Food Provision for Gestational Weight Gain

(FPPC Trial)

Overseen By Kelsey Bounds

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Arkansas

Disqualifiers: Over 22 weeks pregnant, others

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

Compensation: Varies

Number of Visits: 24

Duration: Approximately 36 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if providing healthy food to pregnant women can prevent excessive weight gain during pregnancy. It includes two groups: one will receive standard pregnancy nutrition advice, while the other will receive the same advice plus extra money for healthy foods. Women up to 22 weeks pregnant, living in Arkansas, and planning to give birth there may qualify for this trial. As an unphased trial, this study offers a unique opportunity to contribute to important research that could enhance pregnancy health for many women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the Food Provision intervention is safe for pregnant women?

A previous study found that providing healthy foods during pregnancy can meet increased energy needs for weight gain without excess. This ensures a balanced and nutritious diet, important for healthy birth outcomes. Research has shown that good nutrition during pregnancy is crucial and benefits both the mother and baby's health.

Since the trial involves providing food rather than a new drug or medical procedure, the risk of negative effects is very low. No reports of side effects have emerged from simply providing healthy foods. Therefore, this approach is considered safe and well-tolerated. Participants can feel confident about the safety of receiving food provisions as part of this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to managing gestational weight gain by providing pregnant women with financial support specifically for purchasing healthy foods. Unlike the standard care that primarily involves nutritional counseling, this method adds a practical component by directly facilitating access to nutritious food, which can help ensure better health outcomes for both the mother and baby. This innovative strategy addresses not only the education aspect but also the economic barriers that might prevent expectant mothers from following a healthy diet.

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

Research has shown that providing healthy food during pregnancy can help manage weight gain. In this trial, participants in the Food Provision arm will receive targeted food support, including $1000 to purchase healthy foods, along with standard nutritional and gestational weight gain counseling. Studies indicate that women who receive nutrition education and guidance tend to experience healthier weight gain and better birth outcomes. Specifically, one study found that these interventions slightly increased pregnancy weight but improved overall birthweights. Additionally, focusing on a balanced diet with the right mix of proteins, fats, and carbs has been linked to lower weight gain during pregnancy. Overall, this evidence suggests that targeted food support might help reduce excessive weight gain in pregnant women. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 16-44 who are enrolled in CenteringPregnancy and speak English, Spanish, or Marshallese. It's not specified who can't join because the exclusion criteria are missing.

Inclusion Criteria

Resides in and plans to give birth in the state of Arkansas

I am 22 weeks pregnant or less.

I have a valid email address.

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, with the Food Provision arm receiving additional funds for healthy food purchases

Approximately 36 weeks

Baseline, midpoint (24-36 weeks gestation), and post-intervention visits

Follow-up

Participants are monitored for excessive gestational weight gain through birth records and post-partum surveys

8 weeks post-partum

What Are the Treatments Tested in This Trial?

Interventions

• Food Provision

Trial Overview The study compares two approaches: one group receives standard pregnancy care plus $500 for baby items post-delivery; the other gets the same care plus $1000 during pregnancy to buy healthy foods as advised by their nutritional counseling.

How Is the Trial Designed?

Group I: Food Provision Experimental Treatment 1 Intervention

The Food Provision arm includes the same nutritional and gestational weight gain counseling provided as standard of care. In addition, participants in the Food Provision arm will be provided with a total of $1000 during their pregnancy to be used specifically for the purchase of healthy foods.

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

The SoC arm includes implementing the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women. Additionally, participants in the SoC arm will receive $500 after delivery to be used for baby items.

Who Is Running the Clinical Trial?

University of Arkansas

Lead Sponsor

Trials

500

Recruited

153,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11895257/

Effectiveness of nutrition counseling in managing ... Nutrition education and counseling significantly increased gestational weight gain by 0.45 kg, improved birthweight, and reduced the risk of ...

2. nature.com nature.com/articles/s41598-025-07979-3

Effectiveness of nutrition literacy intervention on pregnancy ... The comprehensive nutritional literacy intervention implemented in early pregnancy significantly improved pregnant women's nutritional literacy levels.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0022316625006303

2020–2025 Dietary Guidelines for Americans in Pregnancy In the United States, nearly 50% of pregnant women exceed the recommended gestational weight gain (GWG), whereas only about 30% gain weight ...

4. bmcpregnancychildbirth.biomedcentral.com bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-025-07185-z

Effective dietary interventions during pregnancy: a systematic ... The primary aims of this systematic review and meta-analysis were to summarise the effectiveness of dietary interventions for pregnant woman.

5. mdpi.com mdpi.com/2072-6643/17/1/43

Nutritional Strategies Prescribed During Pregnancy and ... The gestational weight gain was 4.91–13.8 kg, and a lower weight gain was found in all studies that used the “macronutrient-adjusted diet” nutritional strategy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7725228/

Food insecurity during pregnancy and gestational weight ... Our results showed that inadequate food security was associated with lower total gestational weight gain, but that there were no statistically significant ...

7. ajcn.nutrition.org ajcn.nutrition.org/article/S0002-9165(24)00583-5/fulltext

Gestational weight gain below recommendations and adverse ... Pregnancy weight gain z-scores below, within, and above the IOM-recommended ranges occurred in 5%, 13%, and 80% of pregnancies with overweight ...

8. karger.com karger.com/anm/article/81/Suppl.%203/19/918603/Nutrition-during-Pregnancy-and-Birth-Outcomes

Nutrition during Pregnancy and Birth Outcomes A balanced, diverse, and nutritious diet that meets (without exceeding) the higher energy needs for gestational weight gain and higher nutrient ...

9. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2732571

Association of Gestational Weight Gain With Adverse ... Among women categorized as overweight, the absolute risk for any adverse outcome increased from 37.3% (249 of 667) for gestational weight gain ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S247529912502918X

Prenatal WIC Participation Is Associated with Gestational ... A 2022 systematic review on the maternal, infant and child health outcomes associated with WIC participation included 20 studies.