Pregnancy RelatedNCT04238585
BabyQ's: Randomized Controlled Trial of Health Messaging in Pregnancy and Infancy
A study testing Mobile messaging in people with Pregnancy Related and Infant Development, run by Columbia University at 1 site in United States.
Trial summary
This randomized controlled intervention evaluates the effect of a mobile health behavioral intervention to test messages to reduce sugar-sweetened beverage intake during pregnancy and infancy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Infant Development
- What is being tested?
- Mobile messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 291 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2020to 17 Feb 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women age 18 years or older or; legal caretakers of infants under 24 months enrolled in WIC
- Can respond to questions in English or Spanish
- Report use of a mobile device using iOS or Android
- Give permission to enroll in messaging system
Who cannot join
- Pregnant women with chronic medical conditions that may impact their nutrition behaviors
- Families whose eligible child has chronic conditions that interest with growth or feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervening to Promote Healthy Weight From Gestation to Age 2, Particularly Among Disproportionately Burdened Populations
This randomized controlled intervention evaluates the effect of a mobile health behavioral intervention to test messages to reduce sugar-sweetened beverage intake during pregnancy and infancy.
The study team will perform a prospective, longitudinal, interventional, randomized control trial by recruiting 300 WIC families during the first 1,000 days of life (pregnancy through infant age 2 months) at consecutive Women, Infants, and Children (WIC) visits to test two interventions compared to a control group. The study team will implement a mobile-based messaging intervention allocate participants to one of 3 arms for a 1 month period: 1) negative message frames, 2) positive message frames, and 3) attention control.
Read the detailed description
Childhood obesity prevalence soared over the past four decades with a 10-fold increase globally from 1975-2015 and Healthy People 2020 has declared obesity a national health priority. Socioeconomic and racial/ethnic disparities in obesity exist and may be widening. These disparities are apparent by age 2 years with recent national data showing that Hispanic children continue to have highest obesity prevalence (15.6%) and on-Hispanic black children have 2-fold higher obesity prevalence (10.4%) compared to non-Hispanic white (5.2%) counterparts. The first 1,000 days describes the period from pregnancy through child age 2 years, and is increasingly recognized as a critical period for development of childhood obesity and its adverse consequences. Several risk factors are consistently associated with later childhood obesity during the first 1,000 days and are more prevalent among low socioeconomic groups and racial/ethnic minorities. These modifiable risk factors mediate the development of racial/ethnic disparities in later childhood obesity.
Sugar-sweetened beverage (SSB) consumption during the first 1,000 days is a risk factor for childhood overweight/obesity, and has been linked to dental caries, lower child cognition, and the adverse child health consequences. Recent evidence shows that maternal SSB consumption during pregnancy and infant SSB consumption in the first year of life are associated with childhood obesity later in life. Thus, interventions to curb SSB consumption and promote healthy beverage intake in urban, low-income Hispanic/Latino families must start early in life, yet few SSB-specific interventions have ventured to do so.
- Conditions
- Pregnancy Related, Infant Development
- Being tested
- Mobile messaging
- Keywords
- Sugar-sweetened beverages, Early life nutrition, First 1000 Days
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile messagingBehavioural
Mobile health messages
| Study group | Role | What they receive |
|---|---|---|
| Negative message frames | Active comparator | Participants will receive messages framed in a negative manner to avoid sugar-sweetened beverages Receives: Behavioral: Mobile messaging |
| Sugar content information messages | Active comparator | Participants will receive messages framed in a positive manner to promote healthy beverage consumption Receives: Behavioral: Mobile messaging |
| Attention Control-Infant Safety | Placebo comparator | Participants will receive messages with infant safety education materials-attention control group Receives: Behavioral: Mobile messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sugar-sweetened beverage (SSB) intake in kcals among adult participants
Determine change from baseline to follow-up in habitual daily caloric intake of SSBs using parent self report of beverage intake
Measured: 1 month
Secondary outcomes (1)
Change in sugar-sweetened beverage (SSB) intake in infants
Determine change from baseline to follow-up in parent-reported infant SSB intake using logistic regression to examine a categorical outcome (any infant SSB consumption v. none)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start27 Jan 2020
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Families who present for a routine WIC visit will be referred for study staff recruitment if they meet either of the following criteria: 1) pregnant woman or 2) parent of child \<24 months enrolled in WIC.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 291 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Principal investigator, Jennifer Woo Baidal, Columbia University
- Investigators
- Jennifer Woo Baidal, MD, MPH, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238585
- Sponsor's protocol ID
- AAAS0859
- Status last verified
- Nov 2021
- First submitted
- 16 Jan 2020
- Last updated
- 16 Nov 2021
- 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervening to Promote Healthy Weight From Gestation to Age 2, Particularly Among Disproportionately Burdened Populations
- ClinicalTrials.gov ID
- NCT04238585
- Acronym / sponsor ID
- AAAS0859
- Conditions
- Pregnancy Related, Infant Development
- Keywords
- Sugar-sweetened beverages, Early life nutrition, First 1000 Days
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 291 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- 27 Jan 2020 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 23 Jan 2020 (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.
