Grocery Delivery to Support Healthy Weight Gain Among Pregnant Young Women With Low Income: Protocol for a Randomized Controlled Trial

Background Excessive weight gain during pregnancy is associated with complications for both the mother and her infant including gestational diabetes, hypertensive disorders, operative delivery, and long-term obesity. A healthy diet during pregnancy promotes healthy gestational weight gain and determines fetal epigenetic programming in infants that impacts risk for future chronic disease. Objective This project will examine the impact of grocery delivery during pregnancy on the weight, diet, and health outcomes of young pregnant women and their infants. Methods A three-arm randomized controlled trial design will be performed. A total of 855 young pregnant women, aged 14-24 years, from across the state of Michigan will be enrolled and randomized equally into the three study arms. Participants in arm one (control) will receive usual care from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); arm two will receive WIC plus biweekly grocery delivery; and arm three will receive WIC plus biweekly grocery and unsweetened beverage delivery. Weight will be assessed weekly during pregnancy, and total pregnancy weight gain will be categorized as above, below, or within guidelines. Additionally, dietary intake will be assessed at three time points (baseline, second trimester, and third trimester), and pregnancy outcomes will be extracted from medical records. The appropriateness of pregnancy weight gain, diet quality, and occurrence of poor outcomes will be compared between groups using standard practices for multinomial regression and confounder adjustment. Results This study was funded in April 2021, data collection started in December 2021, and data collection is expected to be concluded in 2026. Conclusions This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low income. The findings will inform policies and practices that promote a healthy diet during pregnancy, which has multigenerational impacts on health. Trial Registration ClinicalTrials.gov NCT05000645; https://clinicaltrials.gov/ct2/show/NCT05000645 International Registered Report Identifier (IRRID) DERR1-10.2196/40568


DESCRIPTION (provided by applicant):
Excess weight gain during pregnancy among low income pregnant youth is associated with serious multi-generational morbidity for both the mother and infant. Healthy diet and limiting sugar sweetened beverages during pregnancy promotes healthy weight gain during pregnancy and impacts permanent fetal genetic programming that determines risk for chronic disease among infants. Making healthy diet choices convenient improves quality of diet among youth. The Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits cover the cost of healthy foods for low income pregnant women, but most young mothers are not able to obtain the food due to logistical barriers such as transportation. Grocery delivery is a well-established and inexpensive service that removes logistical barriers to obtaining healthy food but is underused by those that may need it most -young pregnant women. The objective of this application is to determine the impact of delivering healthy foods during pregnancy on the health of low-income young women and their infants. For this three-armed randomized control trial, subjects are pregnant young women ≤24 years of age who are giving birth for the first time and enrolled in WIC (Arm 1: Usual WIC (Control), Arm 2: Delivery of WIC-approved food only, Arm 3: Delivery of WIC-approved food PLUS unsweetened beverages). Subjects are randomly assigned to experimental or control groups. Weight and dietary data will be recorded throughout their pregnancy for all groups. In both experimental groups (Arm 2 & 3), the intervention will last from the first trimester of their pregnancy to the birth of their infant. Arm 2 will receive healthy food delivery every two weeks. Arm 3 will receive healthy food and unsweetened beverage delivery every two weeks. This project will advance the scientific knowledge about the effect of a simple and inexpensive intervention (grocery delivery) on weight gain and dietary behaviors among low-income pregnant young women, which can be applied to policies and practices that affect other vulnerable populations.

