Diabetes
Conditions
Brief 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.
Detailed description
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. Specific aims are to evaluate the impact of the intervention on 1) GWG and postpartum weight loss, 2) pregnancy and postpartum biomarkers of insulin resistance (i.e., glucose, insulin, HbA1c, HOMA, leptin, adiponectin), 3) postpartum biomarkers of cardiovascular risk (i.e., blood lipids, blood pressure), 4) offspring outcomes (i.e., anthropometric measures and biomarkers of insulin resistance), and 5) to evaluate the cost-effectiveness of the intervention per average incremental improvement in the outcome variables. Overweight/obese Hispanic women will be recruited in early pregnancy (around 10 wks gestation) and randomly assigned to a Lifestyle Intervention (n=150) or a Comparison Health and Wellness (control) Intervention (n=150). The intervention will utilize exercise (R01NR011295) and dietary intervention materials (R18DK067549) culturally adapted for Hispanics and shown to be efficacious in our previous controlled trials in this ethnic group. Multimodal contacts (i.e., in-person, telephone counseling, and mailed print-based materials) will be used to deliver the intervention during pregnancy (\ 12 wks gestation to delivery) continuing into postpartum (\ 6 wks to 6 mos postpartum); follow-up will continue for one year postpartum. Targets of the intervention are to achieve Institute of Medicine Guidelines for GWG and postpartum weight loss; ACOG guidelines for physical activity through increasing walking and developing a more active lifestyle; and reduction in total calories by following a balanced healthy diet in compliance with American Diabetes Association guidelines. The intervention draws from Social Cognitive Theory and the Transtheoretical Model and includes strategies for partner and/or family support to address the specific social, cultural, and economic challenges faced by underserved Hispanic women. Measures of compliance will include actigraphs and Hispanic food frequency questionnaires. The proposed project builds upon the expertise of the investigative team in conducting randomized controlled trials of exercise interventions among Hispanic pregnant women (R01 DK074876) and dietary interventions among low-income Hispanics with type 2 diabetes (R18 DK0658850) and can readily be translated into clinical practice in underserved and minority populations.
Interventions
BEHAVIORALLifestyle Intervention
Sponsors
University of Massachusetts, Amherst
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of California, San Diego
Northeastern University
Baystate Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Hispanic women * Overweight or obese before pregnancy (BMI \>25 kg/m2) * 16-45 years old
Exclusion criteria
* prepregnancy BMI \<25 kg/m2 * history of type 2 diabetes, heart disease, or chronic renal disease * contraindications to postpartum participation in moderate physical activity or a low-fat/high-fiber diet (e.g., Crohn's disease, ulcerative colitis) * inability to read English or Spanish at a 6th grade level * \>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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Cholesterol | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Gestational Weight Gain | delivery | Gestational weight change will be measured as the difference between weight at delivery and prepregnancy weight as abstracted from the medical record. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline. |
| Postpartum Weight Change | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline. |
| Percent of Participants Meeting Postpartum Weight Goals | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Postpartum weight goals will be defined as a 5% reduction from prepregnancy weight. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline. |
| Fasting Glucose (FG) | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Fasting Insulin | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Hemoglobin A1c (HbA1c) | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Adiponectin | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Total Leptin | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified "two-step" sandwich-type immunoassay (R\&D Systems, Minneapolis, MN) (pg/mL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Low Density Lipoprotein Cholesterol | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| High Density Lipoprotein Cholesterol. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Triglycerides | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| High Sensitivity C-Reactive Protein | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. |
| Compliance With IOM Weight Gain Guidelines for Pregnancy. | delivery | Compliance with IOM weight gain guidelines during pregnancy is measured by comparing the observed gestational weight gain (GWG) with the 2009 IOM Guidelines. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing weights were imputed in the manner of prior trials with the use of 10 random multivariate imputations based on observed variables at baseline. Total GWG was calculated by subtracting pre-pregnancy weight from weight at delivery and was categorized as "below," "within," or "above" IOM guidelines based on the IOM's 2009 GWG guidelines: specifically, women with an underweight BMI are advised to gain a total of 28-40 lbs, women with a BMI in the normal weight category are advised to gain 25-35 lbs., women with a BMI in the overweight category are advised to gain 15-25 lbs, and women with a BMI in the obese category are advised to gain 11-20 lbs. |
| Child Waist Circumference | delivery | measuring tape |
| Child Head Circumference | delivery | measuring tape |
