Obesity in ChildhoodBATNCT03517891
The Baby Act Trial (BAT): a Multimodal Lifestyle Intervention
A study testing WIC+ in people with Obesity in Childhood, run by University of Puerto Rico at 1 site in Puerto Rico.
Trial summary
Childhood obesity is increasing, particularly among Hispanics. Rapid weight gain during childhood increases the risk of obesity in childhood and in adulthood, also increasing the risk of chronic diseases such as diabetes and hypertension. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Obesity in Childhood
- What is being tested?
- WIC+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 530 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 11 May 2018to 31 Jul 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- We will recruit pregnant women age 18 years and older who are participants of the WIC program that:
- are in the 3rd trimester,
- intend to enroll their infant in the WIC program when he/she is born,
- are experiencing singleton pregnancies;
- agree to participate independently of the assigned group; and 5) can read and have access to the internet.
Who cannot join
- We will exclude pregnant women that:
- report high risk pregnancies (history of hypertension of any type, diabetes of any type, antenatal diagnosis of intrauterine growth failure or major congenital anomalies);
- who plan to leave their WIC clinic within the study time frame; and
- a history of emotional or mental health disorders that would preclude active participation in the study. Also newborns who are premature (before week 37 of gestation), with developmental disabilities, with severe conditions such as hypoxic ischemic encephalopathy, feeding disorders, intractable seizures or any other severe neurologic or muscular disorders and metabolic diseases that require specialized diet, and those requiring prolonged hospitalization at birth (>7 days) will also be excluded from participation once the diagnosis is achieved.
Trial locations and contacts
1 site in 1 country.
Puerto Rico1 site
University of Puerto Rico Medical Sciences Campus
San Juan, 00936-5067
About this study
Official title: Intervention to Promote Physical Activation and Improve Sleep and Feeding Practices in Infants for Preventing Obesity Early in Life (The Baby-Act Trial)
Childhood obesity is increasing, particularly among Hispanics. Rapid weight gain during childhood increases the risk of obesity in childhood and in adulthood, also increasing the risk of chronic diseases such as diabetes and hypertension. This can be prevented with interventions during early in life that address multiple risk factors associated with the early development of obesity. Therefore, the purpose of this study is to test an intervention to promote baby activation and improve their sleep patterns and feeding patterns from birth to 12 months of age. For this purpose, pregnant women participating in the Special Nutrition Women, Infants and Children (WIC) Program in Puerto Rico will be recruited and randomly assigned to the control group (usual care within the program) or to the WIC + group (usual care + intervention). The intervention will focus on age-appropriate physical activity for children, healthy sleep and limited time on the screen, healthy dietary patterns and growth monitoring. The content will be delivered with a multimedia approach (web platform, mobile messages and telephone follow-up). If successful, this intervention could be adopted by the WIC program in Puerto Rico to help prevent childhood obesity among its participants. This will help improve the health of minorities and eliminate health disparities among Hispanics and other at-risk groups.
Read the detailed description
Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during critical periods of infancy increases the risk of obesity in childhood, continuing into adulthood. This could be prevented through multifaceted programs that address multiple risk factors (e.g., physical activity, sleep, eating behaviors and parental skills). Evidence on successful lifestyle interventions for childhood obesity prevention often promote a comprehensive approach delivered at multiple levels (i.e., individual, family, and community) and delivered through population-level programs. One such program is The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC serves low-income women who are pregnant and/or have infants and/or young children, groups that are among those at the greatest risk of early weight gain. Our long-term goal is to prevent infant obesity through a structured curriculum that provides a combination of key messages and activities designed to promote sound parenting skills that support and sustain healthy lifestyle (i.e., developmentally appropriate exercises for 'infant activation', sleep and healthy eating behavior) beginning at birth. The proposed intervention is an integrated novel approach leveraging current WIC outreach practices and technology for complementing the current standard of care of the WIC Program. The investigators will assess the clinical effectiveness of this novel complementary intervention among caregivers of infants (0 and 12 months) who are participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 20 WIC clinics located within the San Juan Metropolitan Area of Puerto Rico. In this design, an equal number of clinics will be randomized to the control or intervention arm. The lifestyle intervention will focus on age-appropriate infant's physical activation, healthy sleep and sedentary patterns, and healthy diet quality, by improving parenting skills. Intervention content will be delivered through a combination of technology (multi-media computer-based platforms and mobile messages) and individual counseling (phone and in-person follow-up). Participation in the intervention will begin during the last trimester of pregnancy and will continue until the infant is 12 months of age. The investigators have already tested the information of such an intervention among a small group of 10 mother-infant dyads during their first year of life, with excellent acceptability. Our main outcome is infant rate of weight gain at 12 months of age. Secondary outcomes include: 1) lifestyle behaviors, such as objectively measured hours of infant movement, sedentary behaviors and sleep; 2) diet quality score (which includes breastfeeding and amount of intake of each food group); 3) other feeding practices (i.e. spoon-feeding, addition of foods to the bottle). The research plan also includes a detailed evaluation of the cost of the intervention as a modification of the current WIC curriculum.
- Conditions
- Obesity in Childhood
- Being tested
- WIC+
- Keywords
- Physical activity, Sleep pattern, Nutrition, Education
- Medical subject headings
- Pediatric Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WIC+Behavioural
intervention was based on the Health Self-Empowerment Theory. It will be adapted for the web-based platform using the Persuasive Technology and Persuasive System Design models. These models focus on the human-computer interface and how technology can/is used as a persuasive tool for behavior change. We will also include Bandura's Social Cognitive Theory.
The intervention will be delivered through the combination of:
educational modules provided through an interactive distance learning platform designed to provide learning experiences using multiple modalities; short messaging platforms to promote adoption of healthy behaviors and use of the educational platform; one to one sessions with the interventionist over the telephone.
| Study group | Role | What they receive |
|---|---|---|
| WIC + | Experimental | The intervention consist in the implementation of an enhanced nutritional education and services model through the use of a combination of modalities to disseminate messages and educational materials framed in the health empowerment model. Each component of the intervention has been developed to provide the information consistent with the theoretical framework of the modality being used.
The intervention targets the following behaviors: Infant activation, Healthy sleep patterns, Screen time, Healthy feeding practices. Receives: Behavioral: WIC+ |
| WIC Standard of care (Control) | No intervention | Participants recruited in randomly assigned control clinics will receive the WIC program standard of care. This includes the projected implementation of a web page for the nutritional education contacts. We will update our definition of the PR WIC program standard of care upon recruitment initiation and throughout the study implementation phase. We will also document the utilization rate of the web base platform provided by WIC among the control participants to determine baseline use of distance learning platforms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate weight gain during first year
The main study outcome is adequate weight gain based on gender adjusted Z score using the World Health Organization weight (kilogram) for length (centimeter) growth curves.
Measured: one year
Secondary outcomes (12)
Objective assessment of infant activity.
Infant movement and activity patterns will be evaluated using accelerometry data.
Measured: 0-1 month, 6 months, 1 year
Objective sleep measures
Accelerometry data will be analyzed to assess sleep patterns in infants.
Measured: 0-1 month, 6 months, 1 year
General Infant Feeding Practices Questionnaire
This will be assessed from the General Feeding Practices Questionnaire completed at each assessment visit. This instrument was developed to document breastfeeding practices, time of introduction of foods and the presence of other stimuli while feeding.
Measured: 0-1 month, 6 months, 1 year
Diet quality
This will be measured using a validated infant Food Frequency Questionnaire, which will be completed at each assessment visit. The infant food frequency questionnaire was developed to document the food provided to infants 0 to 24 months of age. Information collected allows for calorie and nutrient content assessment and comparison to established nutritional guidelines.
Measured: 0-1 month, 6 months, 1 year
Rate of infant growth.
Difference in gender and age adjusted weight for length Z scores determined using the World Health Organization growth curves at each assessment time-point will be evaluated to determine the impact of the intervention.
Measured: Birth, 1 month, 6 months, 1 year
Reported measures of physical activity
Participants will be asked to complete a survey to document the activities and the time spent performing the activities taught as part of the intervention.
Measured: 0-1 month, 6 months, 1 year
Reported measures of sleep
Participants will be asked to complete a survey to document characteristics of their infant's sleep pattern and duration of sleep periods.
Measured: 0-1, 6 months, 1 year
Weight
The infant's weight will be documented in kilograms at every study assessment time-point and evaluated using the World Health Organization gender appropriate growth curves.