PUBLIC HEALTH RELEVANCE:
Excessive weight gain during pregnancy among pregnant young women is associated with serious multi-generational morbidity for both the mother and infant. This project will advance the scientific knowledge about the effect of grocery delivery on weight gain and diet during pregnancy among low-income pregnant young women who have limited access to healthy foods. Overall Impact: This is a resubmission application from an accomplished junior investigator that will examine the effect of grocery delivery during pregnancy on diet and weight gain in low-income pregnant young women with overweight or obesity. It is a 3 arm study: usual WIC care (Arm 1), home delivery of WIC-approved foods only (Arm 2), or Arm 2 combined with unsweetened beverages (Arm 3). Primary outcome is gestational weight gain (total gestational weight gain and weekly weight gain assessed using bodytrace 3G scales); secondary outcomes include quality of diet (assessed using the ASA24, calculating the healthy eating index score), pregnancy outcomes (complications, birth weight), process outcomes (experience with food deliveries, adequate delivery of items), and cost. The proposal addresses an important public health issue as excessive weight gain during pregnancy is an important determinant of pregnancy and infant outcomes in the targeted population. The multidisciplinary team is strong with requisite expertise to successfully accomplish the stated aims. The potential scalability of the intervention is a notable strength. The team responded to several of the concerns noted by reviewers in the first submission; improved their assessment of diet, discussed that WIC will be providing instructions and training on food preparation (albeit without additional training from the research team), improved their assessment of the home food environment (to better assess this as a potential confounder), and discussed their focus on youth ages 14-24 years (as these are most at-risk for logistical barriers for obtaining healthy foods due to limited transportation). Despite these modifications, the team did not address some of the critical limitations noted in the first application, particularly with regard to 1) solely addressing issues of access to drive gestational weight gain, when healthy eating and weight gain is due to a multitude of factors as described in the 2009 IOM conceptional model of determinants/guidelines (and data from the PIs own qualitative study revealed that convenience was only one factor influencing mother's gestational weight gain; however, stress was another significant factor but not being addressed in this proposal); 2) evidence that having WIC available foods is associated with excessive gestational weight gain (while WIC may improve mothers' nutrition, limited to no data indicate the WIC food package decreases the consumption of unhealthy foods bought by other members in the home or from the corner store, or affects stress and motivation, factors that may be important for young moms who live in multigenerational households and don't have control over the food environment). Overall, however, impact is thought to be high.

Strengths
• Excess gestational weight gain is an important determinant of pregnancy and postpartum outcomes for mom and baby.
• Sugar sweetened beverages are a large source of calories and contribute to excessive gestational weight gain; interventions to address SSBs may reduce gestational weight gain.
• Few interventions are focused on adolescents and young adults.
• Grocery delivery may reduce barriers to healthy food access.

Weaknesses
• Access is clearly not the only variable impacting nutrition and healthy weight among teens and young adults. • No mention of the fact that the WIC food package encourages the consumption of juice and includes this as part of their benefit package (and how this may influence weight).

Strengths
• Key personnel represent a range of experience related to the project including family medicine (Chang), nutritional and behavioral intervention research (Resnicow, Sonneville), cost effectiveness (Mahmoudi), health policy (Wolfson), and biostatistics (Sen).

Weaknesses
• Having an investigator/key personnel from WIC would be helpful to ensure adequate buy-in by WIC staff and potential for integration/dissemination/scalability.

Strengths
• Inclusion of an overlooked group -adolescents and young adults in gestational weight gain studies.

Weaknesses
• Use of bodytrace scales and text messaging is not particularly innovative.

Strengths
• Application builds on successful studies by Ebbeling (Consultant) and Resnicow (Co-Investigator), delivering unsweetened beverages to overweight and obese youth, along with leveraging the successful texting platform of PI.
• PI conducted a pilot study on feasibility of recruitment and acceptability of WIC grocery delivery -both were positive. Also showed in a non-randomized, small sample that there is potential to decrease rates of excessive gestational weight gain with this same approach.
• Use of ASA-24 for assessing dietary quality is much improved over a 4 item FFQ.

Weaknesses
• The team reports that WIC providers do intensive nutritional counseling -including MIhowever, more evidence is needed from Michigan WIC staff to believe that busy, underresourced WIC providers are able to do more than just adequate/cursory counseling, and counsel more than every 3 months.
• Use of self-reported pre-pregnancy weights in this population may be biased, given most of these individuals probably don't have scales in their homes to accurately know their prepregnancy weights.
• While using bodytrace scales eliminates issues around transportation for assessments, connectivity can still be an issue along with user error for these to measure the primary outcome.
• While the investigators are planning to have a better self-reported inventory of the home food environment (to evaluate this variable as a potential confounder/effect modifier), their 1 R01 HD101522-01A1 5 CLHP CHANG, T intervention still doesn't seem to address the issues of other foods/beverages in the home and kitchen supplies, additional determinants of healthy weight gain.
• The WIC food package currently allows for juice and milk; the investigators don't discuss how they will deal with this issue (while it's 100% fruit juice and low fat milk, it still has significant quantities of sugar and many define both as a sugar sweetened beverages with deleterious effects on health, e.g., REGARDS study).

