Delivering HOPE for Gestational Weight Gain

Recruiting at 7 trial locations

Overseen By Sarah Pollock

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 40 weeks

1440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The overarching research question is: "Does the provision of healthy food (Delivering HOPE) during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with enhanced standard of care (ESoC)?" To answer this question, the investigators will conduct a large multi-site randomized controlled trial with 1,440 women. Women will be randomized to either the Delivering HOPE arm or the ESoC arm, with approximately 720 participants per arm. Participants randomized to the ESoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, WIC and SNAP enrollment assistance, referrals to safety net food organizations.Those randomized to the Delivering HOPE arm will be provided the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals, as well as a total of $1000/$2000/$3000 (depending on household size) during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records.

Who Is on the Research Team?

Pearl McElfish, PhD

Principal Investigator

University of Arkansas

Lanita White, PharmD

Principal Investigator

Community Health Centers of Arkansas

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 16-44, who are less than or equal to 18 weeks along. It's designed to help those at risk of complications like excessive weight gain, hypertension, and diabetes by promoting healthy eating.

Inclusion Criteria

I am between 16 and 44 years old.

I am less than or equal to 18 weeks pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutritional and gestational weight gain counseling, WIC and SNAP assistance, and food referrals. Delivering HOPE arm participants receive funds for healthy food purchases.

40 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, with data collected from birth records.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delivering HOPE
• Enhanced Standard of Care (ESoC)

Trial Overview The study compares two approaches: 'Delivering HOPE', which provides up to $3000 for buying healthy foods during pregnancy based on household size, versus an 'Enhanced Standard of Care' that includes typical nutritional counseling and assistance programs.

How Is the Trial Designed?

Group I: Delivering HOPE Experimental Treatment 1 Intervention

The Delivering HOPE arm includes providing the same nutritional and gestational weight gain counseling, WIC and SNAP assistance, and referral assistance as ESoC. In addition, participants in the Delivering HOPE arm will be provided with funds during their pregnancy to be used specifically for the purchase of healthy foods. The amount will vary based on household size as follows: $1,000 (one to two household members), $2,000 (three to four household members), or $3,000 (five plus household members).

Group II: Enhanced Standard of Care (ESoC) Active Control 1 Intervention

The ESoC arm includes implementing a standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women; implementing a standard protocol for helping participants sign up for WIC and SNAP; and implementing a standard protocol for providing referrals to safety net food organizations.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+