Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy

NCT03707834 | Completed Results DMC

• 2 other identifiers: 25256R01DK115939-01A1
• Study Type: interventional
• Target: 416
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Overweight; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Change in Dietary Intake

  Baseline and 36-38 weeks' gestation

• Percentage With Glucose Intolerance

  Delivery

• Percentage With Hypertension

  Delivery

• Change in Maternal 6-month Weight Postpartum (pp)

  At baseline and 6-month PP

• Change in Maternal 12-month Weight Postpartum (pp)

  At baseline and 12-month PP

Study Arms (2)

WIC Standard Care (SC)

NO INTERVENTION

Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.

Antenatal Obesity Treatment (AO)

EXPERIMENTAL

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)

Interventions

Antenatal Obesity Treatment (AO) BEHAVIORAL

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.

Antenatal Obesity Treatment (AO)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Temple University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Findings need to be considered in light of the Covid-19 pandemic, which led to challenges with intervention delivery and intensity (i.e., limited in-person WIC visits, structural impediments for system-wide adaptation) along with remote weight and height measures for some participants.

Results Point of Contact

• Title: Sharon J. Herring, MD, MPH, Principal Investigator
• Organization: Temple University

herris01@temple.edu

215-707-2234

Study Officials

• Sharon J Herring, MD, MPH

  Temple University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: October 16, 2018
• Study Start: July 1, 2018
• Primary Completion: October 10, 2023
• Study Completion: November 30, 2024
• Last Updated: January 21, 2026
• Results First Posted: January 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)