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

Disqualifiers: Over 18 weeks pregnant, others

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?

This trial aims to determine if providing pregnant women with funds specifically for healthy food reduces excessive weight gain during pregnancy. Participants will be divided into two groups: one will receive the Enhanced Standard of Care (ESoC) with nutritional advice and support programs, while the other will receive the same plus additional funds for healthy food. Women who are less than 18 weeks pregnant and speak English, Spanish, or Marshallese are eligible candidates. The focus is on understanding how better access to healthy food can improve pregnancy health outcomes. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance pregnancy health for many women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that lifestyle changes during pregnancy, such as those in the Delivering HOPE program, can help manage weight gain. Studies have found that these changes often lead to better weight control and healthier pregnancy outcomes. No evidence suggests harm from these programs, as they focus on healthy eating and lifestyle habits.

In past studies, participants did not report any major negative effects from receiving financial help to buy healthy foods. It's like having a budget just for nutritious groceries, which many find useful without any downsides. This suggests that the Delivering HOPE program is likely safe and well-received by pregnant women. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Delivering HOPE because it adds a financial incentive to traditional nutritional counseling for pregnant women. Unlike the standard care, which mainly offers counseling and assistance with programs like WIC and SNAP, Delivering HOPE provides extra funds specifically for purchasing healthy foods based on household size. This unique approach not only emphasizes education but also empowers participants to make healthier food choices, potentially improving outcomes for both mother and baby.

What evidence suggests that this trial's treatments could be effective for reducing excessive gestational weight gain?

Studies have shown that providing healthy food during pregnancy can help manage gestational weight gain (GWG). Research indicates that improving nutrition during pregnancy can control this weight gain and lead to better pregnancy outcomes. For example, a study comparing different nutrition programs found that those offering healthy foods specifically helped prevent excessive weight gain. Nutrition counseling, included in these programs, has improved diet and kept weight gain within healthy limits during pregnancy. In this trial, the Delivering HOPE arm includes financial support for buying healthy food, which may effectively reduce excessive weight gain in pregnant women. Meanwhile, the Enhanced Standard of Care (ESoC) arm provides standard nutritional and gestational weight gain counseling, along with assistance for WIC and SNAP enrollment and referrals to food organizations. ^{2 3 4 6 7}

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+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Citations

1. pcori.org pcori.org/research-results/2023/comparing-two-multi-level-nutritional-interventions-prevent-excessive-gestational-weight-gain-pregnancy

Comparing Two Multi-Level Nutritional Interventions To ... This study compares the clinical effectiveness of two multi-level interventions to determine if the provision of healthy food versus ...

2. withpower.com withpower.com/trial/delivering-hope-for-gestational-weight-gain-d28a4

Delivering HOPE for Gestational Weight Gain Data for the primary outcome (pre-pregnancy weight and weight at delivery) will be collected from birth records. Show more. Who Is on the Research Team? PM.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10276313/

Key Components of Antenatal Lifestyle Interventions to ... Randomized clinical trials have found that antenatal lifestyle interventions optimize gestational weight gain (GWG) and pregnancy outcomes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10687348/

Effectiveness of nutrition counseling for pregnant women in low Nutrition counseling may improve dietary caloric intake, protein and fat intake, and gestational weight gain within health recommendations and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT02711644

Promoting Healthy Weights, Lifestyles and Nutrition in ... Data will be collected on diet, physical activity, gestational weight gain, delivery, and infant outcomes. After this research is complete, the investigators ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06814509

Delivering HOPE (Helping Women Optimize Prenatal Equity) The ESoC arm includes implementing a standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women; ...

7. mdpi.com mdpi.com/2077-0383/12/9/3211

Excessive Gestational Weight Gain and Pregnancy ... Excessive weight gain during pregnancy is linked to higher birth weight, higher risk of cesarean section, hypertension, and lower Apgar scores.