N/A
N=148
Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT01868230 ↗Enrolled (actual)
148
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Gestational Weight Gain — 7.9; 10.4 kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lifestyle Intervention (Behavioral)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- Female
- Sponsor
- University of Massachusetts, Amherst
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gestational Weight Gain |
7.9; 10.4 | — |
| PRIMARY Postpartum Weight Change |
3.2; 3.2; 3.9; 5.7; 6.4; 8.4 | — |
| PRIMARY Percent of Participants Meeting Postpartum Weight Goals |
12; 9; 12; 7; 12; 6 | — |
| PRIMARY Fasting Glucose (FG) |
85.22; 83.89; 87.41; 84.92; 87.41; 91.52 | — |
| PRIMARY Fasting Insulin |
14.65; 20.57; 21.37; 26.53; 16.67; 21.54 | — |
| PRIMARY Hemoglobin A1c (HbA1c) |
5.08; 5.04; 5.19; 5.20; 5.18; 5.13 | — |
| PRIMARY Adiponectin |
3.19; 3.41; 3.18; 2.94; 3.09; 3.55 | — |
| PRIMARY Total Leptin |
44.51; 50.13; 44.64; 52.28; 42.44; 42.39 | — |
| PRIMARY Total Cholesterol |
167.75; 162.28; 165.18; 153.96; 164.41; 147.29 | — |
| PRIMARY Low Density Lipoprotein Cholesterol |
108.27; 101.03; 103.85; 96.52; 105.79; 91.60 | — |
| PRIMARY High Density Lipoprotein Cholesterol. |
42.75; 43.50; 48.12; 42.04; 47.53; 42.52 | — |
| PRIMARY Triglycerides |
94.08; 101.94; 99.19; 92.73; 88.38; 85.90 | — |
| PRIMARY High Sensitivity C-Reactive Protein |
4.63; 7.02; 6.62; 7.08; 6.48; 5.50 | — |
| PRIMARY Compliance With IOM Weight Gain Guidelines for Pregnancy. |
13; 12; 9; 13; 41; 45 | — |
| PRIMARY Child Waist Circumference |
41; 41 | — |
| PRIMARY Child Head Circumference |
55; 54.9 | — |
| PRIMARY Child Skinfold Thicknesses - Subcapsular and Triceps |
8.8; 9.1; 10.4; 10.1 | — |
| PRIMARY Fetal Growth |
0.21; -0.08 | — |
| PRIMARY Ponderal Index |
3.15; 2.89 | — |
| PRIMARY Birthweight |
3300.2; 3247.3 | — |
| PRIMARY Child Length |
23.5; 24.0 | — |
| SECONDARY Physical Activity |
13; 8; 44; 58 | — |
Summary
The overall goal of this randomized controlled trial is to test the efficacy of a culturally and linguistically modified, individually tailored lifestyle intervention to reduce excess gestational weight gain (GWG), increase postpartum weight loss, and improve maternal metabolic status among overweight/obese Hispanic women.
Eligibility Criteria
Inclusion Criteria
- Hispanic women
- Overweight or obese before pregnancy (BMI >25 kg/m2)
- 16-45 years old
Exclusion Criteria
- prepregnancy BMI 16 wks gestation
- current medications which adversely influence glucose tolerance
- not planning to continue to term or deliver at the study site
- pregnant with twins or triplets
Data sourced from ClinicalTrials.gov (NCT01868230). 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.