Obesity, InfantNCT05225649
Health e-Baby: Trial to Reduce Obesity Risk Factors During the First 1,000 Days
A study testing Behavior Change Intervention in people with Obesity, Infant, run by Columbia University at 1 site in United States.
Trial summary
Specific Aim: Feasibility of a Pilot Randomized Controlled Trial (RCT) in Pregnancy and Infancy to Reduce Childhood Obesity Risk Factors in Early Life. The main outcomes are feasibility of the intervention components and data collection. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Infant
- What is being tested?
- Behavior Change Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2022to 1 Sep 2024
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years at time of enrollment
- Gestational age 10-20 weeks at time of enrollment
- Receiving primary care or prenatal care at Columbia/New-York Presbyterian site
- Planned delivery at Columbia/New-York Presbyterian with planned continuation of primary care (postpartum and pediatric) at Columbia/New-York Presbyterian
- Ability to read and respond to questions in English or Spanish
- Smart phone ownership
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- Willingness to receive information by smart phone for 18-month intervention and follow-up duration
- Willingness to be randomized into an observational study or an intervention and complete all study components
- Gives permission to participate in receiving messages to their smart phone and email
- Gives permission to complete all study procedures
- Has a physician's clearance for light to moderate physical activity
- Has an active email address
- Capable of providing informed consent
- Has access to Wi-Fi connection in their household
Who cannot join
- Multiple gestation
- Pre-pregnancy body mass index <18.5 kg/m2 >40
- Major fetal anomaly
- Fetal genetic abnormality
- Planned termination of pregnancy
- Chronic medical conditions that affect nutrition or prohibit regular exercise or alter weight status such as:
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- Diseases associated with glucose metabolism
- Diabetes (Type 1, type 2)
- Inflammatory Bowel Disease (Crohn's disease, ulcerative colitis)
- History of gastric bypass/gastric sleeve
- Uncontrolled thyroid disease (hypo or hyperthyroidism)
- Condition requiring enteral tube feeding
- Congenital or acquired heart disease that impacts nutritional needs and physical activity ability
- HIV/AIDS
- Kidney disease
- Cancer
- Uncontrolled autoimmune disease
- Lupus
- Multiple sclerosis
- Sickle cell disease
- Zika infection
- Taking or planning to take certain prescription medications including high dose glucocorticoids, atypical antipsychotics associated with weight gain (such as risperdal (risperidone), clozapine (clozaril), olanzapine (zyprexa), quetiapine (seroquel), etc.), or other prescription weight loss medications
- Personal history of breast cancer or any other type of cancer other than a basal cell skin cancer
- Personal history of cardiovascular disease (coronary artery disease, congestive heart failure, valvular heart disease, stroke, transient ischemic attack, or intermittent claudication), kidney disease, liver disease, venous or arterial thromboembolic disease, adrenal insufficiency, depression requiring hospitalization within the past 6 months, or non-pregnancy related illness requiring overnight hospitalization in the past 6 months
- Underlying disease/treatment that might interfere with participation in/completion of the study (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician)
- Other active medical problems detected by examination or laboratory testing
- Inability to complete study visits or intervention components
- Unwillingness or inability to commit to a 18-month research study for them or their child, including plans to move away
- Plans to be in a different geographic area within the next 2 years
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Randomized Controlled Trial to Reduce Obesity Risk Factors During the First 1,000 Days
Specific Aim: Feasibility of a Pilot Randomized Controlled Trial (RCT) in Pregnancy and Infancy to Reduce Childhood Obesity Risk Factors in Early Life.
The main outcomes are feasibility of the intervention components and data collection. Study will use maternal body mass index (BMI) and child weight-for-length outcomes to estimate sample size needed for a full-scale trial to test intervention efficacy. Primary analysis for full-scale trial power and sample size calculations will be conducted using child weight-for-length data at Child Age 12 Months Visit. Data collected will inform future interventions.
Read the detailed description
Early life interventions to prevent childhood obesity among disproportionately burdened populations are needed to reduce childhood obesity.
The overall goal of this study is to test the feasibility of a pilot randomized controlled trial to promote healthy maternal weight in pregnancy and post-partum and normal child weight-for-length from birth to age 12 months. The study will include 50 women (enrollment up to 70 to account for potential attrition) in pregnancy and their child through age 12 months to examine rates of study component completion, study component satisfaction, and retention. Women enrolled in the intervention will participate in virtual health coaching and receive self-directed behavior change materials by text and email. The results of this study will help us develop efficacious childhood obesity prevention interventions and determine how many study participants would be needed for a full-scale trial. Ultimately, this research could open new avenues for studying ways to promote health starting early in life.
