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Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy (GWG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03707834
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Temple University

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.

Condition or disease Intervention/treatment Phase
Obesity Overweight Pregnancy Related Behavioral: Antenatal Obesity Treatment (AO) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Partnering With WIC to Prevent Excessive Weight Gain in Pregnancy
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : June 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
No Intervention: WIC Standard Care (SC)
Participants assigned to the WIC standard care arm will receive usual care offered to pregnant women at WIC.
Experimental: 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.
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.




Primary Outcome Measures :
  1. Proportion of women with excessive gestational weight gain [ Time Frame: End of Pregnancy (36-38 weeks' gestation) ]
    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.

  2. Change in maternal weight [ Time Frame: At baseline (<16 weeks' gestation) and End of Pregnancy (36-38 weeks' gestation) ]
    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.


Secondary Outcome Measures :
  1. Change in Dietary intake [ Time Frame: Baseline and 36-38 weeks' gestation ]
    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.

  2. Change in accelerometer-measured physical activity [ Time Frame: Baseline and 36-38 weeks' gestation ]
    Will be assessed at baseline and 36-38 weeks' gestation using accelerometers (ActiGraph GT3X+), worn on participants' hip for 7 days.

  3. Proportion with glucose intolerance (mild hyperglycemia, gestational diabetes) [ Time Frame: Delivery ]
    Evaluated via medical record abstraction

  4. Proportion with hypertension [ Time Frame: Delivery ]
    Evaluated via medical record abstraction

  5. Change in maternal 6-month weight postpartum (pp) [ Time Frame: At baseline and 6-month 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.

  6. Change in maternal 12-month weight postpartum (pp) [ Time Frame: At baseline and 12-month 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.

  7. Infant weight (6-month pp) [ Time Frame: 6-month PP ]
    Infant weight will be measured at 6-months of age to assess maintenance of intervention effects on infant weight.

  8. Infant length (6-month pp) [ Time Frame: 6-month PP ]
    Infant length will be measured at 6-months of age to assess maintenance of intervention effects on infant length.

  9. Infant weight (12-month pp) [ Time Frame: 12-month PP ]
    Infant weight will be measured at 12-months of age to assess maintenance of intervention effects on infant weight.

  10. Infant length (12-month pp) [ Time Frame: 12-month PP ]
    Infant length will be measured at 12-months of age to assess maintenance of intervention effects on infant length.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03707834


Contacts
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Contact: Sharon J Herring, MD, MPH 2157072234 sharon.herring@temple.edu
Contact: Jessica J Albert, BA 2157073292 jjw222@temple.edu

Locations
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United States, Pennsylvania
Temple University Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Sharon J Herring, MD, MPH    215-707-2234    Sharon.Herring@temple.edu   
Contact: Jessica Albert, BA    215-707-3292    jjw222@temple.edu   
Principal Investigator: Sharon J. Herring, MD, MPH         
Sponsors and Collaborators
Temple University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Sharon J Herring, MD, MPH Temple University
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Responsible Party: Temple University
ClinicalTrials.gov Identifier: NCT03707834    
Other Study ID Numbers: 25256
R01DK115939-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Weight Gain
Body Weight
Body Weight Changes