Measured: 0-1 months, 6 months, 1 year
Length
The infant's Length will be documented in centimeters at every study assessment time-point and evaluated using the World Health Organization gender appropriate growth curves.
Measured: 0-1 months, 6 months, 1 year
Head Circumference
As part of the growth assessment the infant's head circumference will be documented in centimeters at every study assessment time-points.
Measured: 0-1 months, 6 months, 1 year
Social determinants of health.
We have added constructs of social capital to our exit interview and integrated the Accountable Health Communities Health-Related Social Needs 10-item screening tool.
Measured: 1 year
Infant Oral Health
We are collecting self reported data related to oral health care and dentition among infants.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study start11 May 2018
- Primary completion30 Jun 2023
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obesity in ChildhoodStudies of the same condition, open and under way.
- 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
- Model description
- Cluster-randomized controlled trial in 16 WIC clinics. We will randomly assign 8 clinics to the intervention arm and 8 to control (usual care) arm. The intervention will combine key messages and activities designed to promote sound parenting skills that support and sustain healthy lifestyles beginning at birth until the infant is 12 months of age. Participants will be recruited at the WIC clinics during in the last trimester of pregnancy. The primary, intention-to-treat, analysis will evaluate the effect of the intervention on excessive weight gain and rate of weight gain from birth until 12 months. The intention-to-treat approach will allow us to evaluate the expected effect of adding the proposed intervention to the current WIC curriculum. Secondary analyses will include effects of the intervention on objective measures of infant activation, sedentary behaviors and sleep, diet quality, and feeding practices.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Puerto Rico
- Sponsor type
- University, hospital or other
- Collaborators
- Marshfield Clinic Research Foundation, Florida International University
- Responsible party
- Sponsor
- Investigators
- Maribel Campos, MD MSc MBA, Principal investigator, University of Puerto Rico Medical Sciences CampusCristina Palacios, PhD MS, Principal investigator, Florida International UniversityJeremy Pomeroy, PhD, Principal investigator, Marshfield Clinic Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517891
- Sponsor's protocol ID
- A4540117
- Acronym
- BAT
- Status last verified
- May 2023
- First submitted
- 20 Apr 2018
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The proposed research will gather data on the effects of a lifestyle intervention to prevent infant obesity: self-reported socio-demographics, lifestyles, health-related variables, compliance to the intervention, anthropometrics. Results have been presented to the Center for Collaborative Health Disparities Research (CCRHD) and National Institute of Minority Health and Health Disparities (NIMHD) Officials regularly. Findings will be reported at Program Project Meetings and other scientific meetings and published in peer-reviewed journals. Data will not be disseminated outside the University of Puerto Rico until the established study outcome measures have been published. Summary data statistics, publication analysis and any other supplementary data will be posted on the Center for Collaborative Health Disparities Research.
Publications
Campos M, Pomeroy J, Mays MH, Lopez A, Palacios C. Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design. Contemp Clin Trials. 2020 Dec;99:106185. doi: 10.1016/j.cct.2020.106185. Epub 2020 Oct 22.
PubMed 33099015Kallis Colon MG, Lopez A, Campos Rivera M, Pomeroy J, Palacios C. Baby-Act Intervention to Prevent Excessive Infant Weight Gain: Development, Implementation, Lessons Learned, and Future Applications. Matern Child Health J. 2025 Apr;29(4):572-581. doi: 10.1007/s10995-025-04082-x. Epub 2025 Mar 22.
PubMed 40120064
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Promote Physical Activation and Improve Sleep and Feeding Practices in Infants for Preventing Obesity Early in Life (The Baby-Act Trial)
- ClinicalTrials.gov ID
- NCT03517891
- Acronym / sponsor ID
- BAT / A4540117
- Conditions
- Obesity in Childhood
- Keywords
- Physical activity, Sleep pattern, Nutrition, Education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 530 participants (actual)
- Lead sponsor
- University of Puerto RicoUniversity, hospital or other
- Collaborators
- Marshfield Clinic Research Foundation, Florida International University
- Study start
- 11 May 2018 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 8 May 2018 (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.
