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Antenatal Obesity Treatment (AO) for Pregnancy

Temple University, Philadelphia, PA
Pregnancy+3 More ConditionsAntenatal Obesity Treatment (AO) - Behavioral
Eligibility
18+
Female

Study Summary

This trial will test if an obesity treatment can help lower weight gain during pregnancy when given through the Women, Infants, and Children program in Philadelphia.

Eligible Conditions
  • Pregnancy
  • Obesity

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

2 Primary · 10 Secondary · Reporting Duration: 12-month PP

12-month PP
Infant length (12-month pp)
Infant weight (12-month pp)
6-month PP
Infant length (6-month pp)
Infant weight (6-month pp)
Week 38
Change in maternal weight
At baseline and 12-month PP
Change in maternal 12-month weight postpartum (pp)
At baseline and 6-month PP
Change in maternal 6-month weight postpartum (pp)
Week 38
Change in Dietary intake
Change in accelerometer-measured physical activity
Delivery
Proportion with glucose intolerance (mild hyperglycemia, gestational diabetes)
Proportion with hypertension
Week 38
Proportion of women with excessive gestational weight gain

Trial Safety

Phase-Based Safety

1 of 3

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Intervention Omega 3 Supplementation
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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

WIC Standard Care (SC)
1 of 2
Antenatal Obesity Treatment (AO)
1 of 2

Active Control

Experimental Treatment

438 Total Participants · 2 Treatment Groups

Primary Treatment: Antenatal Obesity Treatment (AO) · No Placebo Group · N/A

Antenatal Obesity Treatment (AO)
Behavioral
Experimental Group · 1 Intervention: Antenatal Obesity Treatment (AO) · Intervention Types: Behavioral
WIC Standard Care (SC)NoIntervention Group · 1 Intervention: WIC Standard Care (SC) · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12-month pp

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,213 Previous Clinical Trials
4,193,271 Total Patients Enrolled
Temple UniversityLead Sponsor
275 Previous Clinical Trials
74,973 Total Patients Enrolled
Sharon J Herring, MD, MPHPrincipal InvestigatorTemple University
2 Previous Clinical Trials
694 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a body mass index (BMI) of 25 kg/m2 or higher.
You consider yourself to be African American or Hispanic.
You are a participant in the Philadelphia Women, Infants, and Children (WIC) program.
You are okay with receiving text messages related to the study.
You have a cell phone with a text messaging plan that allows unlimited messages.
You are capable of doing light to moderate physical activity such as walking.
References

Frequently Asked Questions

Is this research program currently inviting participants to enroll?

"Clinicaltrials.gov's records indicate that this medical research is actively seeking participants, beginning with its listing on the 1st of July 2018 and then most recently updated on May 25th 2022." - Anonymous Online Contributor

Unverified Answer

What is the enrollment cap for this clinical trial?

"Affirmative, information hosted on clinicaltrials.gov reveals that this research is currently in need of participants. The study was initially posted on July 1st 2018 and last modified on May 25th 2022 - it seeks to enrol 438 patients from a single medical facility." - Anonymous Online Contributor

Unverified Answer

What key goals is this research attempting to achieve?

"The primary aim of this clinical trial is to measure the proportion of pregnant women who gain excessive gestational weight. Secondary goals include tracking changes in maternal postpartum weight, hypertension rates and infant length at 6 months old. Weight will be calculated using a calibrated scale while medical records are consulted for hypertension diagnoses and infants' lengths are measured at 6 months post-birth." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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