| Child Skinfold Thicknesses - Subcapsular and Triceps | delivery | calipers |
| Fetal Growth | delivery | Birthweight-for-gestational age z-scores will be calculated by subtracting the mean and dividing by the standard deviation from a standardization population (specifically, the 2014 Natality data from National Center for Health Statistics using data limited to Hispanic ethnicity). A Z-score of 0 represents the population mean. Z score values \<0 represent scores lower than the population average observed in the standardization population. It remains to be established which z score range (percentile and SD) is associated with optimal short- and long-term offspring health. |
| Ponderal Index | delivery | The ponderal index is calculated as birth weight (g) x 100/birth length (cm). A lower ponderal index is typically used to identify neonates that were affected by intrauterine growth restriction. For example, ponderal indexes between 2.5 and 3.0 are generally considered normal, between 2.0 and 2.5 marginal, and less than 2.0 low (unhealthy). |
| Birthweight | delivery | scale |
| Child Length | delivery | measuring tape |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity | 6 weeks postpartum, 6 months postpartum, 12 months postpartum | Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ). The American College of Gynecologists (ACOG) recommend that pregnant women obtain at least 30 minutes of moderate-intensity PA on most days of the week during pregnancy and postpartum. Therefore, meeting ACOG guidelines will be defined as women who obtain at least 150 minutes of moderate to vigorous intensity activity during exercise. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLisa Chasan-Taber, ScD
University of Massachusetts, Amherst
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lifestyle Intervention Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention | 74 |
| Health and Wellness HW served as the comparison group and received the same number of in-person sessions, telephone calls, and mailings at the same time points as LI. Content was limited to general information available to the public from the ACOG and the American Academy of Pediatrics and did not mention exercise behavior change. | 74 |
| Total | 148 |
Baseline characteristics
| Characteristic | Lifestyle Intervention | Health and Wellness | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 64 Participants | 63 Participants | 127 Participants |
| BMI | 33.8 kg/m2 STANDARD_DEVIATION 6.7 | 33.3 kg/m2 STANDARD_DEVIATION 7.6 | 33.5 kg/m2 STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 74 Participants | 74 Participants | 148 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 74 participants | 74 participants | 148 participants |
| Sex: Female, Male Female | 74 Participants | 74 Participants | 148 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 74 | 0 / 74 |
| other Total, other adverse events | 0 / 74 | 0 / 74 |
| serious Total, serious adverse events | 0 / 74 | 0 / 74 |
Outcome results
Primary
Adiponectin
Total Adiponectin (Multimeric) will be measured using an ELISA method from ALPCO Diagnostics Inc. (Salem, NH). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Adiponectin | 6 wks postpartum | 3.19 ng/ml | Standard Deviation 1.63 |
| Lifestyle Intervention | Adiponectin | 6 mos postpartum | 3.18 ng/ml | Standard Deviation 1.64 |
| Lifestyle Intervention | Adiponectin | 12 mos postpartum | 3.09 ng/ml | Standard Deviation 1.54 |
| Health and Wellness | Adiponectin | 6 wks postpartum | 3.41 ng/ml | Standard Deviation 1.71 |
| Health and Wellness | Adiponectin | 6 mos postpartum | 2.94 ng/ml | Standard Deviation 1.76 |
| Health and Wellness | Adiponectin | 12 mos postpartum | 3.55 ng/ml | Standard Deviation 2.07 |
Primary
Birthweight
scale
Time frame: delivery
Population: Anthropometric measures not available for the remainder of the randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Birthweight | 3300.2 grams | Standard Deviation 556.7 |
| Health and Wellness | Birthweight | 3247.3 grams | Standard Deviation 600.3 |
Primary
Child Head Circumference
measuring tape
Time frame: delivery
Population: Anthropometric measures not available for the remainder of the randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Child Head Circumference | 55 cm | Standard Deviation 4.6 |
| Health and Wellness | Child Head Circumference | 54.9 cm | Standard Deviation 4.5 |
Primary
Child Length
measuring tape
Time frame: delivery
Population: Anthropometric measures not available for the remainder of the randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Child Length | 23.5 cm | Standard Deviation 2.6 |
| Health and Wellness | Child Length | 24.0 cm | Standard Deviation 4.2 |
Primary
Child Skinfold Thicknesses - Subcapsular and Triceps
calipers
Time frame: delivery
Population: Anthropometric measures not available for the remainder of the randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Child Skinfold Thicknesses - Subcapsular and Triceps | subcapsular | 8.8 mm | Standard Deviation 2.5 |
| Lifestyle Intervention | Child Skinfold Thicknesses - Subcapsular and Triceps | triceps | 10.4 mm | Standard Deviation 10.1 |
| Health and Wellness | Child Skinfold Thicknesses - Subcapsular and Triceps | subcapsular | 9.1 mm | Standard Deviation 2.4 |
| Health and Wellness | Child Skinfold Thicknesses - Subcapsular and Triceps | triceps | 10.1 mm | Standard Deviation 2.9 |
Primary
Child Waist Circumference
measuring tape
Time frame: delivery
Population: Anthropometric measures not available for the remainder of the randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Child Waist Circumference | 41 cm | Standard Deviation 4.5 |
| Health and Wellness | Child Waist Circumference | 41 cm | Standard Deviation 4.49 |
Primary
Compliance With IOM Weight Gain Guidelines for Pregnancy.
