No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
795 (estimated)
Sponsor
Stanford University · Other
Who this trial is looking for
This trial is looking for pregnant women to find out how different methods of providing nutrition and physical activity support can help manage weight during and after pregnancy. Participants will take part in study visits and activities from early pregnancy through 12 months after childbirth.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I am less than 20 weeks pregnant with one baby
I plan to continue my pregnancy to term
I will keep getting prenatal care at this site
I identify as Black/African American or Hispanic/Latino/a/e/x
I have Medicaid insurance
I can speak English or Spanish
I can complete the required surveys and measurements
You may not be able to join if
I am under 18 years old
I was underweight before my pregnancy
I have a health condition that affects my weight
I cannot attend study visits or complete the activities
I plan to move more than 100 miles from the study site
I am pregnant with more than one baby
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 postpartu…
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
Trial Locations
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Facility
City
State
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Status
Eligibility Criteria
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…
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
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