N/A
N=51
Preventing Excessive Weight Gain and Maternal and Infant Fat Accretion
Gestational Weight Gain · Maternal Fat Accretion · Infant Fat Accretion
Bottom Line
View on ClinicalTrials.gov: NCT04868110 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Maternal Weight Changes — 70.20; 66.47; 80.12; 75.80 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High fiber diet (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maternal Weight Changes |
70.20; 66.47; 80.12; 75.80; 73.53; 67.99 | — |
| PRIMARY Maternal Fat Accretion Changes |
33.49; 32.27; 36.74; 34.91; 36.35; 34.38 | — |
| PRIMARY Identify Changes in Fiber Intake |
19.01; 21.84; 19.35; 35.09; 19.62; 29.71 | — |
| PRIMARY Identify Changes in Dietary Quality |
54.59; 62.51; 50.06; 70.12; 51.43; 62.53 | — |
| SECONDARY Infant Fat Accrual |
17.20; 17.26; 34.89; 32.62 | — |
| SECONDARY Maternal Weight |
71.67; 65.53; 71.65; 64.58 | — |
| SECONDARY Maternal Fat Accretion |
34.79; 30.92; 33.69; 30.81 | — |
| SECONDARY Dietary Fiber Intake |
19.48; 26.94; 17.87; 23.80 | — |
| SECONDARY Dietary Quality |
49.47; 66.05; 48.66; 61.59 | — |
Summary
The purpose of this study is to learn if consuming a high fiber diet will reduce gestational weight gain and maternal and infant fat accretion.
Eligibility Criteria
Inclusion Criteria
- Pre-pregnancy BMI 18.5 - 45.0 kg/m2
Exclusion Criteria
- Comsuming more than 20 g/day of fiber
- No phone and internet access
- Pre-gestational diabetes
- Diagnosed with diabetes
- Pre-eclampsia
- Hypertension
- Other metabolic abnormalities
- Asthma
- Heart disease
- Smoking
- Drug abuse
- Recent antibiotic use
- Pregnancies of multiples
Data sourced from ClinicalTrials.gov (NCT04868110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.