[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05630482":3,"trial-entities:NCT05630482":88,"trial-summary:NCT05630482":91},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":51,"eligibility_criteria":52,"std_ages":59,"locations":61,"central_contacts":75,"overall_officials":83,"references":86,"see_also_links":87},"NCT05630482","STUDY00020513","Randomized Trial of Healthy Family Foundations","Adaptation of an Evidence-based Family Program for Obesity Prevention in Health Care Context","RECRUITING","2027-07-15","2026-04","2026-04-14","2023-05-15","Penn State University","OTHER",false,"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.\n\nThe 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.\n\nParticipants randomized to the Healthy Family Foundations (HFF) intervention condition will participate in 10 online group classes (5 prenatal and 5 postnatal).\n\nParticipants randomized to the control condition will receive standard of care and opportunities for education at their site.\n\nResearchers 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.","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.\n\nThe 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.\n\nAim 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.\n\nAim 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).\n\nAim 3. To assess whether baseline parent characteristics (financial stress, mental health, relationship conflict, or weight status) or participant program engagement moderate program effects.\n\nParticipants randomized to the Healthy Family Foundations (HFF) intervention condition will participate in 10 online group classes (5 prenatal and 5 postnatal).\n\nParticipants randomized to the control condition will receive standard of care and opportunities for education at their site.\n\nResearchers 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.",[19],"Obesity",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},825,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","Healthy Family Foundations","Healthy Family Foundations Curriculum",[34],"Healthy Family Foundations Intervention",{"type":14,"name":36,"description":36,"armGroupLabels":37},"Standard of Care",[38],"Control Condition",[40],{"measure":41,"description":42,"timeFrame":43},"BMI","weight and height will be combined to report BMI in kg\u002Fm\\^2","1 year",[45],{"measure":46,"description":47,"timeFrame":43},"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.","ALL","18 Years","60 Years",true,{"inclusion":53,"exclusion":56,"raw_text":58},[54,55],"Two-parent military families (one or more parents are active duty military)","Expecting a first child, through 7 months gestation",[57],"Families will be excluded if both parents do not participate.","Inclusion Criteria:\n\n* Two-parent military families (one or more parents are active duty military)\n* Expecting a first child, through 7 months gestation\n\nExclusion Criteria:\n\n* 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)\n* Families will be excluded if both parents do not participate.",[60],"ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":72},"Nellis Airforce Base","Nellis Air Force Base","Nevada","89191","United States",[69],{"name":70,"role":71},"Lauren Cafferty","CONTACT",{"lat":73,"lon":74},36.24607,-115.05721,[76,80],{"name":77,"role":71,"phone":78,"email":79},"Michelle Hostetler, PhD","8148657375","mxh14@psu.edu",{"name":81,"role":71,"phone":78,"email":82},"Mark Feinberg, PhD","mef11@psu.edu",[84],{"name":81,"affiliation":13,"role":85},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":89,"biomarkers":90},[19],[],{"nct_id":4,"found":51,"summary":92,"prompt_version":102},{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is an interventional study that will randomly assign participants to either the Healthy Family Foundations program or standard care. It plans to enroll 825 participants.","completed","Healthy Family Foundations for Military Families","This study, called Healthy Family Foundations, is testing a program designed to help military families prevent obesity in infants and parents. It aims to see if an adapted program can reduce rapid infant weight gain, new mothers' weight after childbirth, and fathers' weight. You might be able to join if you are in a two-parent military family, expecting your first child (up to 7 months pregnant), and are between 18 and 60 years old. The study will compare the Healthy Family Foundations program to standard care. The main goal is to measure changes in body mass index (BMI) after one year. The study is currently unclear on its recruitment status and plans to enroll 825 families.","Your BMI will be measured at 1 year after joining the study.",116,"Participants in the Healthy Family Foundations group will take part in 10 online group classes (5 before birth and 5 after birth).","Not stated in the trial record.",[31],"v2"]