Childhood obesity is increasing, particularly among Hispanics. Rapid weight gain during childhood increases the risk of obesity in childhood and in adulthood, also increasing the risk of chronic diseases such as diabetes and hypertension. This can be prevented with interventions during early in life that address multiple risk factors associated with the early development of obesity. Therefore, the purpose of this study is to test an intervention to promote baby activation and improve their sleep patterns and feeding patterns from birth to 12 months of age. For this purpose, pregnant women participating in the Special Nutrition Women, Infants and Children (WIC) Program in Puerto Rico will be recruited and randomly assigned to the control group (usual care within the program) or to the WIC + group (usual care + intervention). The intervention will focus on age-appropriate physical activity for children, healthy sleep and limited time on the screen, healthy dietary patterns and growth monitoring. The content will be delivered with a multimedia approach (web platform, mobile messages and telephone follow-up). If successful, this intervention could be adopted by the WIC program in Puerto Rico to help prevent childhood obesity among its participants. This will help improve the health of minorities and eliminate health disparities among Hispanics and other at-risk groups.
Detailed description
Infant obesity is increasing in the US, particularly among Hispanics. Rapid weight gain during critical periods of infancy increases the risk of obesity in childhood, continuing into adulthood. This could be prevented through multifaceted programs that address multiple risk factors (e.g., physical activity, sleep, eating behaviors and parental skills). Evidence on successful lifestyle interventions for childhood obesity prevention often promote a comprehensive approach delivered at multiple levels (i.e., individual, family, and community) and delivered through population-level programs. One such program is The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC). WIC serves low-income women who are pregnant and/or have infants and/or young children, groups that are among those at the greatest risk of early weight gain. Our long-term goal is to prevent infant obesity through a structured curriculum that provides a combination of key messages and activities designed to promote sound parenting skills that support and sustain healthy lifestyle (i.e., developmentally appropriate exercises for 'infant activation', sleep and healthy eating behavior) beginning at birth. The proposed intervention is an integrated novel approach leveraging current WIC outreach practices and technology for complementing the current standard of care of the WIC Program. The investigators will assess the clinical effectiveness of this novel complementary intervention among caregivers of infants (0 and 12 months) who are participants of the Puerto Rico WIC program through a cluster-randomized controlled trial in 20 WIC clinics located within the San Juan Metropolitan Area of Puerto Rico. In this design, an equal number of clinics will be randomized to the control or intervention arm. The lifestyle intervention will focus on age-appropriate infant's physical activation, healthy sleep and sedentary patterns, and healthy diet quality, by improving parenting skills. Intervention content will be delivered through a combination of technology (multi-media computer-based platforms and mobile messages) and individual counseling (phone and in-person follow-up). Participation in the intervention will begin during the last trimester of pregnancy and will continue until the infant is 12 months of age. The investigators have already tested the information of such an intervention among a small group of 10 mother-infant dyads during their first year of life, with excellent acceptability. Our main outcome is infant rate of weight gain at 12 months of age. Secondary outcomes include: 1) lifestyle behaviors, such as objectively measured hours of infant movement, sedentary behaviors and sleep; 2) diet quality score (which includes breastfeeding and amount of intake of each food group); 3) other feeding practices (i.e. spoon-feeding, addition of foods to the bottle). The research plan also includes a detailed evaluation of the cost of the intervention as a modification of the current WIC curriculum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster-randomized controlled trial in 16 WIC clinics. We will randomly assign 8 clinics to the intervention arm and 8 to control (usual care) arm. The intervention will combine key messages and activities designed to promote sound parenting skills that support and sustain healthy lifestyles beginning at birth until the infant is 12 months of age. Participants will be recruited at the WIC clinics during in the last trimester of pregnancy. The primary, intention-to-treat, analysis will evaluate the effect of the intervention on excessive weight gain and rate of weight gain from birth until 12 months. The intention-to-treat approach will allow us to evaluate the expected effect of adding the proposed intervention to the current WIC curriculum. Secondary analyses will include effects of the intervention on objective measures of infant activation, sedentary behaviors and sleep, diet quality, and feeding practices.
