Randomized Trial of Healthy Family Foundations

Part of paid clinical trials in Nellis Air Force Base, Nevada.

Sponsor
Penn State University
Study ID
NCT05630482
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • Healthy Family Foundations — BEHAVIORAL
    Healthy Family Foundations Curriculum
  • Standard of Care — OTHER
    Standard of Care

Study Details

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.

Key Dates

Start date
May 15, 2023
Status verified
Apr 2026
Primary completion
Jul 15, 2027
Completion
Jul 15, 2027

Study Design

Enrollment
825 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Healthy Family Foundations Intervention
    Participants randomized to the HFF intervention condition will participate in 10 weekly 2 hour classes (5 prenatal and 5 postnatal) in groups of 5-10 couples. Due to COVID, all classes will take place via Zoom. The classes will be led by male/female facilitator teams. The facilitators will be hired, trained and supervised by Penn State. Postnatal classes will occur 2-8 months after birth and will also be weekly and last 2 hours each.
  • Active Comparator: Control Condition
    Participants randomized to the control condition will receive standard of care and opportunities for education at their site, including information about infant growth and development, infant care (including brief, standard information regarding breastfeeding/introduction to solid food), and quality childcare selection.

Primary Outcome Measure

BMI [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nellis Airforce BaseNellis Air Force BaseNevada89191
Lauren Cafferty

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Nellis Airforce Base· Nellis Air Force Base, NV

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