An interventional study of Grocery delivery and Unsweetened beverage delivery in Pregnancy and Weight Gain, sponsored by University of Michigan. Recruiting at 1 site in United States. Open to female participants aged 14 Years to 26 Years. Per ClinicalTrials.gov, last updated 2026-02-17.
Sponsored by University of Michigan · Not applicable, Interventional, and Prevention
This project will increase knowledge about how a simple intervention, grocery delivery, impacts weight gain and diet among low-income pregnant young women. Results can then be used to support other pregnant young women.
The overall aim of this study is to determine whether an intervention that facilitates receipt of healthy food and unsweetened beverages will promote healthy weight gain and improve diet quality among pregnant young women age 14-26 living in Michigan. This hypothesis will be tested in a three-arm randomized controlled trial (RCT) using a parallel design; Arm 1: Usual WIC (Control), Arm 2: Usual WIC + Delivery of WIC-approved food, Arm 3: Usual WIC + Delivery of WIC-approved food PLUS unsweetened beverages. Three arms are necessary because our goal is to make three distinct comparisons. First, we need to determine the effect of food delivery (Arm 2) compared to usual WIC (Arm 1). Second, we need to determine the combined effect of food plus unsweetened beverage delivery (Arm 3) compared to usual WIC (Arm 1). Finally, we need to evaluate the effect of food delivery (Arm 2) compared with food plus unsweetened beverage delivery (Arm 3) to determine the individual impact of replacing SSBs, a major contributor to excessive pregnancy weight gain in our population. Our study does not assess the impact of delivering only unsweetened beverages compared to usual WIC because the potential policy implication is the delivery of WIC benefits. A widespread program that only delivers unsweetened beverages is not likely.
Upon completion of baseline screening and assessments, 570 pregnant young women will be randomly assigned to either the control group or one of the two experimental groups. Enrollment in the study is rolling and starts as early as possible in the pregnancy (must be before 21 weeks gestation). The intervention period begins at enrollment and continues to the end of pregnancy/birth. Thus, each participant will be enrolled for approximately seven months post-randomization. During the intervention period, all groups will receive usual WIC food, nutritional assessment, and counseling benefits, including monthly intensive nutritional counseling sessions based on a state-approved curriculum with trained nutritionists and peer counselors.
The primary outcome is weight gain during pregnancy as defined by the Institute of Medicine (IOM)/National Academy of Medicine (NAM) Guidelines. Secondary outcomes include Healthy Eating Index (HEI) scores and dietary intake of fruits, vegetables, whole grains, and SSBs; infant birth weight; and prenatal and delivery complications identified through postpartum medical record review (e.g., small/large for gestational age, gestational diabetes, hypertensive disorders, operative delivery).
317 studies on the registry are indexed under Weight Gain; 48 are open to participants now.
This study's planned enrollment of 570 is above the median of 83 across 251 interventional studies indexed under Weight Gain.
Browse Weight Gain studies →University of Michigan is the lead sponsor of 1,506 studies on the registry; 192 are open to participants now.
Of its 169 completed or terminated interventional studies of FDA-regulated products, 133 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Usual WIC counseling and food benefits for use in person at approved grocery stores.
Usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.
Behavioral: Grocery delivery
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.
Behavioral: Grocery delivery · Behavioral: Unsweetened beverage delivery
Each food delivery will contain approximately $35 worth of fresh fruits, vegetables, dairy products, and whole grain foods. These foods are not meant to supplant regular meals, rather make healthy eating more convenient.
Participants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake.
Weekly weight gain in pregnancy
Frequency of weight categorizations, categorized as above, below, or within Institute of Medicine/National Academy of Medicine (IOM/NAM) guidelines, will be assessed. Data collected from BodyTrace scale and calculated as weight for a particular week minus pre-pregnancy weight.
Time frame: Up to delivery, approximately 40 weeks
Total weight gain in pregnancy
Frequency of weight categorizations, categorized as above, below, or within Institute of Medicine/National Academy of Medicine (IOM/NAM) guidelines will be assessed. Data collected from BodyTrace scale and calculated as end of pregnancy weight minus pre-pregnancy weight.
Time frame: At delivery, approximately 40 weeks
Dietary Quality as measured by the Healthy Eating Index (HEI) Score
Dietary recall data collected via the ASA24 (Automated Self-Administered 24-Hour) Dietary Recall Survey will be used to determine continuous HEI scores. ASA24 data are collected twice at enrollment, twice in second trimester, and twice in third trimester and used in pairs to calculate 3 HEI scores per participant. The HEI uses a scoring system to evaluate a set of foods. The scores range from 0 to 100 with higher scores correlating to higher diet quality.
Time frame: Up to delivery, approximately 40 weeks
Occurrence of prenatal complications
Frequency of prenatal complications will be assessed. Complications are collected from mother's medical record examples include gestational diabetes and hypertensive disorders.
Time frame: Delivery, approximately 40 weeks
Occurrence of delivery complications
Frequency of delivery complications will be assessed. Complications are collected from mother's medical record and include operative delivery, shoulder dystocia, and postpartum hemorrhage.
Time frame: Delivery, approximately 40 weeks
Baby birth weight
Collected from mother's medical record and will be categorized as small, appropriate, or large for gestational age based on weight percentiles (small \< 10th percentile, appropriate ≥ 10th percentile and ≤ 90th percentile, large \> 90th percentile).
Time frame: Delivery, approximately 40 weeks
Plan to share: No
Started Dec 2021 (actual). Primary completion is estimated for Mar 2027, 62 months after the start.
Of 95 non-industry interventional studies with no phase under Weight Gain, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 62 months is above that.
Counting every sponsor, half of 101 studies reached it within 27 months; a quarter within 12 and three quarters within 47.
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