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PregnancyNCT05000645

Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women

A study testing Grocery delivery and Unsweetened beverage delivery in people with Pregnancy and Weight Gain, run by University of Michigan at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 14 to 26 years, women only
Conditions the study is for
Pregnancy, Weight Gain
What is being tested?
Grocery delivery and Unsweetened beverage delivery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
570 participants
Where
1 siteUnited States
Study dates
8 Dec 2021to 30 Apr 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 26 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Gestational age ≤ 20 weeks
  • Text message capability
  • Healthy singleton pregnancy
  • Nulliparous
  • Consume sugar sweetened beverages (SSBs)
  • Living within delivery zone of a grocery delivery service

Who cannot join

  • Non-English speaking
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marika Waselewski contact

734-237-3233

marikag@umich.edu

United States1 site, 1 recruiting
  • The University of Michigan

    Ann Arbor, Michigan, 48109

    Marika Waselewski, 734-237-3233, marikag@med.umich.edu

    Tammy Chang, MD, MPH, MS

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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 control group (Arm 1) will receive usual WIC counseling and food benefits loaded onto their electronic benefits card (EBT) for them to use in person at approved grocery stores.
  • The first experimental group (Arm 2) will receive usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.
  • The second experimental group (Arm 3) will receive usual WIC counseling and food benefits as well as twice-monthly home deliveries of WIC-approved foods PLUS unsweetened beverages to replace their current SSB intake.

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).

Being tested
Grocery delivery, Unsweetened beverage delivery
Keywords
WIC, Low-income, Diet, Sugar sweetened beverages, Grocery delivery
Medical subject headings
Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Grocery deliveryBehavioural

    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.

  • Unsweetened beverage deliveryBehavioural

    Participants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake.

Study groups in NCT05000645
Study groupRoleWhat they receive
Women, Infants, and Children (WIC)No interventionUsual WIC counseling and food benefits for use in person at approved grocery stores.
WIC + grocery deliveryExperimentalUsual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.
Receives: Behavioral: Grocery delivery
WIC + grocery delivery + unsweetened beverage deliveryExperimentalUsual 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.
Receives: Behavioral: Grocery delivery; Behavioral: Unsweetened beverage delivery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to delivery, approximately 40 weeks

  2. 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.

    Measured: At delivery, approximately 40 weeks

Secondary outcomes (4)
  1. 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.

    Measured: Up to delivery, approximately 40 weeks

  2. 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.

    Measured: Delivery, approximately 40 weeks

  3. 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.

    Measured: Delivery, approximately 40 weeks

  4. 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).

    Measured: Delivery, approximately 40 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2021
  2. Study start8 Dec 2021
  3. Primary completion1 Mar 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
570 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05000645
Sponsor's protocol ID
HUM00190614
Other IDs
1R01HD101522
Status last verified
Feb 2026
First submitted
3 Aug 2021
Last updated
17 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Waselewski M, Plegue M, Sonneville K, Resnicow K, Ghumman A, Ebbeling C, Mahmoudi E, Sen A, Wolfson JA, Chang T. Grocery Delivery to Support Healthy Weight Gain Among Pregnant Young Women With Low Income: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 5;11(8):e40568. doi: 10.2196/40568.

    PubMed 35930351

Questions about this trial

What is this clinical trial studying?

A study testing Grocery delivery and Unsweetened beverage delivery in people with Pregnancy and Weight Gain, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marika Waselewski (734-237-3233, marikag@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weekly weight gain in pregnancy (time frame: Up to delivery, approximately 40 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05000645, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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