Randomized Trial of Healthy Family Foundations (HFF)

Adaptation of an Evidence-based Family Program for Obesity Prevention in Health Care Context

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity
• Intervention / Treatment: Other: Standard of Care; Behavioral: Healthy Family Foundations

Detailed Description

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.

Aim 1. To assess the efficacy of the adapted HFF program with 275 military families from health centers at military bases in Washington, Florida, and Nevada. Families with an active-duty servicemember parent will be randomized to Healthy Family Foundations (HFF) or control condition. Primary outcomes consist of infant weight status (weight-for-length z-score) and maternal postpartum weight retention through 12 months; fathers' change in weight to 12 months is a secondary outcome.

Aim 2. To test mediation: HFF will foster healthy (A) parent weight outcomes via mutual parental support around healthy lifestyle behaviors (physical activity, nutrition, sleep); and (B) child weight status via coparenting support for health-related parenting (responsive feeding and promotion of sleep, physical activity, stress regulation).

Aim 3. To assess whether baseline parent characteristics (financial stress, mental health, relationship conflict, or weight status) or participant program engagement moderate program effects.

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.

• Study Type: Interventional
• Enrollment (Estimated): 825
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Hostetler, PhD; Phone Number: 8148657375; Email: mxh14@psu.edu
• Study Contact Backup: Name: Mark Feinberg, PhD; Phone Number: 8148657375; Email: mef11@psu.edu

Study Locations

• United States
  • Nevada
    • Nellis Air Force Base, Nevada, United States, 89191
      • Recruiting
      • Nellis Airforce Base
      • Contact: Lauren Cafferty

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Healthy Family Foundations; Healthy Family Foundations Curriculum
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.	Other: Standard of Care; Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	weight and height will be combined to report BMI in kg/m^2	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); State University of New York at Buffalo; Uniformed Services University of the Health Sciences
• Investigators: Principal Investigator: Mark Feinberg, PhD, Penn State University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2023
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): July 15, 2027

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: STUDY00020513; R01DK133525 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No