NCT05630482

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
825

participants targeted

Target at P75+ for not_applicable obesity

Timeline
14mo left

Started May 2023

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2023Jul 2027

First Submitted

Initial submission to the registry

November 9, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

May 15, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2027

Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4.2 years

First QC Date

November 9, 2022

Last Update Submit

April 9, 2026

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • BMI

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

    1 year

Secondary Outcomes (1)

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

    1 year

Study Arms (2)

Healthy Family Foundations Intervention

EXPERIMENTAL

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

Control Condition

ACTIVE COMPARATOR

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

Interventions

Healthy Family FoundationsBEHAVIORAL

Healthy Family Foundations Curriculum

Healthy Family Foundations Intervention
Standard of CareOTHER

Standard of Care

Control Condition

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Two-parent military families (one or more parents are active duty military)
  • Expecting a first child, through 7 months gestation

You may not qualify if:

  • Families will be excluded if both parents do not participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nellis Airforce Base

Nellis Air Force Base, Nevada, 89191, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Mark Feinberg, PhD

    Penn State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Hostetler, PhD

CONTACT

8148657375mxh14@psu.edu

Mark Feinberg, PhD

CONTACT

8148657375mef11@psu.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Control Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

November 9, 2022

First Posted

November 29, 2022

Study Start

May 15, 2023

Primary Completion (Estimated)

July 15, 2027

Study Completion (Estimated)

July 15, 2027

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)