Trial Outcomes & Findings for Lifestyle Intervention in Overweight and Obese Pregnant Hispanic Women (NCT NCT01868230)
NCT ID: NCT01868230
Last Updated: 2024-02-28
Results Overview
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.
COMPLETED
NA
232 participants
delivery
2024-02-28
Participant Flow
Participant milestones
| Measure |
Lifestyle Intervention
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
74
|
74
|
|
Overall Study
6 Week Postpartum Data
|
35
|
41
|
|
Overall Study
6 Month Postpartum Data
|
20
|
33
|
|
Overall Study
12 Months Postpartum
|
22
|
24
|
|
Overall Study
COMPLETED
|
74
|
74
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The primary analysis involved an intent-to-treat analysis among all randomized participants.
Baseline characteristics by cohort
| Measure |
Lifestyle Intervention
n=74 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=74 Participants
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.
|
Total
n=148 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
11 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
21 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Age, Categorical
Between 18 and 65 years
|
64 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
63 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
127 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Sex: Female, Male
Female
|
74 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
74 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
148 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
74 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
74 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
148 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
0 Participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
Region of Enrollment
United States
|
74 participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
74 participants
n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
148 participants
n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
|
BMI
|
33.8 kg/m2
STANDARD_DEVIATION 6.7 • n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
33.3 kg/m2
STANDARD_DEVIATION 7.6 • n=7 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
33.5 kg/m2
STANDARD_DEVIATION 7.1 • n=5 Participants • The primary analysis involved an intent-to-treat analysis among all randomized participants.
|
PRIMARY outcome
Timeframe: deliveryGestational 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.
Outcome measures
| Measure |
Lifestyle Intervention
n=74 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=74 Participants
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.
|
|---|---|---|
|
Gestational Weight Gain
|
7.9 kg
Interval 4.9 to 11.0
|
10.4 kg
Interval 7.4 to 13.3
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPostpartum 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.
Outcome measures
| Measure |
Lifestyle Intervention
n=74 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=74 Participants
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.
|
|---|---|---|
|
Postpartum Weight Change
6 months postpartum
|
3.9 kg
Interval 0.3 to 7.5
|
5.7 kg
Interval 2.2 to 9.1
|
|
Postpartum Weight Change
12 months postpartum
|
6.4 kg
Interval 1.0 to 11.9
|
8.4 kg
Interval 3.6 to 13.2
|
|
Postpartum Weight Change
6 weeks postpartum
|
3.2 kg
Interval 0.2 to 6.2
|
3.2 kg
Interval 0.8 to 5.6
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPostpartum 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.
Outcome measures
| Measure |
Lifestyle Intervention
n=74 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=74 Participants
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.
|
|---|---|---|
|
Percent of Participants Meeting Postpartum Weight Goals
12 months postpartum
|
12 Participants
|
6 Participants
|
|
Percent of Participants Meeting Postpartum Weight Goals
6 weeks postpartum
|
12 Participants
|
9 Participants
|
|
Percent of Participants Meeting Postpartum Weight Goals
6 months postpartum
|
12 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Fasting Glucose (FG)
6 wks postpartum
|
85.22 mg/dL
Standard Deviation 9.77
|
83.89 mg/dL
Standard Deviation 11.39
|
|
Fasting Glucose (FG)
6 mos postpartum
|
87.41 mg/dL
Standard Deviation 13.71
|
84.92 mg/dL
Standard Deviation 14.64
|
|
Fasting Glucose (FG)
12 mos postpartum
|
87.41 mg/dL
Standard Deviation 8.16
|
91.52 mg/dL
Standard Deviation 12.47
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Fasting Insulin
6 wks postpartum
|
14.65 iU/mL
Standard Deviation 7.65
|
20.57 iU/mL
