Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
Primary Purpose
Pregnancy, Weight Gain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grocery delivery
Unsweetened beverage delivery
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy focused on measuring WIC, Low-income, Diet, Sugar sweetened beverages, Grocery 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)
Sites / Locations
- The University of MichiganRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
Women, Infants, and Children (WIC)
WIC + grocery delivery
WIC + grocery delivery + unsweetened beverage delivery
Arm Description
Usual WIC counseling and food benefits for use in person at approved grocery stores.
Usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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).
Full Information
NCT ID
NCT05000645
First Posted
August 3, 2021
Last Updated
March 9, 2023
Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT05000645
Brief Title
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 14-24 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, 855 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 20 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Weight Gain
Keywords
WIC, Low-income, Diet, Sugar sweetened beverages, Grocery delivery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
855 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Women, Infants, and Children (WIC)
Arm Type
No Intervention
Arm Description
Usual WIC counseling and food benefits for use in person at approved grocery stores.
Arm Title
WIC + grocery delivery
Arm Type
Experimental
Arm Description
Usual WIC counseling and food benefits, as well as twice-monthly home deliveries of WIC-approved foods.
Arm Title
WIC + grocery delivery + unsweetened beverage delivery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Grocery delivery
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Unsweetened beverage delivery
Intervention Description
Participants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake.
Primary Outcome Measure Information:
Title
Weekly weight gain in pregnancy
Description
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 weeks
Title
Total weight gain in pregnancy
Description
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 weeks
Secondary Outcome Measure Information:
Title
Dietary Quality as measured by the Healthy Eating Index (HEI) Score
Description
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 weeks
Title
Occurrence of prenatal complications
Description
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 weeks
Title
Occurrence of delivery complications
Description
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 weeks
Title
Baby birth weight
Description
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 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marika Waselewski
Phone
734-998-7124
Email
marikag@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tammy Chang, MD, MPH, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marika Waselewski
Phone
734-998-7124
Email
marikag@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Tammy Chang, MD, MPH, MS
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35930351
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.
Results Reference
derived
Learn more about this trial
Grocery Delivery and Healthy Weight Gain Among Low-income Pregnant Young Women
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