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

Not Applicable

Recruiting

• Conditions: Weight Gain; Pregnancy
• Interventions: Behavioral: Grocery delivery; Behavioral: Unsweetened beverage delivery

• Registration Number: NCT05000645
• Lead Sponsor: University of Michigan

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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-11
• Study Start: 2021-12-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-24
• Last Update Posted: 2024-01-26
• Primary Completion: 2026-10
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 570

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
WIC + grocery delivery + unsweetened beverage 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.
WIC + grocery delivery	Grocery delivery	Usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.
WIC + grocery delivery + unsweetened beverage delivery	Grocery 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.

Primary Outcome Measures

Name	Time	Method
Weekly weight gain in pregnancy	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	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.

Secondary Outcome Measures

Name	Time	Method
Dietary Quality as measured by the Healthy Eating Index (HEI) Score	Up to delivery, approximately 40 weeks	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.
Occurrence of prenatal complications	Delivery, approximately 40 weeks	Frequency of prenatal complications will be assessed. Complications are collected from mother's medical record examples include gestational diabetes and hypertensive disorders.
Occurrence of delivery complications	Delivery, approximately 40 weeks	Frequency of delivery complications will be assessed. Complications are collected from mother's medical record and include operative delivery, shoulder dystocia, and postpartum hemorrhage.
Baby birth weight	Delivery, approximately 40 weeks	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).

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States