- Conditions
- Obesity, Infant
- Being tested
- Behavior Change Intervention
- Keywords
- First 1,000 days, Mobile Health, Behavior Change Intervention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior Change InterventionBehavioural
Health coaching sessions; self-monitoring: Fitbit, home scale, and app; personalized health information by mobile health: growth charts and age-specific health behavior information via text message and email; behavior change support by mobile health: family-based health behavior goal setting via chatbot; and usual clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Behavior Change Intervention | Experimental | Participants will receive health coaching, patient-directed behavior change support by mobile health, and usual clinical care. Receives: Behavioral: Behavior Change Intervention |
| Control | No intervention | Participants will receive usual clinical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm specific retention rates at 18 months
The retention rate will be defined as the proportion of enrolled individuals who complete infant age 12-months study visits (study month 18) according to each arm.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start14 Jan 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, InfantStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Responsible party
- Sponsor
- Investigators
- Ali Mencin, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225649
- Sponsor's protocol ID
- AAAT7915
- Status last verified
- Nov 2024
- First submitted
- 17 Jan 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial to Reduce Obesity Risk Factors During the First 1,000 Days
- ClinicalTrials.gov ID
- NCT05225649
- Acronym / sponsor ID
- AAAT7915
- Conditions
- Obesity, Infant
- Keywords
- First 1,000 days, Mobile Health, Behavior Change Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Doris Duke Charitable Foundation
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 4 Feb 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.
Specific Aim: Feasibility of a Pilot Randomized Controlled Trial (RCT) in Pregnancy and Infancy to Reduce Childhood Obesity Risk Factors in Early Life.
The main outcomes are feasibility of the intervention components and data collection. Study will use maternal body mass index (BMI) and child weight-for-length outcomes to estimate sample size needed for a full-scale trial to test intervention efficacy. Primary analysis for full-scale trial power and sample size calculations will be conducted using child weight-for-length data at Child Age 12 Months Visit. Data collected will inform future interventions.
Detailed description
Early life interventions to prevent childhood obesity among disproportionately burdened populations are needed to reduce childhood obesity.
The overall goal of this study is to test the feasibility of a pilot randomized controlled trial to promote healthy maternal weight in pregnancy and post-partum and normal child weight-for-length from birth to age 12 months. The study will include 50 women (enrollment up to 70 to account for potential attrition) in pregnancy and their child through age 12 months to examine rates of study component completion, study component satisfaction, and retention. Women enrolled in the intervention will participate in virtual health coaching and receive self-directed behavior change materials by text and email. The results of this study will help us develop efficacious childhood obesity prevention interventions and determine how many study participants would be needed for a full-scale trial. Ultimately, this research could open new avenues for studying ways to promote health starting early in life.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavior Change Intervention | Experimental | Behavioral: Behavior Change InterventionParticipants will receive health coaching, patient-directed behavior change support by mobile health, and usual clinical care. |
| Control | No intervention | –Participants will receive usual clinical care. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Age 18-50 years at time of enrollment
- Gestational age 10-20 weeks at time of enrollment
- Receiving primary care or prenatal care at Columbia/New-York Presbyterian site
- Planned delivery at Columbia/New-York Presbyterian with planned continuation of primary care (postpartum and pediatric) at Columbia/New-York Presbyterian
- Ability to read and respond to questions in English or Spanish
Key exclusion criteria (30 listed)
- Multiple gestation
- Pre-pregnancy body mass index <18.5 kg/m2 >40
- Major fetal anomaly
- Fetal genetic abnormality
- Planned termination of pregnancy
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 |
|---|---|---|
| Behavior Change InterventionHealth coaching sessions; self-monitoring: Fitbit, home scale, and app; personalized health information by mobile health: growth charts and age-specific health behavior information via text message and email; behavior change support by mobile health: family-based health behavior goal setting via chatbot; and usual clinical care. | Behavioural | Behavior Change Intervention |
Primary outcome
Arm specific retention rates at 18 months
Time frame: Up to 18 months
The retention rate will be defined as the proportion of enrolled individuals who complete infant age 12-months study visits (study month 18) according to each arm.
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 8 Nov 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.
Ali Mencin, MD 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 Behavior Change Intervention in people with Obesity, Infant, 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 14 inclusion and 30 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 8 Nov 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?
Arm specific retention rates at 18 months (time frame: Up to 18 months). 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 8 Nov 2024.