Excessive Gestational Weight Gain, Pregnancy Complications
Conditions
Brief summary
The overarching research question is: "Does the provision of healthy food during pregnancy reduce the proportion of women who experience excessive gestational weight gain compared with standard of care (SoC)?" To answer this question, the investigators will conduct a randomized controlled trial with 400 pregnant women. Participants will be randomized 1:1 to either the Food Provision arm or the SoC arm, with approximately 200 participants per arm. Participants randomized to the SoC arm will receive the standard clinical protocol for nutritional and gestational weight gain counseling recommended for all pregnant women, as well as $500 after delivery to be used specifically for baby items.Those randomized to the Food Provision arm will be provided the same nutritional and gestational weight gain counseling, as well as a total of $1000 during pregnancy to be used specifically for the purchase of healthy foods recommended in the nutritional counseling. Data for the primary outcome will be collected from birth records and from surveys conducted at baseline (pre-intervention), midpoint (between 24-36 weeks gestation), and post-intervention (\ 8 weeks post-partum).
Interventions
BEHAVIORALStandard of Care (SoC)
Standard recommended nutrition and gestational weight gain counseling.
BEHAVIORALFood Provision
Standard recommended nutrition and gestational weight gain counseling plus food provision.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 44 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 16-44 years * \<= 22 weeks Pregnant * Speak English, Spanish, or Marshallese * Valid email address * Resides in and plans to give birth in the state of Arkansas
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excessive Gestational Weight Gain (EGWG) | Baseline to Post-partum (approx. 40 weeks) | Pre-pregnancy weight and weight immediately prior to birth will be used to calculate total weight gain, adjusting for pre-pregnancy body mass index and weeks of gestation. Individuals whose total weight gain exceeds established guidelines will be determined to have EGWG. |
Countries
United States
Outcome results
None listed