Compliance with IOM weight gain guidelines during pregnancy is measured by comparing the observed gestational weight gain (GWG) with the 2009 IOM Guidelines. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing weights were imputed in the manner of prior trials with the use of 10 random multivariate imputations based on observed variables at baseline. Total GWG was calculated by subtracting pre-pregnancy weight from weight at delivery and was categorized as below, within, or above IOM guidelines based on the IOM's 2009 GWG guidelines: specifically, women with an underweight BMI are advised to gain a total of 28-40 lbs, women with a BMI in the normal weight category are advised to gain 25-35 lbs., women with a BMI in the overweight category are advised to gain 15-25 lbs, and women with a BMI in the obese category are advised to gain 11-20 lbs.
Time frame: delivery
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Intervention | Compliance With IOM Weight Gain Guidelines for Pregnancy. | Below IOM Guidelines | 13 Participants |
| Lifestyle Intervention | Compliance With IOM Weight Gain Guidelines for Pregnancy. | Within IOM Guidelines | 9 Participants |
| Lifestyle Intervention | Compliance With IOM Weight Gain Guidelines for Pregnancy. | Above IOM Guidelines | 41 Participants |
| Lifestyle Intervention | Compliance With IOM Weight Gain Guidelines for Pregnancy. | missing | 11 Participants |
| Health and Wellness | Compliance With IOM Weight Gain Guidelines for Pregnancy. | missing | 4 Participants |
| Health and Wellness | Compliance With IOM Weight Gain Guidelines for Pregnancy. | Below IOM Guidelines | 12 Participants |
| Health and Wellness | Compliance With IOM Weight Gain Guidelines for Pregnancy. | Above IOM Guidelines | 45 Participants |
| Health and Wellness | Compliance With IOM Weight Gain Guidelines for Pregnancy. | Within IOM Guidelines | 13 Participants |
Primary
Fasting Glucose (FG)
Fasting Glucose (FG) will be measured enzymatically on the Roche P Modular system using Roche Diagnostics reagents (Indianapolis, IN)(mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Fasting Glucose (FG) | 6 wks postpartum | 85.22 mg/dL | Standard Deviation 9.77 |
| Lifestyle Intervention | Fasting Glucose (FG) | 6 mos postpartum | 87.41 mg/dL | Standard Deviation 13.71 |
| Lifestyle Intervention | Fasting Glucose (FG) | 12 mos postpartum | 87.41 mg/dL | Standard Deviation 8.16 |
| Health and Wellness | Fasting Glucose (FG) | 6 wks postpartum | 83.89 mg/dL | Standard Deviation 11.39 |
| Health and Wellness | Fasting Glucose (FG) | 6 mos postpartum | 84.92 mg/dL | Standard Deviation 14.64 |
| Health and Wellness | Fasting Glucose (FG) | 12 mos postpartum | 91.52 mg/dL | Standard Deviation 12.47 |
Primary
Fasting Insulin
Fasting Insulin (FI) will be measured by an electrochemiluminescence immunoassay on the Roche E Modular system in uU/mL. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Fasting Insulin | 6 wks postpartum | 14.65 iU/mL | Standard Deviation 7.65 |
| Lifestyle Intervention | Fasting Insulin | 6 mos postpartum | 21.37 iU/mL | Standard Deviation 18.38 |
| Lifestyle Intervention | Fasting Insulin | 12 mos postpartum | 16.67 iU/mL | Standard Deviation 8.83 |
| Health and Wellness | Fasting Insulin | 6 wks postpartum | 20.57 iU/mL | Standard Deviation 21.4 |
| Health and Wellness | Fasting Insulin | 6 mos postpartum | 26.53 iU/mL | Standard Deviation 16.22 |
| Health and Wellness | Fasting Insulin | 12 mos postpartum | 21.54 iU/mL | Standard Deviation 16.86 |
Primary
Fetal Growth
Birthweight-for-gestational age z-scores will be calculated by subtracting the mean and dividing by the standard deviation from a standardization population (specifically, the 2014 Natality data from National Center for Health Statistics using data limited to Hispanic ethnicity). A Z-score of 0 represents the population mean. Z score values \<0 represent scores lower than the population average observed in the standardization population. It remains to be established which z score range (percentile and SD) is associated with optimal short- and long-term offspring health.
