RECRUITING
I'm interested ...!!
Randomized Trial of Healthy Family Foundations
The goal of this clinical trial is to test whether an adaptation of an evidence-based, couple-based preventive intervention at the transition to parenthood improves reduces obesity risk among infants and parents in military families via improved interparental support and coordination around health lifestyle behaviors and parenting. The main question it aims to answer is whether an adapted, innovative family-focused approach to obesity prevention can reduce rapid infant weight gain, new mothers' postpartum weight retention, and fathers' weight status. Participants randomized to the Healthy Family Foundations (HFF) intervention condition will participate in 10 online group classes (5 prenatal and 5 postnatal). Participants randomized to the control condition will receive standard of care and opportunities for education at their site. Researchers will compare the Healthy Family Foundations (HFF) intervention group with a Standard of Care control group to see if there are differences in weight, coparenting support, parent mental health and parent health behaviors.
Conditions:
🦠 Obesity
🗓️ Study Start (Actual) 15 May 2023
🗓️ Primary Completion (Estimated) 15 July 2027
✅ Study Completion (Estimated) 15 July 2027
👥 Enrollment (Estimated) 825
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Nellis Air Force Base, Nevada, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Two-parent military families (one or more parents are active duty military)
    • * Expecting a first child, through 7 months gestation

    Exclusion Criteria:

    • * Clinical exclusion criteria for parents apply to males and females (active diagnosis of cancer, AIDS, palliative medicine patients, malabsorptive conditions, uncontrolled multiple sclerosis, and severe cognitive impairment), and to females (multiple gestation)
    • * Families will be excluded if both parents do not participate.
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 November 2022
  • First Submitted that Met QC Criteria 18 November 2022
  • First Posted 29 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 2 February 2024
  • Last Update Posted 5 February 2024
  • Last Verified February 2024
I'm interested ...!!