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Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy

Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03707834
Acronym
GWG
Enrollment
416
Registered
2018-10-16
Start date
2018-07-01
Completion date
2024-11-30
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight, Pregnancy Related

Brief summary

The purpose of this study is to determine the effect of an antenatal obesity treatment on gestational weight gain when integrated into Philadelphia WIC.

Detailed description

Institute of Medicine (IOM) guidelines for weight gain in pregnancy are clear, but evidence-based treatment approaches are not widely available. This evidence gap is particularly pressing for medically vulnerable women - those who are low income and often racial/ethnic minorities. These women have the highest rates of obesity, but almost no resources to support weight control in pregnancy. Without intervention, most will exceed Institute of Medicine recommended gains and incur significant morbidity for themselves and their children. There is preliminary data from the investigators supporting the efficacy of digital health platforms for delivering antenatal obesity treatment among the medically vulnerable. However, the investigators' inexpensive, easily scalable approach has not been integrated and tested in real world settings, limiting broad reach and dissemination potential. Dissemination considerations are especially pressing for socioeconomically disadvantaged and minority populations because of these groups' higher obesity risk, greater potential for experiencing obesity-related comorbidities in pregnancy, and limited finances to afford alternative treatments. The Women, Infants and Children (WIC) Food and Nutrition Program is the leading public health nutrition program for pregnant women and their children in the US, and thus, it is in a unique position to meaningfully impact the obesity epidemic among the more than 9 million disadvantaged participants it serves annually. Yet no demonstrations of effective gestational weight gain interventions exist in WIC. The investigators propose a pragmatic trial designed to rigorously test their antenatal obesity treatment approach integrated into Philadelphia WIC community clinics. The investigators have long-standing relationships with WIC staff and prior experience conducting pragmatic clinical trials in under-resourced settings. The investigators will randomize 438 African American and Hispanic Philadelphia County WIC participants with obesity in early pregnancy to one of two treatment arms: 1) standard WIC care; or 2) an antenatal obesity treatment arm, which includes empirically supported behavior change goals, regular self-monitoring text messages with automated feedback, tailored skills training materials, and counseling from WIC nutritionists. The primary outcome is prevalence of excessive gestational weight gain; the investigators will additionally examine changes in diet and physical activity, health-related quality of life, and rates of adverse pregnancy outcomes. They will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework to evaluate the intervention's dissemination potential and cost effectiveness in the WIC setting. The proposed project will constitute the first systematic translation of a comprehensive antenatal obesity treatment program focused on low-income, racial/ethnic minorities, using the strengths of mHealth (mobile health) and WIC provider counseling for intervention delivery.

Interventions

BEHAVIORALAntenatal Obesity Treatment (AO)

Participants in the treatment (AO) arm will receive a 4-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; and 4)WIC provider counseling Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.

Sponsors

Temple University
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* BMI ≥ 25 kg/m2 * Self-identify as African American or Hispanic * Gestational age ≤16 weeks' (measured using last menstrual period) * Philadelphia WIC participant * Willingness to receive study texts * Own a cell phone with an unlimited text messaging plan * Able to participate in light to moderate physical activity (walking)

Exclusion criteria

* Prior bariatric surgery * Pre-existing medical condition that could influence weight (e.g., diabetes, HIV, thyroid disorder, bulimia, anorexia, gallbladder disease) * Diagnosis contraindicating weight control (e.g., hyperemesis gravidarum) * Shared phone * Multiple pregnancy (e.g., twins) * Current and/or previous participant for our Temple-led obesity treatment interventions in pregnancy or the postpartum period * Serious or unstable medical or psychological conditions that, in the opinion of the PI, would compromise the subject's safety for successful participation in the study

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Women With Excessive Gestational Weight GainEnd of Pregnancy (36-38 weeks' gestation)Excessive weight gain is defined as the percentage of mothers exceeding weekly IOM weight gain targets (\>0.32 kg/week for BMI 25-29.9 kg/m2; \>0.27 kg/week for BMI ≥30 kg/m2) over the study period (from enrollment to end of pregnancy).
Change in Maternal WeightAt baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation)Weight gain will be calculated as the difference between weight in kilograms measured at 36-38 weeks' gestation and baseline weight.

Secondary

MeasureTime frameDescription
Change in Dietary IntakeBaseline and 36-38 weeks' gestationWill be measured using the Automated Self-Administered 24-hour (ASA24) dietary assessment tool, a web application developed by NCI. We will collect 3 separate 24-hour dietary recalls (1 weekend day, 2 weekdays) at baseline and 36-38 weeks' gestation.
Percentage With Glucose IntoleranceDeliveryEvaluated via medical record abstraction
Percentage With HypertensionDeliveryEvaluated via medical record abstraction
Change in Maternal 6-month Weight Postpartum (pp)At baseline and 6-month PPWeight change will be calculated as the difference between mean 6-month PP weight and baseline weight in kilograms.
Change in Maternal 12-month Weight Postpartum (pp)At baseline and 12-month PPWeight change will be calculated as the difference between mean 12-month PP weight and baseline weight in kilograms.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORSharon J Herring, MD, MPH

Temple University

Baseline characteristics

Characteristic
Age, Continuous29.7 years
STANDARD_DEVIATION 5.6
BMI, Categorical: 25-29.9 kg/m^2 (with overweight); >=30 kg/m2 (with obesity)
BMI 25-29.9 kg/m^2 (with overweight)
57 Participants
BMI, Categorical: 25-29.9 kg/m^2 (with overweight); >=30 kg/m2 (with obesity)
BMI >=30 kg/m^2 (with obesity)
152 Participants
Education: More than High School, High School and Below
High School and Below
223 Participants
Education: More than High School, High School and Below
More than High School
193 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
136 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
137 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Gestational Age, Continuous15.4 weeks
STANDARD_DEVIATION 2.4
Parity: Nulliparous, Primi- & Multiparous
Nulliparous
53 Participants
Parity: Nulliparous, Primi- & Multiparous
Primi- & Multiparous
135 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
292 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
56 Participants
Race (NIH/OMB)
White
5 Participants
Region of Enrollment
United States
209 Participants
Sex: Female, Male
Female
207 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 2070 / 209
other
Total, other adverse events
0 / 2070 / 209
serious
Total, serious adverse events
0 / 2070 / 209

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026