Randomized Trial of Healthy Family Foundations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Healthy Family Foundations, Standard of Care.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Adaptation of an Evidence-based Family Program for Obesity Prevention in Health Care Context
Overview
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.
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.
Interventions
- Behavioral Healthy Family Foundations
Healthy Family Foundations Curriculum - Other Standard of Care
Standard of Care
Primary outcome measures
- BMI [Time frame: 1 year]
Secondary outcome measures (1)
- Center for Epidemiologic Studies Depression Scale Revised (CESD-R-20) [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Nellis Airforce Base — Nellis Air Force Base
Identifiers
NCT: NCT05630482 · STUDY00020513 · R01DK133525