Clinical trial NCT06486922: Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
Official title: Starting Early to Prevent Obesity Using Telehealth (StEP OUT): Intervention Development Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Obesity
Breast Feeding
Feeding Behavior
Nutrition, Healthy
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Sequential, single arm, intervention development study.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Diminished mental capacity
* Serious medical or psychiatric illness
* Serious fetal illness

Primary outcomes:
measure: Acceptability
timeFrame: From enrollment through the end of the study after child age 4 months.
measure: Feasibility
timeFrame: From enrollment to study completion after infant age 4 months.
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Long Island Jewish Medical Center
state: New York
Study officials:
affiliation: Northwell Health
name: Michelle W Katzow, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: