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Healthy Family Foundations Intervention for Obesity (HFF Trial)

N/A
Recruiting
Led By Mark Feinberg, PhD
Research Sponsored by Penn State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

HFF Trial Summary

This trial aims to see if a modified family-focused program can help reduce obesity in infants and parents in military families by improving support and coordination around healthy behaviors and parenting. Participants in the trial will either take

Who is the study for?
This trial is for two-parent military families where at least one parent is active duty and they are expecting their first child, up to the seventh month of pregnancy. It's designed to see if a special program can help prevent obesity in infants and parents by improving support between partners.Check my eligibility
What is being tested?
The study tests 'Healthy Family Foundations', a family-focused obesity prevention approach with online classes before and after birth, against standard care. The goal is to see if it affects infant weight gain, postpartum weight retention in mothers, fathers' weight status, coparenting support, mental health and health behaviors.See study design

HFF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
BMI
Secondary outcome measures
Center for Epidemiologic Studies Depression Scale Revised (CESD-R-20)

HFF Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Family Foundations InterventionExperimental Treatment1 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.
Group II: Control ConditionActive Control1 Intervention
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.

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Who is running the clinical trial?

Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
90,155 Total Patients Enrolled
1 Trials studying Obesity
120 Patients Enrolled for Obesity
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,359 Previous Clinical Trials
4,313,767 Total Patients Enrolled
446 Trials studying Obesity
588,113 Patients Enrolled for Obesity
Penn State UniversityLead Sponsor
355 Previous Clinical Trials
124,932 Total Patients Enrolled
20 Trials studying Obesity
7,108 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an age restriction that excludes individuals who are above 40 years old from participating in this clinical trial?

"Participants aged over 18 and under 60 are eligible for enrollment in this study."

Answered by AI

What are the eligibility criteria for individuals who can participate in this medical research study?

"This research study aims to recruit 825 individuals with obesity aged between 18 and 60. Specifically, eligible participants must belong to two-parent military households where at least one parent is actively serving in the military. Additionally, they should be expecting their first child up to the seventh month of gestation."

Answered by AI

What is the current number of individuals actively involved in this research endeavor?

"Affirmative. According to clinicaltrials.gov, this investigation is presently in the process of recruiting subjects. The trial was originally disclosed on May 15th, 2023, and last revised on February 2nd, 2024. It aims to enroll a total of 825 individuals at one location."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"Indeed, the details on clinicaltrials.gov show that this trial is in the active recruitment phase. The initial posting date was 15th of May, 2023 and the most recent update occurred on February 2nd, 2024. The research aims to enroll a total of 825 participants at one designated site."

Answered by AI

Who else is applying?

What site did they apply to?
Nellis Airforce Base
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Randomized Trial of Healthy Family Foundations
Mark Feinberg 2023. "Randomized Trial of Healthy Family Foundations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05630482.
~550 spots leftby Jul 2027
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