Time frame: delivery
Population: Anthropometric measures not available for the remainder of the randomized participants.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Fetal Growth | 0.21 z score | Standard Deviation 1.2 |
| Health and Wellness | Fetal Growth | -0.08 z score | Standard Deviation 1.2 |
Primary
Gestational Weight Gain
Gestational weight change will be measured as the difference between weight at delivery and prepregnancy weight as abstracted from the medical record. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Time frame: delivery
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Lifestyle Intervention | Gestational Weight Gain | 7.9 kg |
| Health and Wellness | Gestational Weight Gain | 10.4 kg |
Primary
Hemoglobin A1c (HbA1c)
The Hemoglobin A1c (HbA1c) determination on the Roche P Modular system will be based on turbidimetric immunoinhibition using packed red cells. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Hemoglobin A1c (HbA1c) | 6 wks postpartum | 5.08 % of HbA1c | Standard Deviation 0.29 |
| Lifestyle Intervention | Hemoglobin A1c (HbA1c) | 6 mos postpartum | 5.19 % of HbA1c | Standard Deviation 0.31 |
| Lifestyle Intervention | Hemoglobin A1c (HbA1c) | 12 mos postpartum | 5.18 % of HbA1c | Standard Deviation 0.33 |
| Health and Wellness | Hemoglobin A1c (HbA1c) | 6 wks postpartum | 5.04 % of HbA1c | Standard Deviation 0.35 |
| Health and Wellness | Hemoglobin A1c (HbA1c) | 6 mos postpartum | 5.20 % of HbA1c | Standard Deviation 0.26 |
| Health and Wellness | Hemoglobin A1c (HbA1c) | 12 mos postpartum | 5.13 % of HbA1c | Standard Deviation 0.31 |
Primary
High Density Lipoprotein Cholesterol.
The concentration of High Density Lipoprotein Cholesterol will be determined using a direct enzymatic colorimetric assay (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of the randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | High Density Lipoprotein Cholesterol. | 6 wks postpartum | 42.75 mg/dL | Standard Deviation 6.85 |
| Lifestyle Intervention | High Density Lipoprotein Cholesterol. | 6 mos postpartum | 48.12 mg/dL | Standard Deviation 19.91 |
| Lifestyle Intervention | High Density Lipoprotein Cholesterol. | 12 mos postpartum | 47.53 mg/dL | Standard Deviation 11.54 |
| Health and Wellness | High Density Lipoprotein Cholesterol. | 6 wks postpartum | 43.50 mg/dL | Standard Deviation 9.45 |
| Health and Wellness | High Density Lipoprotein Cholesterol. | 6 mos postpartum | 42.04 mg/dL | Standard Deviation 8.58 |
| Health and Wellness | High Density Lipoprotein Cholesterol. | 12 mos postpartum | 42.52 mg/dL | Standard Deviation 10.72 |
Primary
High Sensitivity C-Reactive Protein
The concentration of High Sensitivity C-Reactive Protein (hsCRP) will be determined using an immunoturbidimetric assay on the Roche P Modular system using reagents and calibrators from DiaSorin (Stillwater, MN) (mg/L). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of the randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | High Sensitivity C-Reactive Protein | 6 wks postpartum | 4.63 mg/L | Standard Deviation 3.98 |
| Lifestyle Intervention | High Sensitivity C-Reactive Protein | 6 mos postpartum | 6.62 mg/L | Standard Deviation 9.39 |
| Lifestyle Intervention | High Sensitivity C-Reactive Protein | 12 mos postpartum | 6.48 mg/L | Standard Deviation 6.85 |
| Health and Wellness | High Sensitivity C-Reactive Protein | 6 wks postpartum | 7.02 mg/L | Standard Deviation 10.63 |
| Health and Wellness | High Sensitivity C-Reactive Protein | 6 mos postpartum | 7.08 mg/L | Standard Deviation 8.5 |
| Health and Wellness | High Sensitivity C-Reactive Protein | 12 mos postpartum | 5.50 mg/L | Standard Deviation 5.65 |
Primary
Low Density Lipoprotein Cholesterol
Low Density Lipoprotein Cholesterol will be determined by a homogenous direct method (mg/dL).The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of the randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Low Density Lipoprotein Cholesterol | 6 wks postpartum | 108.27 mg/dL | Standard Deviation 29.57 |
