Childhood ObesityNCT01541761
Starting Early Obesity Prevention Program
A study testing Family groups in people with Childhood Obesity, run by NYU Langone Health at 1 site in United States.
Trial summary
The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Family groups
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to 1 Aug 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Latina mother > 18 years with singleton uncomplicated pregnancy
- Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services
- Mother to be primary caregiver of child
- Mother speaks fluent English or Spanish
Who cannot join
- Maternal history of serious medical or psychiatric illness or drug or alcohol abuse
- Family does not have a phone
- Infants with severe medical problems that may affect feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Bellevue Hospital Center Ambulatory Care Clinic
New York, New York, 10016
About this study
Official title: RCT Testing the Effectiveness of an Early Obesity Prevention Program
The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.
The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.
Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices
Read the detailed description
Expected outcomes include: (1) Reduction in the prevalence and degree of obesity. (2) Improvement in child diet composition. (3) Improvement in parent feeding knowledge, attitudes, styles and practices including. (4) Improvement in lifestyle behaviors, such as sleep, screen time and physical activity, associated with increased risk of obesity. (5) Improvement in parent diet.
Our secondary objective is to understand the mechanisms by which changes in parent knowledge and behavioral factors mediate impacts of the intervention on childhood obesity. We will also study relationships between potential moderators and intervention impacts. The new components of the expanded Starting Early Program will be feasible: Families will participate in the preschool intervention, and pregnant women will enroll in the prenatal intervention.
- Conditions
- Childhood Obesity
- Being tested
- Family groups
- Keywords
- Obesity, Child, Hispanic, Prevention, Nutrition, Parenting
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family groupsBehavioural
The group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting.
| Study group | Role | What they receive |
|---|---|---|
| Family groups | Experimental | Intervention group members will participate in family groups focused on early childhood obesity prevention in addition to standard care from pediatricians at the primary care clinic. Receives: Behavioral: Family groups |
| Standard care | No intervention | Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the prevalence and degree of obesity at age 3 years
Continuous and dichotomized measures (BMI percentiles)
Measured: 3 years
Improvement in infant diet composition
Diets of intervention group infants and children will be more likely to follow recommended guidelines including:
- Increased breastfeeding rates and duration ii) Appropriate timing of introduction to solids iii) Appropriate timing of bottle weaning iv) Increased fruit and vegetable consumption v) Decreased fast and junk food consumption vi) Decreased sugary beverage consumption vii) Age-appropriate portion sizes
Measured: 1-3 years
Improvement in infant lifestyle behaviors associated with increased risk of obesity.
Measures of lifestyle behaviors among infants and children receiving intervention will be more likely to follow recommended guidelines than those of the control group including:
- Better sleep habits ii) Reduced screen time iii) Increased physical activity
Measured: 1-3 years
Improvement in parent feeding knowledge, attitudes, styles and practices
Parent feeding knowledge, attitudes, styles and practices in the intervention group will be healthier than those of the control group including:
- Awareness of healthy child weight ii) Improved knowledge of optimal feeding practices iii) More responsive feeding style
Measured: 1-3 years
Reduction in infant and child excess weight gain
Continuous anthropometric measures (weight for length z-scores)
Measured: 1-3 years
Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention
Will be feasible, intervention mothers will have improved nutrition knowledge, and feeding attitudes, styles and behaviors
Measured: 2-5 years
Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention
Will be feasible, ii) intervention women will have improved nutrition knowledge and behaviors, iii) intervention women will have improved gestational weight gain
Measured: 2-5 years
Feasibility process measures:
Study population eligibility and enrollment, Proportion of pregnant women approached who meet eligibility criteria, Proportion of women meeting eligibility criteria who enroll These proportions will be calculated using study recruitment records.
Measured: 2-5 years
Participant engagement
Proportion of enrolled mother-infant dyads that participate in the different aspects of the program. This will include the number of individual sessions with healthy steps, the number of individual sessions with the health educator, the number and type of referrals to community resources provided, and the number of Nutrition and Parenting Support Groups attended. This will enable us to determine the length of engagement in the program, proportion of enrolled mother-infant dyads that complete each study measure
Measured: 2-5 years
Participant satisfaction
We will assess program satisfaction
Measured: 2-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startApr 2012
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Responsible party
- Sponsor
- Investigators
- Mary Jo Messito, MD, Principal investigator, NYU School of MedicineRachel Gross, MD MS, Principal investigator, Children's Hospital at Montefiore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541761
- Sponsor's protocol ID
- 10-02175
- Status last verified
- Jun 2025
- First submitted
- 24 Feb 2012
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duh-Leong C, Messito MJ, Katzow MW, Kim CN, Mendelsohn AL, Scott MA, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention: Effects of Adverse Social Determinants of Health on Intervention Attendance and Impact. Child Obes. 2024 Oct;20(7):476-484. doi: 10.1089/chi.2023.0149. Epub 2024 Feb 1.
PubMed 38301173Vandyousefi S, Messito MJ, Scott MA, Gross RS. Do Appetite Traits Mediate the Link Between Birth Weight and Later Child Weight in Low-Income Hispanic Families? Child Obes. 2023 Oct;19(7):489-497. doi: 10.1089/chi.2022.0124. Epub 2022 Oct 17.
