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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK097011-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of California, San Diego | OTHER |
| Northeastern University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifestyle Intervention | Experimental | Stage-matched physical activity and diet intervention materials and health education. |
|
| Health and Wellness | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle Intervention | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | delivery |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Chasan-Taber, ScD | University of Massachusetts, Amherst | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31170973 | Derived | Gubrium A, Leckenby D, Harvey MW, Marcus BH, Rosal MC, Chasan-Taber L. Perspectives of health educators and interviewers in a randomized controlled trial of a postpartum diabetes prevention program for Latinas: a qualitative assessment. BMC Health Serv Res. 2019 Jun 6;19(1):357. doi: 10.1186/s12913-019-4207-x. | |
| 26223246 | Derived | Chasan-Taber L, Marcus BH, Rosal MC, Tucker KL, Hartman SJ, Pekow P, Stanek E 3rd, Braun B, Solomon CG, Manson JE, Goff SL, Markenson G. Proyecto Mama: a lifestyle intervention in overweight and obese Hispanic women: a randomised controlled trial--study protocol. BMC Pregnancy Childbirth. 2015 Jul 30;15:157. doi: 10.1186/s12884-015-0575-3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lifestyle Intervention | Stage-matched physical activity and diet intervention materials and health education. Lifestyle Intervention |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The primary analysis involved an intent-to-treat analysis among all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lifestyle Intervention | Stage-matched physical activity and diet intervention materials and health education. Lifestyle Intervention |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The primary analysis involved an intent-to-treat analysis among all randomized participants. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | kg | delivery |
|
AE data collected at follow up visits (delivery, 6 weeks, 6 and 12 months post partum)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lifestyle Intervention | Stage-matched physical activity and diet intervention materials and health education. Lifestyle Intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lisa Chasan-Taber, Principal Investigator | UMass Amherst | 4135451664 | lct@umass.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 9, 2014 | Dec 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Baystate Medical Center |
| OTHER |
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| 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. |
| 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| 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. | delivery |
| Child Waist Circumference | measuring tape | delivery |
| Child Head Circumference | measuring tape | delivery |
| Child Skinfold Thicknesses - Subcapsular and Triceps | calipers | delivery |
| 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. | delivery |
| 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). | delivery |
| Birthweight | scale | delivery |
| Child Length | measuring tape | delivery |
| 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | The primary analysis involved an intent-to-treat analysis among all randomized participants. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | The primary analysis involved an intent-to-treat analysis among all randomized participants. | Count of Participants | Participants |
|
| Region of Enrollment | The primary analysis involved an intent-to-treat analysis among all randomized participants. | Number | participants |
|
| BMI | The primary analysis involved an intent-to-treat analysis among all randomized participants. | Mean | Standard Deviation | kg/m2 |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | kg | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Posted | Count of Participants | Participants | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of participants. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of participants. | Posted | Mean | Standard Deviation | iU/mL | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of participants. | Posted | Mean | Standard Deviation | % of HbA1c | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of participants. | Posted | Mean | Standard Deviation | ng/ml | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of participants. | Posted | Mean | Standard Deviation | pg/mL | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of the randomized participants. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of the randomized participants. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of the randomized participants. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of the randomized participants. | Posted | Mean | Standard Deviation | mg/dL | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Biomarker data not provided by the remainder of the randomized participants. | Posted | Mean | Standard Deviation | mg/L | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Posted | Count of Participants | Participants | delivery |
|
|
|
| Primary | Child Waist Circumference | measuring tape | Anthropometric measures not available for the remainder of the randomized participants. | Posted | Mean | Standard Deviation | cm | delivery |
|
|
|
| Primary | Child Head Circumference | measuring tape | Anthropometric measures not available for the remainder of the randomized participants. | Posted | Mean | Standard Deviation | cm | delivery |
|
|
|
| Primary | Child Skinfold Thicknesses - Subcapsular and Triceps | calipers | Anthropometric measures not available for the remainder of the randomized participants. | Posted | Mean | Standard Deviation | mm | delivery |
|
|
|
| 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. | Anthropometric measures not available for the remainder of the randomized participants. | Posted | Geometric Mean | Standard Deviation | z score | delivery |
|
|
|
| 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). | Anthropometric measures not available for the remainder of the randomized participants. | Posted | Mean | Standard Deviation | g/m^3 | delivery |
|
|
|
| Primary | Birthweight | scale | Anthropometric measures not available for the remainder of the randomized participants. | Posted | Mean | Standard Deviation | grams | delivery |
|
|
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| Primary | Child Length | measuring tape | Anthropometric measures not available for the remainder of the randomized participants. | Posted | Mean | Standard Deviation | cm | delivery |
|
|
|
| Secondary | 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. | The women were randomized to the LI arm (n=74) or the HW comparison arm (n=74) were included in this analysis if they had a measure of early pregnancy physical activity (PA) and at least one subsequent PA measurement over the course of follow-up: A total of 83% of women (77% in the LI arm, n=57 and 89% in the HW arm, n=66) had a measure of early pregnancy PA and at least one subsequent PA measurement. | Posted | Count of Participants | Participants | 6 weeks postpartum, 6 months postpartum, 12 months postpartum |
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | mid pregnancy (mean 14.2 [SD 4.3]) weeks gestation |
|
|
|
| 0 |
| 74 |
| 0 |
| 74 |
| 0 |
| 74 |
| EG001 | 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. | 0 | 74 | 0 | 74 | 0 | 74 |
Not provided
Not provided
| 12 months postpartum |
|
| 12 months postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| 12 mos postpartum |
|
| Above IOM Guidelines |
|
| missing |
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