Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Grocery delivery, Unsweetened beverage delivery.
- Who it may be relevant to
- Registry conditions: Pregnancy, Weight Gain. Basic parameters: 14 years — 26 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- 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. - Behavioral Unsweetened beverage delivery
Participants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake.
Primary outcome measures
- 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]
Secondary outcome measures (4)
- Dietary Quality as measured by the Healthy Eating Index (HEI) Score [Time frame: Up to delivery, approximately 40 weeks]
- Occurrence of prenatal complications [Time frame: Delivery, approximately 40 weeks]
- Occurrence of delivery complications [Time frame: Delivery, approximately 40 weeks]
- Baby birth weight [Time frame: Delivery, approximately 40 weeks]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The University of Michigan — Ann Arbor
Publications
- 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. PMID 35930351
Identifiers
NCT: NCT05000645 · HUM00190614 · 1R01HD101522