| Lifestyle Intervention | Low Density Lipoprotein Cholesterol | 6 mos postpartum | 103.85 mg/dL | Standard Deviation 23.21 |
| Lifestyle Intervention | Low Density Lipoprotein Cholesterol | 12 mos postpartum | 105.79 mg/dL | Standard Deviation 24.35 |
| Health and Wellness | Low Density Lipoprotein Cholesterol | 6 wks postpartum | 101.03 mg/dL | Standard Deviation 29 |
| Health and Wellness | Low Density Lipoprotein Cholesterol | 6 mos postpartum | 96.52 mg/dL | Standard Deviation 26.49 |
| Health and Wellness | Low Density Lipoprotein Cholesterol | 12 mos postpartum | 91.60 mg/dL | Standard Deviation 22.76 |
Primary
Percent of Participants Meeting Postpartum Weight Goals
Postpartum weight goals will be defined as a 5% reduction from prepregnancy weight. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Intervention | Percent of Participants Meeting Postpartum Weight Goals | 6 weeks postpartum | 12 Participants |
| Lifestyle Intervention | Percent of Participants Meeting Postpartum Weight Goals | 6 months postpartum | 12 Participants |
| Lifestyle Intervention | Percent of Participants Meeting Postpartum Weight Goals | 12 months postpartum | 12 Participants |
| Health and Wellness | Percent of Participants Meeting Postpartum Weight Goals | 6 weeks postpartum | 9 Participants |
| Health and Wellness | Percent of Participants Meeting Postpartum Weight Goals | 6 months postpartum | 7 Participants |
| Health and Wellness | Percent of Participants Meeting Postpartum Weight Goals | 12 months postpartum | 6 Participants |
Primary
Ponderal Index
The ponderal index is calculated as birth weight (g) x 100/birth length (cm). A lower ponderal index is typically used to identify neonates that were affected by intrauterine growth restriction. For example, ponderal indexes between 2.5 and 3.0 are generally considered normal, between 2.0 and 2.5 marginal, and less than 2.0 low (unhealthy).
Time frame: delivery
Population: Anthropometric measures not available for the remainder of the randomized participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Ponderal Index | 3.15 g/m^3 | Standard Deviation 1.1 |
| Health and Wellness | Ponderal Index | 2.89 g/m^3 | Standard Deviation 0.96 |
Primary
Postpartum Weight Change
Postpartum weight change will be measured as the difference between weight at 6 or 12 mos postpartum and weight at delivery. Weight will be measured on a digital scale. The analysis involved an intent-to-treat analysis among the entire sample of randomized participants. Missing postpartum weights were imputed in the manner of prior weight loss trials with the use of 10 random multivariate imputations based on observed variables at baseline.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Lifestyle Intervention | Postpartum Weight Change | 6 weeks postpartum | 3.2 kg |
| Lifestyle Intervention | Postpartum Weight Change | 6 months postpartum | 3.9 kg |
| Lifestyle Intervention | Postpartum Weight Change | 12 months postpartum | 6.4 kg |
| Health and Wellness | Postpartum Weight Change | 6 weeks postpartum | 3.2 kg |
| Health and Wellness | Postpartum Weight Change | 6 months postpartum | 5.7 kg |
| Health and Wellness | Postpartum Weight Change | 12 months postpartum | 8.4 kg |
Primary
Total Cholesterol
Lipoprotein Profile: will be simultaneously performed on the Roche P Modular system. Total Cholesterol will be measured enzymatically (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of the randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Total Cholesterol | 12 mos postpartum | 164.41 mg/dL | Standard Deviation 23 |
| Lifestyle Intervention | Total Cholesterol | 6 wks postpartum | 167.75 mg/dL | Standard Deviation 28.61 |
| Lifestyle Intervention | Total Cholesterol | 6 mos postpartum | 165.18 mg/dL | Standard Deviation 26.52 |
| Health and Wellness | Total Cholesterol | 12 mos postpartum | 147.29 mg/dL | Standard Deviation 24.83 |
