Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy

Obesity Clinical Trial

— GWG  

Official title:

Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03707834
• Other study ID #: 25256
• Secondary ID: R01DK115939-01A1
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: Temple University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 416
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight
• Pregnancy Related
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	Temple University	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Temple University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women with excessive gestational weight gain	Excessive weight gain is defined as gaining above the upper end of IOM total weight gain ranges for singleton pregnancies (>11.5 kg for overweight BMI; >9 kg for obese BMI). Weight will be measured using a calibrated scale at baseline and 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.	End of Pregnancy (36-38 weeks' gestation)
Primary	Change in maternal weight	Weight will be measured using a calibrated scale at baseline and 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.	At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation)
Secondary	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
Secondary	Change in accelerometer-measured physical activity	Will be assessed at baseline and 36-38 weeks' gestation using accelerometers (ActiGraph GT3X+), worn on participants' hip for 7 days.	Baseline and 36-38 weeks' gestation
Secondary	Proportion with glucose intolerance (mild hyperglycemia, gestational diabetes)	Evaluated via medical record abstraction	Delivery
Secondary	Proportion with hypertension	Evaluated via medical record abstraction	Delivery
Secondary	Change in maternal 6-month weight postpartum (pp)	Weight will be measured using a calibrated scale at baseline and 6-month postpartum(PP). Weight loss will be calculated as the difference between mean 6-month PP and baseline weight in kilograms.	At baseline and 6-month PP
Secondary	Change in maternal 12-month weight postpartum (pp)	Weight will be measured using a calibrated scale at baseline and 12-month PP. Weight loss will be calculated as the difference between mean 12-month PP and baseline weight in kilograms.	At baseline and 12-month PP
Secondary	Infant weight (6-month pp)	Infant weight will be measured at 6-months of age to assess maintenance of intervention effects on infant weight.	6-month PP
Secondary	Infant length (6-month pp)	Infant length will be measured at 6-months of age to assess maintenance of intervention effects on infant length.	6-month PP
Secondary	Infant weight (12-month pp)	Infant weight will be measured at 12-months of age to assess maintenance of intervention effects on infant weight.	12-month PP
Secondary	Infant length (12-month pp)	Infant length will be measured at 12-months of age to assess maintenance of intervention effects on infant length.	12-month PP