PubMed 36255444Katzow MW, Messito MJ, Mendelsohn AL, Scott MA, Gross RS. Protective Effect of Prenatal Social Support on the Intergenerational Transmission of Obesity in Low-Income Hispanic Families. Child Obes. 2023 Sep;19(6):382-390. doi: 10.1089/chi.2021.0306. Epub 2022 Sep 15.
PubMed 36112108Messito MJ, Mendelsohn AL, Katzow MW, Scott MA, Vandyousefi S, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program: A Randomized Trial. Pediatrics. 2020 Oct;146(4):e20200709. doi: 10.1542/peds.2020-0709. Epub 2020 Sep 3.
PubMed 32883807Gross RS, Mendelsohn AL, Yin HS, Tomopoulos S, Gross MB, Scheinmann R, Messito MJ. Randomized controlled trial of an early child obesity prevention intervention: Impacts on infant tummy time. Obesity (Silver Spring). 2017 May;25(5):920-927. doi: 10.1002/oby.21779. Epub 2017 Mar 22.
PubMed 28332324Gross RS, Mendelsohn AL, Gross MB, Scheinmann R, Messito MJ. Randomized Controlled Trial of a Primary Care-Based Child Obesity Prevention Intervention on Infant Feeding Practices. J Pediatr. 2016 Jul;174:171-177.e2. doi: 10.1016/j.jpeds.2016.03.060. Epub 2016 Apr 21.
PubMed 27113376
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT Testing the Effectiveness of an Early Obesity Prevention Program
- ClinicalTrials.gov ID
- NCT01541761
- Acronym / sponsor ID
- 10-02175
- Conditions
- Childhood Obesity
- Keywords
- Obesity, Child, Hispanic, Prevention, Nutrition, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA)
- Study start
- Apr 2012 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 1 Mar 2012 (estimated)
- 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.
The proposed study is a randomized controlled trial to test the effectiveness of a primary care, family-centered child obesity prevention program beginning in pregnancy and continuing throughout the first three years of life compared to routine standard of care. The study aims to reduce the prevalence of obesity at age three, improve child diet composition and healthy lifestyle behaviors. Pregnant women will be enrolled from a large urban medical center serving primarily low-income immigrant Latino families. The intervention "Starting Early" will consist of three components. 1) Family Groups: interactive groups coordinated with the child's primary care visits and led by a Nutritionist/ Child Developmental Specialist. 2) Nutritional Video: a culturally-specific bilingual early nutrition video will be incorporated into family group discussions. 3) Plain Language Handouts: given to reinforce the curriculum from the family groups.
The proposed research included in the funding continuation is titled: "Starting Early: Expansion of a Primary Care-Based Early Child Obesity Prevention Program". It adds three major components to the current project: 1) Following the original Starting Early cohort until age 5; 2) Developing and piloting an extended Starting Early preschool intervention for children aged 3-5 years.; 3) Developing and piloting an extended Starting Early prenatal intervention for women in the 1st trimester of pregnancy. A new cohort of 200 women in the first trimester of pregnancy will be recruited for the prenatal intervention; all women will receive the intervention in this feasibility trial.
Hypothesis: Compared to controls, the intervention group will show reduced obesity and improved parent feeding knowledge and increased healthy feeding attitudes, styles and practices
Detailed description
Expected outcomes include: (1) Reduction in the prevalence and degree of obesity. (2) Improvement in child diet composition. (3) Improvement in parent feeding knowledge, attitudes, styles and practices including. (4) Improvement in lifestyle behaviors, such as sleep, screen time and physical activity, associated with increased risk of obesity. (5) Improvement in parent diet.
Our secondary objective is to understand the mechanisms by which changes in parent knowledge and behavioral factors mediate impacts of the intervention on childhood obesity. We will also study relationships between potential moderators and intervention impacts. The new components of the expanded Starting Early Program will be feasible: Families will participate in the preschool intervention, and pregnant women will enroll in the prenatal intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family groups | Experimental | Behavioral: Family groupsIntervention group members will participate in family groups focused on early childhood obesity prevention in addition to standard care from pediatricians at the primary care clinic. |
| Standard care | No intervention | –Mothers enrolled into the control group will continue to receive care from their pediatrician in the primary care clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Latina mother > 18 years with singleton uncomplicated pregnancy
- Receiving prenatal care and the intention to receive pediatric care at Bellevue Hospital Center or Gouverneur Healthcare Services
- Mother to be primary caregiver of child
- Mother speaks fluent English or Spanish
Key exclusion criteria (3 listed)
- Maternal history of serious medical or psychiatric illness or drug or alcohol abuse
- Family does not have a phone
- Infants with severe medical problems that may affect 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 |
|---|---|---|
| Family groupsThe group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting. | Behavioural | Family groups |
Primary outcome
Reduction in the prevalence and degree of obesity at age 3 years
Time frame: 3 years
Continuous and dichotomized measures (BMI percentiles)
Improvement in infant diet composition
Time frame: 1-3 years
Diets of intervention group infants and children will be more likely to follow recommended guidelines including: i) Increased breastfeeding rates and duration ii) Appropriate timing of introduction to solids iii) Appropriate timing of bottle weaning iv) Increased fruit and vegetable consumption v) Decreased fast and junk food consumption vi) Decreased sugary beverage consumption vii) Age-appropriate portion sizes
Improvement in infant lifestyle behaviors associated with increased risk of obesity.
