Clinical trial NCT05000645: Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
Official title: Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy
Weight Gain
Keywords: WIC
Low-income
Diet
Sugar sweetened beverages
Grocery delivery
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2021-08-11
Enrollment: 570
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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)

Primary outcomes:
measure: Weekly weight gain in pregnancy
timeFrame: Up to delivery, approximately 40 weeks
measure: Total weight gain in pregnancy
timeFrame: At delivery, approximately 40 weeks
Secondary outcomes:
measure: Dietary Quality as measured by the Healthy Eating Index (HEI) Score
timeFrame: Up to delivery, approximately 40 weeks
measure: Occurrence of prenatal complications
timeFrame: Delivery, approximately 40 weeks
measure: Occurrence of delivery complications
timeFrame: Delivery, approximately 40 weeks
measure: Baby birth weight
timeFrame: Delivery, approximately 40 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Tammy Chang, MD, MPH, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.