4 years old 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 two educational videos, a water promotion toolkit, mobile phone app, series of educational phone calls and extra counseling from WIC nutritionists, 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
- Obesity, Childhood
- Being tested
- Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilot Intervention to reduce SSB consumption in children and families enrolled in WICBehavioural
A 6-month intervention based on the use of 5 components: 2 educational videos, provision of a water-promotion "toolkit," a mobile phone application (app), a series of 14 computerized interactive voice response (IVR) phone calls to parents and 2 counseling sessions by a WIC nutritionist to compare families' SSB's consumption behaviors
| Study group | Role | What they receive |
|---|---|---|
| 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 participants will receive a 6-month behavioral intervention with the following components: A water promotion toolkit that includes water bottles, water flavor infusers, stickers to decorate bottles, children's book about water consumption, and instructions for other intervention components (how to view videos, download app, and prepare for calls) Two brief educational videos: a 5-minute video about healthy drink choices for the family and a 3-min video educating residents about local water. Ready, Set Gulp! app 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. 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.
Two counseling sessions by a WIC nutritionist at months 2 and 4 Receives: Behavioral: Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument
Measured: 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 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument
Measured: from baseline to month 6
Secondary outcomes (19)
BevQ 15 - Children Change in Servings of Water Consumption
changes in total servings of water consumed by children
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in Servings of SSBs Consumption
changes in total servings of SSBs consumed by children
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption
changes in total servings of 100% fruit juice consumed by children
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of Water Consumption
changes in total volume of water consumed by children
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of SSBs Consumption
changes in total volume of SSBs consumed by children
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption
changes in total volume of 100% fruit juice consumed by children
Measured: 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
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Servings of Water Consumption
Changes in total servings of water consumed by parents
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Servings of SSBs Consumption
Changes in total servings of SSBs consumed by parents
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption
Changes in total servings of 100% fruit juice consumed by parents
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Volume of Water Consumption
changes in total volume of water consumed by parents
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Volume of SSBs Consumption
changes in total volume of SSBs consumed by parents
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption
changes in total volume of 100% fruit juice consumed by parents
Measured: 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
Measured: 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.
Measured: from baseline, 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.
Measured: from baseline, 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.
Measured: from baseline, month 6
Child Weight Change
change in child weight (kg) using Electronic Health Record (EHR) data
Measured: 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
Measured: from baseline to month 3, from baseline to month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start25 May 2022
- Primary completion19 Sep 2023
- Study completion19 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Lewis, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356338
- Sponsor's protocol ID
- IRB00073800
- Acronym
- WHISPER
- Status last verified
- Apr 2023
- First submitted
- 27 Apr 2022
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding Reach of a Health System Intervention for Family Beverage Choice by Partnering With a Local WIC Program
- ClinicalTrials.gov ID
- NCT05356338
- Acronym / sponsor ID
- WHISPER / IRB00073800
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 19 Sep 2023 (actual)
- Study completion
- 19 Sep 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot test the health system-based intervention to improve family beverage choices and promote water consumption, engaging WIC nutritionists to augment the intervention with follow-up and counseling of families at regularly-scheduled WIC appointments in a small randomized trial among 30 WIC-enrolled families.
Detailed description
This is a pilot 2-arm randomized trial among 30 WIC enrolled families of children 6 months through 4 years old 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 two educational videos, a water promotion toolkit, mobile phone app, series of educational phone calls and extra counseling from WIC nutritionists, 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Pilot Intervention to reduce SSB consumption in children and families enrolled in WICIntervention participants will receive a 6-month behavioral intervention with the following components: A water promotion toolkit that includes water bottles, water flavor infusers, stickers to decorate bottles, children's book about water consumption, and instructions for other intervention components (how to view videos, download app, and prepare for calls) Two brief educational videos: a 5-minute video about healthy drink choices for the family and a 3-min video educating residents about local water. Ready, Set Gulp! app 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. 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. Two counseling sessions by a WIC nutritionist at months 2 and 4 |
Who may qualify
- Ages
- 6 months to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Child 6 months - 4 years old who receives health care attention at Wake Forest pediatric or family medicine practices
- Child enrolled in WIC
- 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
Key exclusion criteria (8 listed)
- 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"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pilot Intervention to reduce SSB consumption in children and families enrolled in WICA 6-month intervention based on the use of 5 components: 2 educational videos, provision of a water-promotion "toolkit," a mobile phone application (app), a series of 14 computerized interactive voice response (IVR) phone calls to parents and 2 counseling sessions by a WIC nutritionist to compare families' SSB's consumption behaviors | Behavioural | Intervention |
Primary outcome
Change in child sugary drink serving consumption
Time frame: 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 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument
Change in child sugary drink serving consumption
Time frame: from baseline to month 6
change in a child's combined consumption of Sugar-Sweetened Beverages (SSB)+Fruit Juice (FJ), measured as total servings per day, at 3 and 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument
19 secondary outcomes
BevQ 15 - Children Change in Servings of Water Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in Servings of SSBs Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in Servings of 100% Fruit Juice Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of Water Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of SSBs Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of 100% Fruit Juice Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total calories of beverages consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Servings of Water Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Servings of SSBs Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Servings of 100% Fruit Juice Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Volume of Water Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Volume of SSBs Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Volume of 100% fruit juice Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15-Parental Change in Calories of Beverage Consumption
Time frame: from baseline to month 3, from baseline to month 6
Changes in parent knowledge
Time frame: from baseline, month 6
Changes in Parent Attitudes
Time frame: from baseline, month 6
Changes in Parent Beliefs
Time frame: from baseline, month 6
Child Weight Change
Time frame: from baseline to month 3, from baseline to month 6
Child Body Mass Index Z-Score (BMIz) Change
Time frame: from baseline to month 3, from baseline to month 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Lewis, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilot Intervention to reduce SSB consumption in children and families enrolled in WIC in people with Obesity, Childhood, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in child sugary drink serving consumption (time frame: from baseline to month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.