ObesityGWGNCT03707834
Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
A study testing Antenatal Obesity Treatment (AO) in people with Obesity and Overweight, run by Temple University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight, Pregnancy Related
- What is being tested?
- Antenatal Obesity Treatment (AO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the effect of an antenatal obesity treatment on gestational weight gain when integrated into Philadelphia WIC.
Read the 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.
- Conditions
- Obesity, Overweight, Pregnancy Related
- Being tested
- Antenatal Obesity Treatment (AO)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antenatal Obesity Treatment (AO)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Antenatal Obesity Treatment (AO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation)
Secondary outcomes (5)
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.
Measured: Baseline and 36-38 weeks' gestation
Percentage With Glucose Intolerance
Evaluated via medical record abstraction
Measured: Delivery
Percentage With Hypertension
Evaluated via medical record abstraction
Measured: 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.
Measured: 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.
Measured: At baseline and 12-month PP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start1 Jul 2018
- Primary completion10 Oct 2023
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon J Herring, MD, MPH, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03707834
- Sponsor's protocol ID
- 25256
- Other IDs
- R01DK115939-01A1
- Acronym
- GWG
- Status last verified
- Jan 2026
- First submitted
- 13 Sep 2018
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
- ClinicalTrials.gov ID
- NCT03707834
- Acronym / sponsor ID
- GWG / 25256
- Conditions
- Obesity, Overweight, Pregnancy Related
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Antenatal Obesity Treatment (AO) |
Primary outcome
Percentage of Women With Excessive Gestational Weight Gain
Time frame: End 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 Weight
Time frame: At 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.
5 secondary outcomes
Change in Dietary Intake
Time frame: Baseline and 36-38 weeks' gestation
Percentage With Glucose Intolerance
Time frame: Delivery
Percentage With Hypertension
Time frame: Delivery
Change in Maternal 6-month Weight Postpartum (pp)
Time frame: At baseline and 6-month PP
Change in Maternal 12-month Weight Postpartum (pp)
Time frame: At baseline and 12-month PP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon J Herring, MD, MPH principal investigator
Temple University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antenatal Obesity Treatment (AO) in people with Obesity and Overweight, run by Temple University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Women With Excessive Gestational Weight Gain (time frame: End of Pregnancy (36-38 weeks' gestation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.