Time frame: 1-3 years
Measures of lifestyle behaviors among infants and children receiving intervention will be more likely to follow recommended guidelines than those of the control group including: i) Better sleep habits ii) Reduced screen time iii) Increased physical activity
Improvement in parent feeding knowledge, attitudes, styles and practices
Time frame: 1-3 years
Parent feeding knowledge, attitudes, styles and practices in the intervention group will be healthier than those of the control group including: i) Awareness of healthy child weight ii) Improved knowledge of optimal feeding practices iii) More responsive feeding style
Reduction in infant and child excess weight gain
Time frame: 1-3 years
Continuous anthropometric measures (weight for length z-scores)
Additional Outcome Measures for the Expanded Starting Early Program: Preschool intervention
Time frame: 2-5 years
Will be feasible, intervention mothers will have improved nutrition knowledge, and feeding attitudes, styles and behaviors
Additional Outcome Measures for the Expanded Starting Early Program: Prenatal Intervention
Time frame: 2-5 years
Will be feasible, ii) intervention women will have improved nutrition knowledge and behaviors, iii) intervention women will have improved gestational weight gain
Feasibility process measures:
Time frame: 2-5 years
Study population eligibility and enrollment, Proportion of pregnant women approached who meet eligibility criteria, Proportion of women meeting eligibility criteria who enroll These proportions will be calculated using study recruitment records.
Participant engagement
Time frame: 2-5 years
Proportion of enrolled mother-infant dyads that participate in the different aspects of the program. This will include the number of individual sessions with healthy steps, the number of individual sessions with the health educator, the number and type of referrals to community resources provided, and the number of Nutrition and Parenting Support Groups attended. This will enable us to determine the length of engagement in the program, proportion of enrolled mother-infant dyads that complete each study measure
Participant satisfaction
Time frame: 2-5 years
We will assess program satisfaction
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 15 Jun 2025.
- Derived from this study: PubMed 38301173Duh-Leong C, Messito MJ, Katzow MW, Kim CN, Mendelsohn AL, Scott MA, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention: Effects of Adverse Social Determinants of Health on Intervention Attendance and Impact. Child Obes. 2024 Oct;20(7):476-484. doi: 10.1089/chi.2023.0149. Epub 2024 Feb 1.
- Derived from this study: PubMed 36255444Vandyousefi S, Messito MJ, Scott MA, Gross RS. Do Appetite Traits Mediate the Link Between Birth Weight and Later Child Weight in Low-Income Hispanic Families? Child Obes. 2023 Oct;19(7):489-497. doi: 10.1089/chi.2022.0124. Epub 2022 Oct 17.
- Derived from this study: PubMed 36112108Katzow MW, Messito MJ, Mendelsohn AL, Scott MA, Gross RS. Protective Effect of Prenatal Social Support on the Intergenerational Transmission of Obesity in Low-Income Hispanic Families. Child Obes. 2023 Sep;19(6):382-390. doi: 10.1089/chi.2021.0306. Epub 2022 Sep 15.
- Derived from this study: PubMed 32883807Messito MJ, Mendelsohn AL, Katzow MW, Scott MA, Vandyousefi S, Gross RS. Prenatal and Pediatric Primary Care-Based Child Obesity Prevention Program: A Randomized Trial. Pediatrics. 2020 Oct;146(4):e20200709. doi: 10.1542/peds.2020-0709. Epub 2020 Sep 3.
- Derived from this study: PubMed 28332324Gross RS, Mendelsohn AL, Yin HS, Tomopoulos S, Gross MB, Scheinmann R, Messito MJ. Randomized controlled trial of an early child obesity prevention intervention: Impacts on infant tummy time. Obesity (Silver Spring). 2017 May;25(5):920-927. doi: 10.1002/oby.21779. Epub 2017 Mar 22.
- Derived from this study: PubMed 27113376Gross RS, Mendelsohn AL, Gross MB, Scheinmann R, Messito MJ. Randomized Controlled Trial of a Primary Care-Based Child Obesity Prevention Intervention on Infant Feeding Practices. J Pediatr. 2016 Jul;174:171-177.e2. doi: 10.1016/j.jpeds.2016.03.060. Epub 2016 Apr 21.
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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.
Mary Jo Messito, MD principal investigator
NYU School of Medicine
Rachel Gross, MD MS principal investigator
Children's Hospital at Montefiore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family groups in people with Childhood Obesity, run by NYU Langone Health 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 3 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 15 Jun 2025. 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?
Reduction in the prevalence and degree of obesity at age 3 years (time frame: 3 years). The study lists 10 primary outcomes in all. 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 NCT01541761, which also lists 6 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 15 Jun 2025.