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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05000645
• Other study ID #: HUM00190614
• Secondary ID: 1R01HD101522
• Status: Recruiting
• Phase: N/A
• Start date: December 8, 2021
• Est. completion date: October 2026

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: Marika Waselewski
• Phone: 734-237-3233
• Email: marikag[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 570
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 26 Years

Eligibility

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)

Related Conditions & MeSH terms

• Body Weight
• Pregnancy
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Up to delivery, approximately 40 weeks
Secondary	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.	Delivery, approximately 40 weeks
Secondary	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.	Delivery, approximately 40 weeks
Secondary	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).	Delivery, approximately 40 weeks