Strengths
• The environment and resources at University of Michigan are excellent.

Strengths
• Sufficient timeline provided for recruitment and intervention delivery. While enrolling more than 20 women a month seems high for this new investigator, her feasibility studies and strong team lesson concerns.

Resubmission
• The team responded to several of the concerns noted by reviewers in the first submission; improved their assessment of diet, discussed that WIC will be providing instructions and training on food preparation (albeit without additional training from the research team), improved their assessment of the home food environment (to better assess this as a potential confounder), and discussed their focus on youth ages 14-24 years (as these are most at-risk for logistical barriers for obtaining healthy foods due to limited transportation).

CRITIQUE 2
Significance: 2 Investigator(s): 2 Innovation: 2 Approach: 3 Environment: 2 Overall Impact: This resubmission is from a new investigator. The study aims to evaluate the impact of delivering healthy foods to WIC-enrolled pregnant women on pregnancy weight gain and dietary behaviors. It will use a RCT to compare outcomes among three groups: (1) Usual WIC (Control); (2) Delivery of WIC-approved food only; and (3) Delivery of WIC-approved food PLUS unsweetened beverages. A cost analysis from a payer's perspective will also be conducted to assist with decisionmaking. The study is based on prior evidence suggesting that SSB is a risk factor for overweight and is consumed by a high percentage of young pregnant women. Findings will have direct policy implications. The study is innovative focusing on a group that is often overlooked in research (pregnant young women) and using low-burden technology for the intervention and collection of data (weight). The approach is well thought out and designed with WIC collaborators and while not specifically discussed, uses basic principles of CBPR. The exclusion and inclusion criteria are appropriate; the timeline is realistic and data collection methods are feasible. The team also has prior experience working the WIC program. There are enthusiastic letters of support from WIC. Sample size is adequate. One minor concern is the potentially modifying effect of SNAP participation. WIC provides less $ for food assistance than SNAP and it is possible that SNAP participation may modify the effect. Another concern (previously noted by reviewers) is the potential for contamination.

Significance
Strengths 1 R01 HD101522-01A1 7 CLHP CHANG, T • Based on prior research showing that access to healthy foods and beverages is a barrier to healthy eating along low income pregnant women and that SSB is a risk factor for obesity and consumed by a high percentage of low income young adults.

Weaknesses
• Other risk factors were not discussed

Strengths
• PI is a new investigator trained in family medicine and public health with a productive record.
• Excellent team

Weaknesses
• None noted by reviewer

Strengths
• Focuses on a group that is often overlooked in research (pregnant young women) • Uses low-burden technology for the intervention and collection of data (weight)

Weaknesses
• None noted by reviewer

Strengths
• RCT that is feasible and well-planned.
• Intervention activities well thought out and described.
• Appropriate (and feasible) exclusion and inclusion criteria.
• Prior experience (in team) in recruitment and data collection methods.
• Process will be evaluated.
• Engagement of stakeholders including WIC collaborators in design of study (not innovative but important) and dissemination of findings.
• Prior experience working WIC.
• Sample size is adequate and analytic plan appropriate.
• Appropriate incentives for recruitment and retention of participants.

Weaknesses
• ASA24 can be tedious and it was not clear if this will be done in the WIC clinic or at home. If the latter, internet connection is required.
• SNAP participation may confound or modify effect and there was no indication that SNAP participation status would be included in the analysis (or data collection).
• Description of collection/acquisition of cost data was missing.
• There is still potential for contamination.

Resubmission
• Previous reviewers' concerns were adequately addressed to a large extent • There is still the potential for contamination but an attempt was made to address it.

Authentication of Key Biological and/or Chemical Resources
Not Applicable (No Relevant Resources) 1 R01 HD101522-01A1 9 CLHP CHANG, T

CRITIQUE 3
Significance: 1 Investigator(s): 1 Innovation: 1 Approach: 2 Environment: 1 Overall Impact: This R01 resubmission seeks to conduct a 3-arm RCT to determine the impact of using twice-monthly grocery delivery services to deliver healthy foods to pregnant young (24 y or younger) primiparous WIC recipients (Arm 1: Usual WIC (Control), Arm 2: Delivery of WIC-approved food only, Arm 3: Delivery of WIC-approved food PLUS unsweetened beverages).Their overall goal is to identify effective interventions to increase the consumption of healthy foods and decrease the consumption of sugar-sweetened beverages (SSB) during pregnancy to prevent excessive weight gain among low-income pregnant young women. The significance is high, the rigor of prior research is strong, and the investigative team is strong. Level of innovation is high. The approach is feasible, and using electronic scales to objectively report the primary outcome measure is both feasible and rigorous, with high levels of fidelity. The use of participant incentives is thoughtfully and creatively considered. This project has the potential for scalability and for high impact.

Strengths
• Excessive gestational weight gain is an important health issue, with huge implications for the mother and future generations. Excessive weight gain is common among teen and young mothers.
• For young women receiving WIC benefits, there are often logistical barriers to obtaining the food.
• Rigor of prior research, including that done by the PI and the research team, is strong.

Strengths
• Excellent expertise in behavioral interventions, social media and text messaging, family medicine, OB-Gyn, health behavior, nutritional sciences, health policy, health economics, mixed methods, and biostatistics.
• The team has a history of collaboration.

Strengths
• Grocery delivery of healthy foods is innovative.
• Text messaging to collect data is innovative.

Strengths
• The Community Advisory Board is an excellent resource.
• Use of electronic scales that automatically transmit results to researchers improves fidelity of the primary outcome measure of maternal weight gain during pregnancy.
• Conducting quantitative, qualitative, and cost analyses will provide a rich, comprehensive assessment of this project.
• There is likely to be low attrition rates, given that recipients receive free groceries or have the prospect of a free grocery delivery service after baby's birth.

Weaknesses
• Conducting end-of-study qualitative interviews with all of the 855 participants may be more than is needed to reach thematic saturation.

Strengths
• The University of Michigan has outstanding resources.
• There are appropriate letters of support from WIC centers.

Weaknesses
• None noted by reviewer

Acceptable Risks and/or Adequate Protections
• Pregnant women and minors are both vulnerable populations, and considerations regarding this status should be outlined.

Resubmission
• This resubmission was very responsive to reviewer comments.

THE FOLLOWING SECTIONS WERE PREPARED BY THE SCIENTIFIC REVIEW OFFICER TO SUMMARIZE THE OUTCOME OF DISCUSSIONS OF THE REVIEW COMMITTEE, OR REVIEWERS' WRITTEN CRITIQUES, ON THE FOLLOWING ISSUES:
1 R01 HD101522-01A1 12 CLHP CHANG, T Footnotes for 1 R01 HD101522-01A1; PI Name: Chang, Tammy NIH has modified its policy regarding the receipt of resubmissions (amended applications).See Guide Notice NOT-OD-18-197 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-18-197.html. The impact/priority score is calculated after discussion of an application by averaging the overall scores (1-9) given by all voting reviewers on the committee and multiplying by 10. The criterion scores are submitted prior to the meeting by the individual reviewers assigned to an application, and are not discussed specifically at the review meeting or calculated into the overall impact score. Some applications also receive a percentile ranking. For details on the review process, see http://grants.nih.gov/grants/peer_review_process.htm#scoring.

Community-Level Health Promotion Study Section
Healthcare Delivery and Methodologies Integrated Review Group CENTER FOR SCIENTIFIC REVIEW CLHP 06/15/2020 -06/16/2020 Notice of NIH Policy to All Applicants: Meeting rosters are provided for information purposes only. Applicant investigators and institutional officials must not communicate directly with study section members about an application before or after the review. Failure to observe this policy will create a serious breach of integrity in the peer review process, and may lead to actions outlined in NOT-OD-14-073 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-14-073.html and NOT-OD-15-106 at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-106.html, including removal of the application from immediate review.