Randomized Trial of Healthy Family Foundations
ConditionObesity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPenn State University
About this trial
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.
Eligibility criteria
Qualifiers
Two-parent military families (one or more parents are active duty military)
Expecting a first child, through 7 months gestation
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Healthy Family Foundations
- Standard of Care
Treatment groups
825 Participants
are divided into 2 treatment groupsSponsors and collaborators
Penn State University
Lead sponsor
Uniformed Services University of the Health Sciences
Collaborator
State University of New York at Buffalo
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov