Recruiting

Observational Study

Sponsor:

University of Michigan

Code:

NCT05000645

Conditions

Pregnancy

Weight Gain

Eligibility Criteria

Sex: Female

Age: 14 - 26

Healthy Volunteers: Not accepted

Interventions

Grocery delivery

Unsweetened beverage delivery

Study Details

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.

Conditions

Pregnancy

Weight Gain

Study ID

NCT05000645

Start date

Dec 8, 2021

Status verified date

Feb, 2026

Completion date

Apr 30, 2027

Anticipated

Primary completion date

Mar 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 14 - 26

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Study Design

Enrollment

570 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Women, Infants, and Children (WIC)

Usual WIC counseling and food benefits for use in person at approved grocery stores.

experimental: WIC + grocery delivery

Usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.

experimental: WIC + grocery delivery + unsweetened beverage 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.

Interventions

Grocery 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.

Unsweetened beverage delivery

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

Primary outcome measure

  • Weekly weight gain in pregnancy [ Time Frame: Up to delivery, approximately 40 weeks ]
  • Total weight gain in pregnancy [ Time Frame: At delivery, approximately 40 weeks ]

Central Contacts and Locations

Central contacts

Marika Waselewski

734-237-3233marikag@umich.edu

Locations

The University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Marika Waselewski

734-237-3233marikag@med.umich.edu

Principal Investigator:

Tammy Chang, MD, MPH, MS

More Information

Sponsor

University of Michigan

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • WIC
  • Low-income
  • Diet
  • Sugar sweetened beverages
  • Grocery delivery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-02-17.