Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy (GWG)

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

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight; Pregnancy Related
• Intervention / Treatment: Behavioral: Antenatal Obesity Treatment (AO)

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.

• Study Type: Interventional
• Enrollment (Actual): 416
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: WIC Standard Care (SC); Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.
Experimental: Antenatal Obesity Treatment (AO); The AO arm consists of a multi-component, theory- and evidence-based intervention and includes weight-related behavior change through goal setting and self-monitoring, behavioral skills training, interpersonal support, and social modeling strategies.	Behavioral: Antenatal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Women With Excessive Gestational Weight Gain	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).	End of Pregnancy (36-38 weeks' gestation)
Change in Maternal Weight	Weight gain will be calculated as the difference between weight in kilograms measured at 36-38 weeks' gestation and baseline weight.	At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dietary Intake	Will 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.	Baseline and 36-38 weeks' gestation
Percentage With Glucose Intolerance	Evaluated via medical record abstraction	Delivery
Percentage With Hypertension	Evaluated via medical record abstraction	Delivery
Change in Maternal 6-month Weight Postpartum (pp)	Weight change will be calculated as the difference between mean 6-month PP weight and baseline weight in kilograms.	At baseline and 6-month PP
Change in Maternal 12-month Weight Postpartum (pp)	Weight change will be calculated as the difference between mean 12-month PP weight and baseline weight in kilograms.	At baseline and 12-month PP

Collaborators and Investigators

• Sponsor: Temple University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Sharon J Herring, MD, MPH, Temple University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): October 10, 2023
• Study Completion (Actual): November 30, 2024

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: October 11, 2018
• First Posted (Actual): October 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 3, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 25256; R01DK115939-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Dr. Herring (PI) will ensure that all publications that result from data collected as part of this project will comply with the NIH public access policy. Also, Dr. Herring agrees to develop a transportable de-identified database, codebook, and mechanism by which data can be shared with other investigators upon approval of the study's research team. The Resource Sharing Plan will be reviewed and approved by Temple University's Institutional Review Board.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No