| Arm | Type | Receives |
|---|---|---|
| WIC + | Experimental | Behavioral: WIC+The intervention consist in the implementation of an enhanced nutritional education and services model through the use of a combination of modalities to disseminate messages and educational materials framed in the health empowerment model. Each component of the intervention has been developed to provide the information consistent with the theoretical framework of the modality being used. The intervention targets the following behaviors: Infant activation, Healthy sleep patterns, Screen time, Healthy feeding practices. |
| WIC Standard of care (Control) | No intervention | –Participants recruited in randomly assigned control clinics will receive the WIC program standard of care. This includes the projected implementation of a web page for the nutritional education contacts. We will update our definition of the PR WIC program standard of care upon recruitment initiation and throughout the study implementation phase. We will also document the utilization rate of the web base platform provided by WIC among the control participants to determine baseline use of distance learning platforms. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- We will recruit pregnant women age 18 years and older who are participants of the WIC program that:
Key exclusion criteria (4 listed)
- We will exclude pregnant women that:
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 |
|---|---|---|
| WIC+intervention was based on the Health Self-Empowerment Theory. It will be adapted for the web-based platform using the Persuasive Technology and Persuasive System Design models. These models focus on the human-computer interface and how technology can/is used as a persuasive tool for behavior change. We will also include Bandura's Social Cognitive Theory. The intervention will be delivered through the combination of: educational modules provided through an interactive distance learning platform designed to provide learning experiences using multiple modalities; short messaging platforms to promote adoption of healthy behaviors and use of the educational platform; one to one sessions with the interventionist over the telephone. | Behavioural | WIC + |
Primary outcome
Adequate weight gain during first year
Time frame: one year
The main study outcome is adequate weight gain based on gender adjusted Z score using the World Health Organization weight (kilogram) for length (centimeter) growth curves.
12 secondary outcomes
Objective assessment of infant activity.
Time frame: 0-1 month, 6 months, 1 year
Objective sleep measures
Time frame: 0-1 month, 6 months, 1 year
General Infant Feeding Practices Questionnaire
Time frame: 0-1 month, 6 months, 1 year
Diet quality
Time frame: 0-1 month, 6 months, 1 year
Rate of infant growth.
Time frame: Birth, 1 month, 6 months, 1 year
Reported measures of physical activity
Time frame: 0-1 month, 6 months, 1 year
Reported measures of sleep
Time frame: 0-1, 6 months, 1 year
Weight
Time frame: 0-1 months, 6 months, 1 year
Length
Time frame: 0-1 months, 6 months, 1 year
Head Circumference
Time frame: 0-1 months, 6 months, 1 year
Social determinants of health.
Time frame: 1 year
Infant Oral Health
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Background: PubMed 33099015Campos M, Pomeroy J, Mays MH, Lopez A, Palacios C. Intervention to promote physical activation and improve sleep and response feeding in infants for preventing obesity early in life, the baby-act trial: Rationale and design. Contemp Clin Trials. 2020 Dec;99:106185. doi: 10.1016/j.cct.2020.106185. Epub 2020 Oct 22.
- Derived from this study: PubMed 40120064Kallis Colon MG, Lopez A, Campos Rivera M, Pomeroy J, Palacios C. Baby-Act Intervention to Prevent Excessive Infant Weight Gain: Development, Implementation, Lessons Learned, and Future Applications. Matern Child Health J. 2025 Apr;29(4):572-581. doi: 10.1007/s10995-025-04082-x. Epub 2025 Mar 22.
- Individual participant dataSharing planned: Yes. The proposed research will gather data on the effects of a lifestyle intervention to prevent infant obesity: self-reported socio-demographics, lifestyles, health-related variables, compliance to the intervention, anthropometrics. Results have been presented to the Center for Collaborative Health Disparities Research (CCRHD) and National Institute of Minority Health and Health Disparities (NIMHD) Officials regularly. Findings will be reported at Program Project Meetings and other scientific meetings and published in peer-reviewed journals. Data will not be disseminated outside the University of Puerto Rico until the established study outcome measures have been published. Summary data statistics, publication analysis and any other supplementary data will be posted on the Center for Collaborative Health Disparities Research.
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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.
Maribel Campos, MD MSc MBA principal investigator
University of Puerto Rico Medical Sciences Campus
Cristina Palacios, PhD MS principal investigator
Florida International University
Jeremy Pomeroy, PhD principal investigator
Marshfield Clinic Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WIC+ in people with Obesity in Childhood, run by University of Puerto Rico at 1 site in Puerto Rico.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Nov 2023. 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 Puerto Rico. 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?
Results are not available in the source record.
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?
Adequate weight gain during first year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03517891, which also lists 2 linked publications.
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 22 Nov 2023.