Chronic Disease, Diabetes, Nutrition, Obesity and Overweight, Pregnancy
Conditions
Brief summary
The goal of this comparative effectiveness trial is to compare how three different approaches to overcome barriers to resources and provide nutrition and physical activity counseling improve maternal healthy weight in pregnancy and postpartum. The main question it aims to answer is which of the two multi-level, multi-component interventions has greater effectiveness in reducing maternal postpartum weight retention at 12-months postpartum. Hypothesis (primary): Both multi-level, multi-component interventions will have greater effectiveness reducing maternal postpartum weight retention at 12-months postpartum than the usual care group. Hypothesis (secondary): The community-based intervention will have greater effectiveness than the self-management intervention. Participants will be asked to participate in one of the study interventions from early pregnancy until 12 months postpartum and complete five research visits. General procedures include completion of: * Questionnaires * Dietary recalls * In-depth interviews * Anthropometric measurements * Collection of blood via finger stick or blood panel
Interventions
BEHAVIORALSelf-Management
We will universally offer social needs supports (grocery, physical activity, transportation support) widely in use in clinical settings. Patients may elect to receive all, some, or none of the supports. The patient-directed, structured self-management intervention will be provided through mobile health technology (mHealth) and/or mailings, according to patient preference. Participants will receive health information to support health education and behavior change.
BEHAVIORALCommunity-Based
As is currently in use broadly by community health workers, participants will complete a detailed social needs assessment and active assistance with referrals to evidence-based home visiting programs; maternal child health services to promote social support and resource access; and services to improve social determinants of health including active enrollment assistance for WIC, SNAP, healthcare and insurance, legal support, housing, job training, mental health and others. Community health workers will deliver group and individual physical activity support and assistance with behavioral goal setting.
Sponsors
Stanford University
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Maternal age 18 years or older * Maternal gestational age ≤ 20 weeks with viable singleton pregnancy documented on first trimester ultrasound with an intention to continue pregnancy to term * Plans to continue receiving antenatal care at the recruitment site/network * Maternal characteristics include at least one of the following: * Self identifies as Black/African American * Self identifies as Hispanic/Latino/a/e/x * Insured by Medicaid * Maternal ability to speak English or Spanish * Completion of baseline data collection (maternal survey data, weight, and height measurement prior to randomization)
Exclusion criteria
* Age \< 18 years at baseline because of unique developmental differences of adolescents and regulations regarding age of consent * Underweight (BMI \<18 kg/m2) at pre-pregnancy period * Underlying disease/treatment that might impact weight status (e.g., significant gastrointestinal conditions, major psychiatric disorders, and others at the discretion of the study clinician) * Unwillingness or inability to complete study visits or intervention components * Unwillingness or inability to commit to intervention components for self or infant, including plans to move more than 100-mile radius from recruitment site * Multiple gestations
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal postpartum weight retention at 12-months postpartum. | From enrollment to the end of the intervention at 12 months postpartum. | The primary outcome will be calculated as the difference between baseline weight and 12-month postpartum weight. Baseline weight will be defined as the first clinical measure of maternal weight prior to 12 weeks gestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Household social needs and maternal perinatal health outcomes | From enrollment to the end of the intervention at 12 months postpartum. | We will obtain patient self-reported measures where applicable for secondary outcomes through validated questionnaires. Secondary outcomes include household food security, gestational weight gain, gestational diabetes, with maternal race and ethnicity and pre-pregnancy body mass index category as effect modifiers. |
Countries
United States
Contacts
CONTACTJennifer Woo Baidal Associate Professor, MD, MPH
Outcome results
None listed