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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States1 site, 1 recruiting
- Recruiting
The University of Michigan
Ann Arbor, Michigan, 48109
Marika Waselewski, 734-237-3233, marikag@med.umich.edu
Tammy Chang, MD, MPH, MS
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).
- Conditions
- Pregnancy, Weight Gain
- 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 group | Role | What they receive |
|---|---|---|
| Women, Infants, and Children (WIC) | No intervention | Usual WIC counseling and food benefits for use in person at approved grocery stores. |
| WIC + grocery delivery | Experimental | Usual 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 delivery | Experimental | 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. 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.
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
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)
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
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
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
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.
- First posted11 Aug 2021
- Study start8 Dec 2021
- Primary completion1 Mar 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tammy Chang, University of Michigan
- Investigators
- Tammy Chang, MD, MPH, MS, Principal investigator, University of Michigan
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
- ClinicalTrials.gov ID
- NCT05000645
- Acronym / sponsor ID
- HUM00190614
- Conditions
- Pregnancy, Weight Gain
- Keywords
- WIC, Low-income, Diet, Sugar sweetened beverages, Grocery delivery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 570 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 11 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Women, Infants, and Children (WIC) | No intervention | –Usual WIC counseling and food benefits for use in person at approved grocery stores. |
| WIC + grocery delivery | Experimental | Behavioral: Grocery deliveryUsual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods. |
| WIC + grocery delivery + unsweetened beverage delivery | Experimental | Behavioral: Grocery delivery, Behavioral: Unsweetened beverage deliveryUsual 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. |
Who may qualify
- Ages
- 14 to 26 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Gestational age ≤ 20 weeks
- Text message capability
- Healthy singleton pregnancy
- Nulliparous
- Consume sugar sweetened beverages (SSBs)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grocery deliveryEach 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. | Behavioural | WIC + grocery delivery, WIC + grocery delivery + unsweetened beverage delivery |
| Unsweetened beverage deliveryParticipants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake. | Behavioural | WIC + grocery delivery + unsweetened beverage delivery |
Primary outcome
Weekly weight gain in pregnancy
Time frame: Up to delivery, approximately 40 weeks
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.
Total weight gain in pregnancy
Time frame: At delivery, approximately 40 weeks
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.
4 secondary outcomes
Dietary Quality as measured by the Healthy Eating Index (HEI) Score
Time frame: Up to delivery, approximately 40 weeks
Occurrence of prenatal complications
Time frame: Delivery, approximately 40 weeks
Occurrence of delivery complications
Time frame: Delivery, approximately 40 weeks
Baby birth weight
Time frame: Delivery, approximately 40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 35930351Waselewski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tammy Chang, MD, MPH, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
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.