Grocery Delivery for Healthy Pregnancy Weight Management

Overseen By Tammy Chang, MD, MPH, MS

Age: < 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Non-English, High risk pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

570 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how grocery delivery can help manage healthy weight gain and improve diet in low-income pregnant young women. The trial tests three groups: one with regular support, another with added grocery delivery, and a third with grocery and unsweetened beverage delivery to replace sugary drinks. It seeks pregnant women who are 20 weeks or less into their pregnancy, have a single baby on the way, can receive text messages, and live in an area where groceries can be delivered. Participants should also currently drink sugar-sweetened beverages.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance dietary support for pregnant 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?

Earlier studies found that delivering healthy groceries to low-income pregnant women was practical and well-received, indicating it is safe and accepted. Research on grocery delivery did not reveal any serious problems, suggesting it is likely safe for pregnant women.

For delivering unsweetened drinks, specific safety information is limited. However, switching from sugary drinks to unsweetened ones is generally considered a healthy choice and can help maintain a healthy weight during pregnancy. The studies reviewed did not link any major negative effects to drinking unsweetened beverages.

Overall, both grocery delivery and unsweetened beverage delivery appear safe based on the available research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to support healthy pregnancy weight management through convenient and accessible methods. Unlike traditional approaches that rely solely on in-person WIC counseling and food benefits, this study tests the effectiveness of adding grocery and unsweetened beverage deliveries directly to participants' homes. This new delivery method aims to make it easier for pregnant women to access nutritious foods and reduce sugar intake without extra trips to the store, potentially leading to better health outcomes for both mothers and babies. By investigating these novel approaches, researchers hope to uncover practical solutions that can be easily integrated into existing nutritional support programs.

What evidence suggests that this trial's treatments could be effective for healthy pregnancy weight management?

Research has shown that delivering healthy groceries can improve diet and help manage weight for low-income pregnant women. In this trial, one group will receive usual WIC counseling and food benefits along with grocery delivery. Another group will receive grocery delivery plus unsweetened beverages to replace sugar-sweetened ones. A study found that supermarket programs, like grocery delivery, can lead to healthier eating, which is linked to better pregnancy outcomes. Additionally, replacing sugary drinks with unsweetened options can aid in weight management and overall health. These strategies aim to support healthy weight gain during pregnancy, benefiting both mother and baby. ^{1 3 4 6 7}

Who Is on the Research Team?

Tammy Chang, MD, MPH, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for low-income, pregnant young women who are less than 20 weeks along, have a healthy single pregnancy, can text message, haven't had children before (nulliparous), drink sugary beverages and live where grocery delivery services operate. It's not for those with high-risk pregnancies needing special care like pre-existing diabetes, non-English speakers or if they share an address with another participant.

Inclusion Criteria

Nulliparous

Consume sugar sweetened beverages (SSBs)

Text message capability

Exclusion Criteria

Participants who live at the same address

Physical, mental, or cognitive handicaps that prevent participation

High risk pregnancy requiring specialized care (including pre-existing diabetes)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive usual WIC counseling and food benefits, with some receiving additional home deliveries of WIC-approved foods and unsweetened beverages

Approximately 7 months

Monthly intensive nutritional counseling sessions

Follow-up

Participants are monitored for weight gain, dietary quality, and delivery outcomes

Up to delivery, approximately 40 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Grocery delivery
• Unsweetened beverage delivery

Trial Overview The study is testing whether delivering groceries and unsweetened beverages to participants' homes affects their weight gain and diet during pregnancy. The goal is to see if this simple support helps maintain a healthy weight among these young women.

How Is the Trial Designed?

Group I: WIC + grocery delivery + unsweetened beverage delivery Experimental Treatment 2 Interventions

Usual WIC counseling and food benefits as well as twice-monthly home deliveries of WIC-approved foods PLUS unsweetened beverages to replace their current sugar-sweetened beverages (SSB) intake.

Group II: WIC + grocery delivery Experimental Treatment 1 Intervention

Usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.

Group III: Women, Infants, and Children (WIC) Active Control 1 Intervention

Usual WIC counseling and food benefits for use in person at approved grocery stores.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

This study aims to evaluate the effectiveness of a nutritional intervention promoting unprocessed and minimally processed foods, along with physical activity, for managing weight gain in overweight pregnant women, involving 300 participants over 12 months.

It will be the first randomized controlled trial to assess how this intervention impacts pregnancy outcomes, neonatal body composition, and the growth of children at 6, 12, and 24 months, potentially providing valuable insights into maternal and child health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study Protocol effectiveness of a nutritional intervention based on encouraging the consumption of unprocessed and minimally processed foods and the practice of physical activities for appropriate weight gain in overweight, adult, pregnant women: a randomized controlled trial. Sartorelli, DS., Crivellenti, LC., Manochio-Pina, MG., et al.[2020]

Nutritional scoring and messaging are the most effective strategies for promoting healthier food purchases in U.S. grocery stores, particularly in SNAP-authorized settings, based on a review of 73 studies.

Simple intervention strategies tend to be more successful and less burdensome for shoppers, suggesting they should be prioritized for policy implementation in grocery retail environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Encouraging Healthier Food and Beverage Purchasing and Consumption: A Review of Interventions within Grocery Retail Settings. Wolgast, H., Halverson, MM., Kennedy, N., et al.[2022]

A randomized controlled trial involving 350 overweight pregnant women showed that nutritional counseling focused on unprocessed foods and physical activity significantly reduced the likelihood of excessive gestational weight gain, with an odds ratio of 0.56.

The study highlights the effectiveness of using the NOVA food classification system in dietary interventions, marking a novel approach to managing weight gain during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a minimally processed food-based nutritional counselling intervention on weight gain in overweight pregnant women: a randomized controlled trial. Sartorelli, DS., Crivellenti, LC., Baroni, NF., et al.[2023]

A systematic review of 17 studies found that tailored nutrition tools for pregnant women are more effective, especially when delivered by dietitians or nutritionists, highlighting the importance of personalized support in promoting healthy dietary intake.

The feasibility of these nutrition tools depends on practical factors like time investment and the motivation and skills of healthcare providers, indicating that effective implementation requires well-trained professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Interventions for Healthy Pregnant Women: A Systematic Review of Tools to Promote a Healthy Antenatal Dietary Intake. Beulen, YH., Super, S., de Vries, JHM., et al.[2021]

A randomized trial involving 264 women with overweight or obesity found that a prenatal behavioral intervention using meal replacements did not significantly help women return to their prepregnancy weight or reduce postpartum weight retention after 12 months.

Despite the intervention reducing excess gestational weight gain, it did not lead to lasting changes in weight control behaviors after delivery, indicating that simply reducing weight gain during pregnancy may not be enough to prevent postpartum weight retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Partial Meal Replacement During Pregnancy Reduce 12-Month Postpartum Weight Retention? Phelan, S., Wing, RR., Brannen, A., et al.[2021]

A study involving 247 participants showed that supermarket-based dietary interventions, particularly those led by dietitians and enhanced with online tools, significantly improved adherence to the DASH diet over 3 months, with a notable increase in DASH scores compared to a control group.

The more comprehensive Strategy 2, which included online shopping tools and meal planning, resulted in a greater improvement in dietary quality than the simpler Strategy 1, highlighting the effectiveness of integrating technology into dietary education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of supermarket and web-based interventions for improving dietary quality: a randomized, controlled trial. Steen, DL., Helsley, RN., Bhatt, DL., et al.[2023]

A study involving 64 pregnant women showed that 86% were interested in using a website or mobile app to manage healthy weight gain during pregnancy, indicating a strong demand for digital health tools in this area.

The findings suggest that online interventions could effectively help prevent excessive weight gain during pregnancy, which is important for the health of both mothers and their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pregnant women's interest in a website or mobile application for healthy gestational weight gain. Waring, ME., Moore Simas, TA., Xiao, RS., et al.[2018]

The study analyzed data from 55,608 birth records in Allegheny County, PA, revealing that women living in neighborhoods with higher socioeconomic disadvantage (NSED) were more likely to experience inadequate gestational weight gain or weight loss during pregnancy, particularly among Black women.

Specifically, Black women in high NSED areas had a 60% higher risk of weight loss during pregnancy compared to those in low NSED areas, highlighting the impact of neighborhood socioeconomic factors on pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neighborhood socioeconomic disadvantage and gestational weight gain and loss. Mendez, DD., Doebler, DA., Kim, KH., et al.[2022]

A systematic review of 40 studies found that the quality of food environments in hospitals varies significantly, impacting the availability of healthy food and beverages for employees and visitors.

Interventions like education, labeling, and financial incentives can enhance the hospital food environment, but multi-component strategies may inadvertently reduce the intake of fruits and vegetables.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Availability of Healthy Food and Beverages in Hospital Outlets and Interventions in the UK and USA to Improve the Hospital Food Environment: A Systematic Narrative Literature Review. Richardson, S., McSweeney, L., Spence, S.[2022]

In a study of 163 overweight women, those who received structured meal plans and grocery lists lost significantly more weight than those who only participated in a standard behavioral treatment program, with weight loss averages of -12.0 kg compared to -8.0 kg after six months.

The study found that providing free food did not lead to additional weight loss benefits, indicating that the key factor for success was the structured meal planning rather than the actual provision of food.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Food provision vs structured meal plans in the behavioral treatment of obesity. Wing, RR., Jeffery, RW., Burton, LR., et al.[2014]

The 'Rolling Store' intervention, combined with nutrition education, led to a significant weight loss of 2.0 kg among African American women, while the control group gained weight, highlighting its efficacy in promoting healthy eating and weight management.

Participants in the intervention group also increased their daily servings of fruits and vegetables, demonstrating that the program not only aids in weight loss but also encourages healthier dietary habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The "Rolling Store:" an economical and environmental approach to the prevention of weight gain in African American women. Kennedy, BM., Champagne, CM., Ryan, DH., et al.[2022]

A study involving 353 pregnant women in Brazil showed that an educational intervention focused on healthy eating reduced the percentage of energy intake from ultra-processed foods by 4.6% between the first and second trimesters.

Training healthcare professionals to promote healthy food practices during prenatal care is an effective strategy to encourage better nutrition among pregnant women, although the impact did not persist into the third trimester.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-processed Food Consumption by Pregnant Women: The Effect of an Educational Intervention with Health Professionals. Gomes, CB., Malta, MB., Louzada, MLDC., et al.[2020]

A study involving 50 participants with food insecurity showed that using a prefilled, nutritionally balanced online grocery shopping cart led to significantly healthier purchases compared to just reviewing nutrition information.

Participants using the default shopping cart bought more whole grains, fruits, and vegetables, while also selecting foods lower in sodium, cholesterol, and unhealthy fats, indicating that this approach can effectively promote better nutrition in financially constrained individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nudging while online grocery shopping: A randomized feasibility trial to enhance nutrition in individuals with food insecurity. Coffino, JA., Udo, T., Hormes, JM.[2021]

A pilot study with 28 overweight participants showed that using a grocery home delivery service alongside standard behavioral weight loss treatment significantly reduced the number of foods in the home, particularly high-fat items.

While both treatment groups lost similar amounts of weight over 8 weeks, there was a trend suggesting that more frequent home deliveries correlated with weight loss, indicating potential benefits of this approach for healthier eating habits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home grocery delivery improves the household food environments of behavioral weight loss participants: results of an 8-week pilot study. Gorin, AA., Raynor, HA., Niemeier, HM., et al.[2021]

Citations

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Grocery Delivery of Healthy Foods to Pregnant Young Women ... A grocery delivery–based weight gain and nutrition intervention is both feasible and acceptable among low-income pregnant youth.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9391971/

Grocery Delivery to Support Healthy Weight Gain Among ... This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low income.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05000645?tab=table

Grocery Delivery and Healthy Weight Gain Among Low ... The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure.

4. researchgate.net researchgate.net/publication/361958398_Grocery_delivery_to_support_healthy_weight_gain_among_pregnant_young_women_with_low-income_protocol_for_a_randomized_controlled_trial_Preprint

(PDF) Grocery delivery to support healthy weight gain ... Conclusions: This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low ...

5. nature.com nature.com/articles/s41591-022-02077-7

Efficacy of supermarket and web-based interventions for ... This trial demonstrates the efficacy of data-guided, supermarket-based, dietary interventions and modern online shopping tools in improving dietary quality.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35930351/

Grocery Delivery to Support Healthy Weight Gain Among ... This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low income.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1551714423002331

Study design and protocol for Nourishing Beginnings, an ... Nourishing Beginnings is an integrated referral and service delivery model supporting Medicaid-eligible pregnant individuals by providing increased nutritional ...