Obesity, ChildhoodSCOPE-ITNCT04886817
Intervention to Reduce Sugar-Sweetened Beverage (SSB) Consumption in Children and Families
A study testing Pilot Intervention to reduce SSB consumption in children and families in people with Obesity, Childhood, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children. Read more about this study
- Who is it for?
- Ages 1 year and olderHealthy 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2021to 18 Nov 2021
- 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 1 year and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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, 27028
About this study
Official title: A Health Systems Intervention to Reduce Sugar-Sweetened Beverage Consumption in Young Children and Families
Pilot randomized trial of a technology-based intervention to reduce sugary drink consumption and promote water intake in families with young children.
Read the 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.
- Conditions
- Obesity, Childhood
- Being tested
- Pilot Intervention to reduce SSB consumption in children and families
- 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 familiesBehavioural
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
| 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 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. Receives: Behavioral: Pilot Intervention to reduce SSB consumption in children and families |
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 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 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument
Measured: from baseline to month 6
Secondary outcomes (12)
BevQ 15 - Children Change in Servings of Beverages
changes in total servings children including water and unsweetened milk
Measured: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of Beverages
changes in total volume of beverages consumed by children including water and unsweetened milk
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 including water and unsweetened milk
Measured: 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
Measured: 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
Measured: 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
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 including water and unsweetened milk
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, including how SSB are related to possible health consequences and perceived healthfulness of different beverages.
Measured: 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.
Measured: 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.
Measured: from baseline to month 3, from baseline to 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 posted14 May 2021
- Study start17 Jun 2021
- Primary completion18 Nov 2021
- Study completion18 Nov 2021
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina H Lewis, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04886817
- Sponsor's protocol ID
- IRB00062659
- Acronym
- SCOPE-IT
- Status last verified
- May 2021
- First submitted
- 11 May 2021
- Last updated
- 10 Mar 2022
- 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 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Health Systems Intervention to Reduce Sugar-Sweetened Beverage Consumption in Young Children and Families
- ClinicalTrials.gov ID
- NCT04886817
- Acronym / sponsor ID
- SCOPE-IT / IRB00062659
- Conditions
- Obesity, Childhood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 17 Jun 2021 (actual)
- Primary completion
- 18 Nov 2021 (actual)
- Study completion
- 18 Nov 2021 (actual)
- First posted
- 14 May 2021 (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 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.
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 familiesIntervention 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. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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"
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 familiesA 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 | 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 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 6 months after starting intervention, measured with Beverage Intake Questionnaire (BevQ15) instrument
12 secondary outcomes
BevQ 15 - Children Change in Servings of Beverages
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 - Children Change in total Volume of Beverages
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 Sugary beverage consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Beverage Consumption
Time frame: from baseline to month 3, from baseline to month 6
BevQ 15 -Parental Change in Volume of Beverage 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 to month 3, from baseline to month 6
Changes in Parent Attitudes
Time frame: from baseline to month 3, from baseline to month 6
Changes in Parent Beliefs
Time frame: from baseline to month 3, from baseline to 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 10 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Obesity, Childhood
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Recruiting
National Childhood Obesity Prevention Programme BE FIT 24
Childhood Obesity
RecruitingPhase 2
Oxytocin for Weight Loss in Adolescents
Obesity, Adolescent, Oxytocin
Not yet recruitingObservational study
Brain and Obesity Longitudinal Development: Neurobiological Mechanisms of Semaglutide Treatment of Adolescent Obesity
Pediatric Obesity, Obesity
RecruitingObservational study
Early Tracking of Childhood Health Determinants (ETCHED) Study
Diabetes Mellitus, Obesity
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 H 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 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 7 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 10 Mar 2022. 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 10 Mar 2022.