Standard Deviation 21.40
|
|
Fasting Insulin
6 mos postpartum
|
21.37 iU/mL
Standard Deviation 18.38
|
26.53 iU/mL
Standard Deviation 16.22
|
|
Fasting Insulin
12 mos postpartum
|
16.67 iU/mL
Standard Deviation 8.83
|
21.54 iU/mL
Standard Deviation 16.86
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Hemoglobin A1c (HbA1c)
6 wks postpartum
|
5.08 % of HbA1c
Standard Deviation 0.29
|
5.04 % of HbA1c
Standard Deviation 0.35
|
|
Hemoglobin A1c (HbA1c)
6 mos postpartum
|
5.19 % of HbA1c
Standard Deviation 0.31
|
5.20 % of HbA1c
Standard Deviation 0.26
|
|
Hemoglobin A1c (HbA1c)
12 mos postpartum
|
5.18 % of HbA1c
Standard Deviation 0.33
|
5.13 % of HbA1c
Standard Deviation 0.31
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Adiponectin
6 wks postpartum
|
3.19 ng/ml
Standard Deviation 1.63
|
3.41 ng/ml
Standard Deviation 1.71
|
|
Adiponectin
6 mos postpartum
|
3.18 ng/ml
Standard Deviation 1.64
|
2.94 ng/ml
Standard Deviation 1.76
|
|
Adiponectin
12 mos postpartum
|
3.09 ng/ml
Standard Deviation 1.54
|
3.55 ng/ml
Standard Deviation 2.07
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Total Leptin
6 wks postpartum
|
44.51 pg/mL
Standard Deviation 16.34
|
50.13 pg/mL
Standard Deviation 22.24
|
|
Total Leptin
6 mos postpartum
|
44.64 pg/mL
Standard Deviation 28.97
|
52.28 pg/mL
Standard Deviation 29.99
|
|
Total Leptin
12 mos postpartum
|
42.44 pg/mL
Standard Deviation 21.37
|
42.39 pg/mL
Standard Deviation 16.19
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of the randomized participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Total Cholesterol
6 wks postpartum
|
167.75 mg/dL
Standard Deviation 28.61
|
162.28 mg/dL
Standard Deviation 34.79
|
|
Total Cholesterol
6 mos postpartum
|
165.18 mg/dL
Standard Deviation 26.52
|
153.96 mg/dL
Standard Deviation 27.81
|
|
Total Cholesterol
12 mos postpartum
|
164.41 mg/dL
Standard Deviation 23.00
|
147.29 mg/dL
Standard Deviation 24.83
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of the randomized participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Low Density Lipoprotein Cholesterol
6 wks postpartum
|
108.27 mg/dL
Standard Deviation 29.57
|
101.03 mg/dL
Standard Deviation 29.00
|
|
Low Density Lipoprotein Cholesterol
6 mos postpartum
|
103.85 mg/dL
Standard Deviation 23.21
|
96.52 mg/dL
Standard Deviation 26.49
|
|
Low Density Lipoprotein Cholesterol
12 mos postpartum
|
105.79 mg/dL
Standard Deviation 24.35
|
91.60 mg/dL
Standard Deviation 22.76
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of the randomized participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
High Density Lipoprotein Cholesterol.
6 wks postpartum
|
42.75 mg/dL
Standard Deviation 6.85
|
43.50 mg/dL
Standard Deviation 9.45
|
|
High Density Lipoprotein Cholesterol.
6 mos postpartum
|
48.12 mg/dL
Standard Deviation 19.91
|
42.04 mg/dL
Standard Deviation 8.58
|
|
High Density Lipoprotein Cholesterol.
12 mos postpartum
|
47.53 mg/dL
Standard Deviation 11.54
|
42.52 mg/dL
Standard Deviation 10.72
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of the randomized participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
Triglycerides
6 wks postpartum
|
94.08 mg/dL
Standard Deviation 49.30
|
101.94 mg/dL
Standard Deviation 49.34
|
|
Triglycerides
6 mos postpartum
|
99.19 mg/dL
Standard Deviation 61.02
|
92.73 mg/dL
Standard Deviation 45.86
|
|
Triglycerides
12 mos postpartum
|
88.38 mg/dL
Standard Deviation 35.98
|
85.90 mg/dL
Standard Deviation 46.17
|
PRIMARY outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumPopulation: Biomarker data not provided by the remainder of the randomized participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=51 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=58 Participants
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.
|
|---|---|---|
|
High Sensitivity C-Reactive Protein
6 wks postpartum
|
4.63 mg/L
Standard Deviation 3.98
|
7.02 mg/L
Standard Deviation 10.63
|
|
High Sensitivity C-Reactive Protein
6 mos postpartum
|
6.62 mg/L
Standard Deviation 9.39
|
7.08 mg/L
Standard Deviation 8.50
|
|
High Sensitivity C-Reactive Protein
12 mos postpartum
|
6.48 mg/L
Standard Deviation 6.85
|
5.50 mg/L
Standard Deviation 5.65
|
PRIMARY outcome
Timeframe: deliveryCompliance 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.
Outcome measures
| Measure |
Lifestyle Intervention
n=74 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=74 Participants
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.
|
|---|---|---|
|
Compliance With IOM Weight Gain Guidelines for Pregnancy.
Below IOM Guidelines
|
13 Participants
|
12 Participants
|
|
Compliance With IOM Weight Gain Guidelines for Pregnancy.
Within IOM Guidelines
|
9 Participants
|
13 Participants
|
|
Compliance With IOM Weight Gain Guidelines for Pregnancy.
Above IOM Guidelines
|
41 Participants
|
45 Participants
|
|
Compliance With IOM Weight Gain Guidelines for Pregnancy.
missing
|
11 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: deliveryPopulation: Anthropometric measures not available for the remainder of the randomized participants.
measuring tape
Outcome measures
| Measure |
Lifestyle Intervention
n=21 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=21 Participants
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.
|
|---|---|---|
|
Child Waist Circumference
|
41 cm
Standard Deviation 4.5
|
41 cm
Standard Deviation 4.49
|
PRIMARY outcome
Timeframe: deliveryPopulation: Anthropometric measures not available for the remainder of the randomized participants.
measuring tape
Outcome measures
| Measure |
Lifestyle Intervention
n=19 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=19 Participants
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.
|
|---|---|---|
|
Child Head Circumference
|
55 cm
Standard Deviation 4.6
|
54.9 cm
Standard Deviation 4.5
|
PRIMARY outcome
Timeframe: deliveryPopulation: Anthropometric measures not available for the remainder of the randomized participants.
calipers
Outcome measures
| Measure |
Lifestyle Intervention
n=19 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=19 Participants
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.
|
|---|---|---|
|
Child Skinfold Thicknesses - Subcapsular and Triceps
subcapsular
|
8.8 mm
Standard Deviation 2.5
|
9.1 mm
Standard Deviation 2.4
|
|
Child Skinfold Thicknesses - Subcapsular and Triceps
triceps
|
10.4 mm
Standard Deviation 10.1
|
10.1 mm
Standard Deviation 2.9
|
PRIMARY outcome
Timeframe: deliveryPopulation: Anthropometric measures not available for the remainder of the randomized participants.
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.
Outcome measures
| Measure |
Lifestyle Intervention
n=21 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=21 Participants
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.
|
|---|---|---|
|
Fetal Growth
|
0.21 z score
Standard Deviation 1.2
|
-0.08 z score
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: deliveryPopulation: Anthropometric measures not available for the remainder of the randomized participants.
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).
Outcome measures
| Measure |
Lifestyle Intervention
n=21 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=21 Participants
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.
|
|---|---|---|
|
Ponderal Index
|
3.15 g/m^3
Standard Deviation 1.1
|
2.89 g/m^3
Standard Deviation 0.96
|
PRIMARY outcome
Timeframe: deliveryPopulation: Anthropometric measures not available for the remainder of the randomized participants.
scale
Outcome measures
| Measure |
Lifestyle Intervention
n=21 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=21 Participants
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.
|
|---|---|---|
|
Birthweight
|
3300.2 grams
Standard Deviation 556.7
|
3247.3 grams
Standard Deviation 600.3
|
PRIMARY outcome
Timeframe: deliveryPopulation: Anthropometric measures not available for the remainder of the randomized participants.
measuring tape
Outcome measures
| Measure |
Lifestyle Intervention
n=21 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=22 Participants
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.
|
|---|---|---|
|
Child Length
|
23.5 cm
Standard Deviation 2.6
|
24.0 cm
Standard Deviation 4.2
|
POST_HOC outcome
Timeframe: 6 weeks postpartum, 6 months postpartum, 12 months postpartumTotal 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.
Outcome measures
| Measure |
Lifestyle Intervention
n=74 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=74 Participants
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.
|
|---|---|---|
|
Physical Activity
Met ACOG PA guidelines
|
24 Participants
|
31 Participants
|
|
Physical Activity
Did not meet ACOG PA guidelines
|
50 Participants
|
43 Participants
|
POST_HOC outcome
Timeframe: mid pregnancy (mean 14.2 [SD 4.3]) weeks gestationTotal 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.
Outcome measures
| Measure |
Lifestyle Intervention
n=74 Participants
Stage-matched physical activity and diet intervention materials and health education.
Lifestyle Intervention
|
Health and Wellness
n=74 Participants
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.
|
|---|---|---|
|
Alternate Healthy Eating Index-Pregnancy (AHEI-P)
|
57.6 units on a scale
Standard Deviation 13.6
|
55.6 units on a scale
Standard Deviation 13.6
|
Adverse Events
Lifestyle Intervention
Health and Wellness
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Lisa Chasan-Taber, Principal Investigator
UMass Amherst
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place