| Health and Wellness | Total Cholesterol | 6 wks postpartum | 162.28 mg/dL | Standard Deviation 34.79 |
| Health and Wellness | Total Cholesterol | 6 mos postpartum | 153.96 mg/dL | Standard Deviation 27.81 |
Primary
Total Leptin
Leptin will be measured by an ultra-sensitive ELISA assay, an enzymatically amplified two-step sandwich-type immunoassay (R&D Systems, Minneapolis, MN) (pg/mL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Total Leptin | 6 wks postpartum | 44.51 pg/mL | Standard Deviation 16.34 |
| Lifestyle Intervention | Total Leptin | 6 mos postpartum | 44.64 pg/mL | Standard Deviation 28.97 |
| Lifestyle Intervention | Total Leptin | 12 mos postpartum | 42.44 pg/mL | Standard Deviation 21.37 |
| Health and Wellness | Total Leptin | 6 wks postpartum | 50.13 pg/mL | Standard Deviation 22.24 |
| Health and Wellness | Total Leptin | 6 mos postpartum | 52.28 pg/mL | Standard Deviation 29.99 |
| Health and Wellness | Total Leptin | 12 mos postpartum | 42.39 pg/mL | Standard Deviation 16.19 |
Primary
Triglycerides
Triglycerides will be measured enzymatically with correction for endogenous glycerol (mg/dL). The analysis involved an intent-to-treat analysis among the entire sample of randomized participants.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
Population: Biomarker data not provided by the remainder of the randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lifestyle Intervention | Triglycerides | 6 wks postpartum | 94.08 mg/dL | Standard Deviation 49.3 |
| Lifestyle Intervention | Triglycerides | 6 mos postpartum | 99.19 mg/dL | Standard Deviation 61.02 |
| Lifestyle Intervention | Triglycerides | 12 mos postpartum | 88.38 mg/dL | Standard Deviation 35.98 |
| Health and Wellness | Triglycerides | 6 wks postpartum | 101.94 mg/dL | Standard Deviation 49.34 |
| Health and Wellness | Triglycerides | 6 mos postpartum | 92.73 mg/dL | Standard Deviation 45.86 |
| Health and Wellness | Triglycerides | 12 mos postpartum | 85.90 mg/dL | Standard Deviation 46.17 |
Post Hoc
Alternate Healthy Eating Index-Pregnancy (AHEI-P)
Total calories, along with the other nutrients, will be measured via three 24-hr dietary recalls. Alternate Healthy Eating Index-Pregnancy (AHEI-P) scores were calculated. The AHEI-P is a dietary quality index based on a 130-point scale with 0-10 points awarded for optimal intake of six food groups (vegetables; whole fruit; whole grains; sugar-sweetened beverages; nuts and legumes; red/processed meats) and seven nutrient-based categories (trans fats; long-chain fats; PUFA; Na; Ca; folate; Fe). The AHEI range is from 0 to 130 with a higher score indicative of a higher quality diet.
Time frame: mid pregnancy (mean 14.2 [SD 4.3]) weeks gestation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lifestyle Intervention | Alternate Healthy Eating Index-Pregnancy (AHEI-P) | 57.6 units on a scale | Standard Deviation 13.6 |
| Health and Wellness | Alternate Healthy Eating Index-Pregnancy (AHEI-P) | 55.6 units on a scale | Standard Deviation 13.6 |
Post Hoc
Physical Activity
Total activity according to intensity will be measured via the Pregnancy Physical Activity Questionnaire (PPAQ). The American College of Gynecologists (ACOG) recommend that pregnant women obtain at least 30 minutes of moderate-intensity PA on most days of the week during pregnancy and postpartum. Therefore, meeting ACOG guidelines will be defined as women who obtain at least 150 minutes of moderate to vigorous intensity activity during exercise.
Time frame: 6 weeks postpartum, 6 months postpartum, 12 months postpartum
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lifestyle Intervention | Physical Activity | Met ACOG PA guidelines | 24 Participants |
| Lifestyle Intervention | Physical Activity | Did not meet ACOG PA guidelines | 50 Participants |
| Health and Wellness | Physical Activity | Met ACOG PA guidelines | 31 Participants |
| Health and Wellness | Physical Activity | Did not meet ACOG PA guidelines | 43 Participants |