This randomized controlled intervention evaluates the effect of a mobile health behavioral intervention to test messages to reduce sugar-sweetened beverage intake during pregnancy and infancy.
The study team will perform a prospective, longitudinal, interventional, randomized control trial by recruiting 300 WIC families during the first 1,000 days of life (pregnancy through infant age 2 months) at consecutive Women, Infants, and Children (WIC) visits to test two interventions compared to a control group. The study team will implement a mobile-based messaging intervention allocate participants to one of 3 arms for a 1 month period: 1) negative message frames, 2) positive message frames, and 3) attention control.
Detailed description
Childhood obesity prevalence soared over the past four decades with a 10-fold increase globally from 1975-2015 and Healthy People 2020 has declared obesity a national health priority. Socioeconomic and racial/ethnic disparities in obesity exist and may be widening. These disparities are apparent by age 2 years with recent national data showing that Hispanic children continue to have highest obesity prevalence (15.6%) and on-Hispanic black children have 2-fold higher obesity prevalence (10.4%) compared to non-Hispanic white (5.2%) counterparts. The first 1,000 days describes the period from pregnancy through child age 2 years, and is increasingly recognized as a critical period for development of childhood obesity and its adverse consequences. Several risk factors are consistently associated with later childhood obesity during the first 1,000 days and are more prevalent among low socioeconomic groups and racial/ethnic minorities. These modifiable risk factors mediate the development of racial/ethnic disparities in later childhood obesity.
Sugar-sweetened beverage (SSB) consumption during the first 1,000 days is a risk factor for childhood overweight/obesity, and has been linked to dental caries, lower child cognition, and the adverse child health consequences. Recent evidence shows that maternal SSB consumption during pregnancy and infant SSB consumption in the first year of life are associated with childhood obesity later in life. Thus, interventions to curb SSB consumption and promote healthy beverage intake in urban, low-income Hispanic/Latino families must start early in life, yet few SSB-specific interventions have ventured to do so.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Families who present for a routine WIC visit will be referred for study staff recruitment if they meet either of the following criteria: 1) pregnant woman or 2) parent of child <24 months enrolled in WIC.
| Arm | Type | Receives |
|---|---|---|
| Negative message frames | Active comparator | Behavioral: Mobile messagingParticipants will receive messages framed in a negative manner to avoid sugar-sweetened beverages |
| Sugar content information messages | Active comparator | Behavioral: Mobile messagingParticipants will receive messages framed in a positive manner to promote healthy beverage consumption |
| Attention Control-Infant Safety | Placebo comparator | Behavioral: Mobile messagingParticipants will receive messages with infant safety education materials-attention control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women age 18 years or older or; legal caretakers of infants under 24 months enrolled in WIC
- Can respond to questions in English or Spanish
- Report use of a mobile device using iOS or Android
- Give permission to enroll in messaging system
Key exclusion criteria (2 listed)
- Pregnant women with chronic medical conditions that may impact their nutrition behaviors
- Families whose eligible child has chronic conditions that interest with growth or feeding
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 |
|---|---|---|
| Mobile messagingMobile health messages | Behavioural | Attention Control-Infant Safety, Negative message frames, Sugar content information messages |
Primary outcome
Change in sugar-sweetened beverage (SSB) intake in kcals among adult participants
Time frame: 1 month
Determine change from baseline to follow-up in habitual daily caloric intake of SSBs using parent self report of beverage intake
1 secondary outcome
Change in sugar-sweetened beverage (SSB) intake in infants
Time frame: 1 month
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 16 Nov 2021.
- 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.
Jennifer Woo Baidal, MD, MPH principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile messaging in people with Pregnancy Related and Infant Development, run by Columbia University 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 4 inclusion and 2 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 16 Nov 2021. 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. Some participants in this study may receive a placebo. 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 sugar-sweetened beverage (SSB) intake in kcals among adult participants (time frame: 1 month). 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 16 Nov 2021.