Health TrialsbyHealthPanel

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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Healthy Family Foundations

    Behavioral

    Healthy Family Foundations Curriculum

  • Standard of Care

    Other intervention

    Standard of Care

Treatment groups

825 Participants
are divided into 2 treatment groups
Group A: Healthy Family Foundations InterventionExperimental treatment 1 intervention
Group B: Control ConditionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

BMI

weight and height will be combined to report BMI in kg/m\^2

Time frame
1 year

Secondary outcomes

1

Center for Epidemiologic Studies Depression Scale Revised (CESD-R-20)

The Center for Epidemiologic Studies Depression Scale (CESD). Scores range from 0-60, with higher scores indicating more depressive symptomatology.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
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