Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age14-26
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gestational age ≤ 20 weeks
Text message capability
Healthy singleton pregnancy
Nulliparous
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Grocery delivery
BehavioralEach 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
BehavioralParticipants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake.
Treatment groups
570 Participants
are divided into 3 treatment groupsGroup A: Women, Infants, and Children (WIC)No intervention 0 interventions
Group B: WIC + grocery deliveryExperimental treatment 1 intervention
Group C: WIC + grocery delivery + unsweetened beverage deliveryExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to delivery, approximately 40 weeks2
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.
Time frame
At delivery, approximately 40 weeksSecondary outcomes
1
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.
Time frame
Up to delivery, approximately 40 weeks2
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.
Time frame
Delivery, approximately 40 weeks3
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.
Time frame
Delivery, approximately 40 weeks4
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).
Time frame
Delivery, approximately 40 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Michigan
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov