Recruiting

Healthy Family Foundations

Sponsor:

Penn State University

Code:

NCT05630482

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Healthy Family Foundations

Standard of Care

Study Details

Brief summary:

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 ID

NCT05630482

Start date

May 15, 2023

Status verified date

Apr, 2026

Completion date

Jul 15, 2027

Anticipated

Primary completion date

Jul 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

825 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Healthy Family Foundations

Healthy Family Foundations Curriculum

Standard of Care

Standard of Care

Primary outcome measure

  • BMI [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Michelle Hostetler, PhD

8148657375mxh14@psu.edu

Mark Feinberg, PhD

8148657375mef11@psu.edu

Locations

Nellis Airforce Base

Recruiting

Nellis Air Force Base, Nevada, United States, 89191

More Information

Sponsor

Penn State University

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Penn State University on 2026-04-14.