The Blossom Project: "Be-Well" Behavioral Wellness Study in Pregnancy
Completed · Not applicable
Conditions studied: Excessive Weight Gain in Pregnancy With Baby Delivered
In brief
Multiple studies have demonstrated a very low prevalence of women meeting physical activity and weight gain recommendations during pregnancy. The aim of this study is to provide a lifestyle intervention to increase physical activity, reduce carbohydrate intake, prevent excessive gestational weight gain, decrease postpartum weight retention, and improve mental well-being compared to "usual care" using a randomized controlled design in pregnant women. Participants in the intervention group will receive behavioral lifestyle counseling and take part in monthly one-on-one visits with a registered dietitian (RDN) from approximately week 14 of their pregnancy to child birth. Participants in the "usual care" group (control) will not receive any lifestyle counseling. Data collected from this group will be used to compare the effectiveness of the lifestyle intervention. Unlike many studies examining diet and physical activity factors alone, this study evaluates additional psychosocial factors such as psychological health, self-efficacy, competence, motivation and barriers that may influence excessive gestational weight gain. In addition, the Self-Determination Theory framework will be used to measure how motivation and motivational interviewing strategies can help explain changes in volitional behavior.
Key facts
- Study ID
- NCT02168647
- Run by
- Iowa State University
- People needed
- 56
- Starts
- 2015-03-01
- Expected to finish
- 2017-10-01
- Last updated by the study team
- 2018-03-20
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women between the ages of 18-45 with a pre-pregnancy BMI between 18.5-35.0 kg/m2 will be recruited for this study.
- Qualified pregnant women include those participating in a low-active or sedentary lifestyle defined as <3 30-minute exercise sessions per week and therefore, are not currently meeting physical activity guidelines during pregnancy.
- Participants will need to have qualification criteria confirmed by their medical provider prior to beginning the first data collection period.
You may not qualify if…
- Pregnant beyond 14 weeks gestation
- Multiple fetuses
- History of smoking during pregnancy
- History of gestational diabetes mellitus, pre-eclampsia, or chronic disease (e.g. Type 1 diabetes, Type 2 diabetes, heart disease, renal disease, or untreated thyroid conditions)
- Inability to comprehend the information shared during the informed consent process
- Any adverse reactions to armband monitors (e.g. metal allergies, electromagnetic devices)
Where it is running
- Iowa State University — Ames, Iowa, United States
Full record on ClinicalTrials.gov
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