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

NCT ID: NCT05000645

Last Updated: 2025-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 570 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-08
• Study Completion Date: 2027-10-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Women, Infants, and Children (WIC)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

WIC + grocery delivery

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

Group Type: EXPERIMENTAL

Grocery delivery

Intervention Type: BEHAVIORAL

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 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.

Group Type: EXPERIMENTAL

Grocery delivery

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Unsweetened beverage delivery

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 26 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Tammy Chang

Assistant Professor of Family Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tammy Chang, MD, MPH, MS

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

The University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Marika Waselewski

Role: CONTACT

marikag@umich.edu

734-237-3233

Facility Contacts

Marika Waselewski

Role: primary

marikag@med.umich.edu

734-237-3233

References

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.

Reference Type: DERIVED

PMID: 35930351 (View on PubMed)

Other Identifiers

1R01HD101522

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00190614

Identifier Type: -

Identifier Source: org_study_id