NCT05000645

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
570

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
11mo left

Started Dec 2021

Longer than P75 for not_applicable pregnancy

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Dec 2021Apr 2027

First Submitted

Initial submission to the registry

August 3, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

December 8, 2021

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

5.2 years

First QC Date

August 3, 2021

Last Update Submit

February 11, 2026

Conditions

PregnancyWeight Gain

Keywords

WICLow-incomeDietSugar sweetened beveragesGrocery delivery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    At delivery, approximately 40 weeks

Secondary Outcomes (4)

  • Dietary Quality as measured by the Healthy Eating Index (HEI) Score

    Up to delivery, approximately 40 weeks

  • Occurrence of prenatal complications

    Delivery, approximately 40 weeks

  • Occurrence of delivery complications

    Delivery, approximately 40 weeks

  • Baby birth weight

    Delivery, approximately 40 weeks

Study Arms (3)

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.

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.

Behavioral: Grocery deliveryBehavioral: Unsweetened beverage delivery

Interventions

Grocery deliveryBEHAVIORAL

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.

WIC + grocery deliveryWIC + grocery delivery + unsweetened beverage delivery
Unsweetened beverage deliveryBEHAVIORAL

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

WIC + grocery delivery + unsweetened beverage delivery

Eligibility Criteria

Age14 Years - 26 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 35930351DERIVED

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Tammy Chang, MD, MPH, MS

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marika Waselewski

CONTACT

734-237-3233marikag@umich.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Family Medicine

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 11, 2021

Study Start

December 8, 2021

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)