Clinical trial NCT03707834: Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
Official title: Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Pregnancy Related
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-10-16
Enrollment: 416
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of women with excessive gestational weight gain
timeFrame: End of Pregnancy (36-38 weeks' gestation)
measure: Change in maternal weight
timeFrame: At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation)
Secondary outcomes:
measure: Change in Dietary intake
timeFrame: Baseline and 36-38 weeks' gestation
measure: Change in accelerometer-measured physical activity
timeFrame: Baseline and 36-38 weeks' gestation
measure: Proportion with glucose intolerance (mild hyperglycemia, gestational diabetes)
timeFrame: Delivery
measure: Proportion with hypertension
timeFrame: Delivery
measure: Change in maternal 6-month weight postpartum (pp)
timeFrame: At baseline and 6-month PP
measure: Change in maternal 12-month weight postpartum (pp)
timeFrame: At baseline and 12-month PP
measure: Infant weight (6-month pp)
timeFrame: 6-month PP
measure: Infant length (6-month pp)
timeFrame: 6-month PP
measure: Infant weight (12-month pp)
timeFrame: 12-month PP
measure: Infant length (12-month pp)
timeFrame: 12-month PP
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Sharon J Herring, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: