Child ObesityNCT06486922
Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
A study testing StEP OUT in people with Child Obesity and Breast Feeding, run by Northwell Health at 1 site in United States.
Trial summary
The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Child Obesity, Breast Feeding, Feeding Behavior
- What is being tested?
- StEP OUT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2024to 30 Apr 2026
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant with at least 14 weeks estimated gestational age
- Self-identify as Hispanic/Latinx
- Speak fluent English or Spanish
- At least 18 years of age
- Has a phone or device to participate in video calls
- Receiving or eligible to receive WIC benefits
Who cannot join
- Diminished mental capacity
- Serious medical or psychiatric illness
- Serious fetal illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Long Island Jewish Medical Center
New Hyde Park, New York, 11040
About this study
The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods.
Read the detailed description
This intervention development study will enroll three to four consecutive cohorts to receive Starting Early to Prevent Obesity Using Telehealth (StEP OUT), an online, group-based nutrition education and parenting support program beginning in the third trimester of pregnancy and continuing through the first four to six months of infancy. It is tailored to Hispanic/Latinx families. StEP OUT will be delivered by a registered dietician/certified lactation counselor in coordination with the Long Island Jewish Medical Center Special Supplemental Nutrition Program for Women, Infants, and Children (LIJ WIC). The StEP OUT curriculum is based on the Starting Early Program (StEP), which uses didactic instruction, reflective discussion, interactive demonstrations, and hands-on practicing of skills to support prenatal nutrition and healthy early infant feeding practices. The details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and our Community Advisory Board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. Each session will conclude with a structured feedback discussion designed to elicit targets and strategies for further program adaptation. We will collect feasibility and acceptability data after each session and at the end of the five-session program for each cohort. The iterative intervention adaptation process will be complete once all participants rate the intervention as "acceptable" or higher and fidelity is 90% or higher. We anticipate meeting this benchmark after 3 cohorts but may need to recruit an additional cohort to test subsequent adaptations, if necessary.
- Conditions
- Child Obesity, Breast Feeding, Feeding Behavior, Nutrition, Healthy
- Being tested
- StEP OUT
- Medical subject headings
- Pediatric Obesity, Breast Feeding, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StEP OUTBehavioural
The details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and the community advisory board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. All sessions are designed to be supportive, educational, and interactive, with opportunities to practice skills and discuss feeding and parenting concerns.
| Study group | Role | What they receive |
|---|---|---|
| StEP OUT Intervention | Experimental | See intervention description Receives: Behavioral: StEP OUT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.
Measured: From enrollment through the end of the study after child age 4 months.
Feasibility
Feasibility assessment will include measures of recruitment (number enrolled of those eligible), retention (number who attend all scheduled sessions of those enrolled), fidelity (number of curriculun components delivered of those planned), and attendance (1. Attendance rate: number of participants who attend each sessions of those scheduled to attend; 2. Program dose: number of sessions attended for each participant)
Measured: From enrollment to study completion after infant age 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start10 Jun 2024
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child ObesityStudies of the same condition, open and under way.
- More trials run by Northwell 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
- Not applicable
- Intervention model
- Single group
- Model description
- Sequential, single arm, intervention development study.
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Katzow, Northwell Health
- Investigators
- Michelle W Katzow, MD, MS, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486922
- Sponsor's protocol ID
- 21-1078 Aim 2
- Status last verified
- Jul 2026
- First submitted
- 20 Jun 2024
- Last updated
- 24 Jul 2026
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
- ClinicalTrials.gov ID
- NCT06486922
- Acronym / sponsor ID
- 21-1078 Aim 2
- Conditions
- Child Obesity, Breast Feeding, Feeding Behavior, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 5 Jul 2024 (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.
The goal of this intervention development study is to optimize the Starting Early to Prevent Obesity Using Telehealth (StEP OUT) intervention for feasibility and acceptability, using human-centered design and community-engaged research methods.
Detailed description
This intervention development study will enroll three to four consecutive cohorts to receive Starting Early to Prevent Obesity Using Telehealth (StEP OUT), an online, group-based nutrition education and parenting support program beginning in the third trimester of pregnancy and continuing through the first four to six months of infancy. It is tailored to Hispanic/Latinx families. StEP OUT will be delivered by a registered dietician/certified lactation counselor in coordination with the Long Island Jewish Medical Center Special Supplemental Nutrition Program for Women, Infants, and Children (LIJ WIC). The StEP OUT curriculum is based on the Starting Early Program (StEP), which uses didactic instruction, reflective discussion, interactive demonstrations, and hands-on practicing of skills to support prenatal nutrition and healthy early infant feeding practices. The details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and our Community Advisory Board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. Each session will conclude with a structured feedback discussion designed to elicit targets and strategies for further program adaptation. We will collect feasibility and acceptability data after each session and at the end of the five-session program for each cohort. The iterative intervention adaptation process will be complete once all participants rate the intervention as "acceptable" or higher and fidelity is 90% or higher. We anticipate meeting this benchmark after 3 cohorts but may need to recruit an additional cohort to test subsequent adaptations, if necessary.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Sequential, single arm, intervention development study.
| Arm | Type | Receives |
|---|---|---|
| StEP OUT Intervention | Experimental | Behavioral: StEP OUTSee intervention description |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant with at least 14 weeks estimated gestational age
- Self-identify as Hispanic/Latinx
- Speak fluent English or Spanish
- At least 18 years of age
- Has a phone or device to participate in video calls
Key exclusion criteria (3 listed)
- Diminished mental capacity
- Serious medical or psychiatric illness
- Serious fetal illness
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 |
|---|---|---|
| StEP OUTThe details of program structure and content will evolve as the study progresses based on feedback from participants, interventionists, and the community advisory board. Initially, we will plan to have 5 formal sessions structured as groups with multiple participants receiving the session simultaneously, primarily via remote videoconference, though sessions may occur individually, based on participant schedule and preference. All sessions are designed to be supportive, educational, and interactive, with opportunities to practice skills and discuss feeding and parenting concerns. | Behavioural | StEP OUT Intervention |
Primary outcome
Acceptability
Time frame: From enrollment through the end of the study after child age 4 months.
We will use the Sekhon acceptability framework to assess affective attitude, burden, opportunity cost, perceived effectiveness, coherence, ethicality, self-efficacy and general acceptability.
Feasibility
Time frame: From enrollment to study completion after infant age 4 months.
Feasibility assessment will include measures of recruitment (number enrolled of those eligible), retention (number who attend all scheduled sessions of those enrolled), fidelity (number of curriculun components delivered of those planned), and attendance (1. Attendance rate: number of participants who attend each sessions of those scheduled to attend; 2. Program dose: number of sessions attended for each participant)
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 24 Jul 2026.
- 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.
Michelle W Katzow, MD, MS principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing StEP OUT in people with Child Obesity and Breast Feeding, run by Northwell 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 6 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 24 Jul 2026. 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?
Acceptability (time frame: From enrollment through the end of the study after child age 4 months.). 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 24 Jul 2026.