Randomized Trial of Healthy Family Foundations

Obesity Clinical Trial

— HFF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05630482
• Other study ID #: STUDY00020513
• Secondary ID: R01DK133525
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: July 15, 2027

Study information

• Verified date: February 2024
• Source: Penn State University
• Contact: Michelle Hostetler, PhD
• Phone: 8148657375
• Email: mxh14[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 825
• Est. completion date: July 15, 2027
• Est. primary completion date: July 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obesity

Intervention

Behavioral:
• Healthy Family Foundations
Healthy Family Foundations Curriculum

Other:
• Standard of Care
Standard of Care

Locations

Country	Name	City	State
United States	Nellis Airforce Base	Nellis Air Force Base	Nevada

Sponsors (4)

Lead Sponsor	Collaborator
Penn State University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), State University of New York at Buffalo, Uniformed Services University of the Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	weight and height will be combined to report BMI in kg/m^2	1 year
Secondary	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