Trial Outcomes & Findings for Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes (NCT NCT01681147)
NCT ID: NCT01681147
Last Updated: 2023-05-12
Results Overview
1\. Postpartum weight loss (target 7% less than the pre-pregnancy weight for overweight/obese women and back to pre-pregnancy weight for normal BMI women). This will be based on medical record information on pre-pregnancy weight and self-reported or health-care provider reported weight at 12 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
1 year postpartum
Results posted on
2023-05-12
Participant Flow
Originally, the number of participants in each of the arms was supposed to be 10 participants per arm. However, due to assignment error, Group 2 only received 8 participants and Group 3 received an additional 2.
Participant milestones
| Measure |
Standard Care+Education Classes+Glucose Monitoring
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
Standard Care
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
10
|
8
|
|
Overall Study
Baseline
|
10
|
9
|
7
|
|
Overall Study
3 Months
|
8
|
8
|
5
|
|
Overall Study
6 Months
|
7
|
7
|
6
|
|
Overall Study
9 Months
|
6
|
7
|
5
|
|
Overall Study
12 Months
|
5
|
5
|
4
|
|
Overall Study
COMPLETED
|
1
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
10
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Barriers to Adherence to Recommended Follow-up in Women With a History of Gestational Diabetes
Baseline characteristics by cohort
| Measure |
Standard Care
n=10 Participants
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
n=8 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
Standard Care+Education Classes+Glucose Monitoring
n=12 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
35.3 years
n=5 Participants
|
35.3 years
n=7 Participants
|
34.6 years
n=5 Participants
|
35.1 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Women with a History of Gestational Diabetes
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 year postpartum1\. Postpartum weight loss (target 7% less than the pre-pregnancy weight for overweight/obese women and back to pre-pregnancy weight for normal BMI women). This will be based on medical record information on pre-pregnancy weight and self-reported or health-care provider reported weight at 12 months.
Outcome measures
| Measure |
Standard Care
n=10 Participants
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
n=8 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
Standard Care+Education Classes+Glucose Monitoring
n=12 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
|---|---|---|---|
|
Weight Loss
|
0 Participants
|
0 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 year postpartum1. Adherence to diabetes screening using the 75 gram 2 hour oral glucose tolerance test (OGTT) or fasting blood glucose at 12 months (+/- 3 months). 2. Lab results from the fasting glucose test or results from a 75 gram 2 hour OGTT at 12 months among women who choose to take the diabetes screening test.
Outcome measures
| Measure |
Standard Care
n=10 Participants
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
n=8 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
Standard Care+Education Classes+Glucose Monitoring
n=12 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
|---|---|---|---|
|
Postpartum Diabetes Screening at One Year
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reportedPopulation: Lack of Self-Care, Infant Care: 1) Not at all 2) Seldom 3) Sometimes 4) Frequently 5) Always. Fear of Diabetes Diagnosis \& PP Depression 1) Most of the time 2) Some of the time 3) Not very often 4) Not at all. Difficulty Accessing Medical Care, Dissatisfaction w/ Medical Care: 1) strongly disagree 2) disagree 3) Neutral 4) Agree 5) Strongly Agree
2\. Determine to what extent barriers to health impact adherence rates to post partum screening and weight loss targets through a web-based questionnaire collected on the 6 weeks to 3 months, 6, 9, and 12 month questionnaires. These questionnaires will assess whether: lack of self care, perception of high infant care giving needs, fear of diabetes diagnosis and postpartum depressive symptoms, difficulty accessing medical care, dissatisfaction with medical care or primary care physician not recommending screening are associated with poorer adherence to diabetes screening guidelines and weight loss goals.
Outcome measures
| Measure |
Standard Care
n=7 Participants
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
n=6 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
Standard Care+Education Classes+Glucose Monitoring
n=7 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
|---|---|---|---|
|
Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
Perception of High Infant Care Giving Needs
|
1.60 score on a scale
Standard Deviation 0.33
|
1.57 score on a scale
Standard Deviation 0.50
|
1.97 score on a scale
Standard Deviation 0.49
|
|
Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
Fear of Diabetes Diagnosis & PP Depression
|
2.99 score on a scale
Standard Deviation 1.09
|
2.93 score on a scale
Standard Deviation 0.97
|
2.83 score on a scale
Standard Deviation 0.87
|
|
Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
Lack of Self-Care
|
2.08 score on a scale
Standard Deviation 0.61
|
2.20 score on a scale
Standard Deviation 0.86
|
2.52 score on a scale
Standard Deviation 0.57
|
|
Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
Difficulty of Accessing Medical Care
|
3.3 score on a scale
Standard Deviation 0.45
|
3.8 score on a scale
Standard Deviation 0.84
|
3.3 score on a scale
Standard Deviation 0.67
|
|
Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals
Dissatisfaction with Medical Care
|
2.96 score on a scale
Standard Deviation 0.89
|
3.08 score on a scale
Standard Deviation 089
|
3.0 score on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 months, all reportedPopulation: Scale was ranked as follows: 1 = Never/Less than once a week; 2 = Once per week; 3 = 2 to 4 times per week; 4 = Nearly daily or daily; 5 = Twice or more per day Patients were asked to rank how often they ate certain types of foods (i.e. starches, vegetables, etc.). Individual questions were categorized into healthy vs. unhealthy neutral foods.
Determine to what extent types of food products and amount of exercise frequented by women with gestational diabetes postpartum impacted adherence rates to weight loss targets through a web-based questionnaire collected at the 3 month, 6 month and 9 month follow-up. These questionnaires will assess whether eating patterns associated with poorer adherence to diabetes screening guidelines and weight loss goals.
Outcome measures
| Measure |
Standard Care
n=10 Participants
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
n=8 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
Standard Care+Education Classes+Glucose Monitoring
n=12 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
|---|---|---|---|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Unhealthy Food (3 month)
|
1.57 score on a scale
Standard Deviation 0.71
|
1.53 score on a scale
Standard Deviation 0.73
|
1.69 score on a scale
Standard Deviation 0.66
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Neutral Food (3 month)
|
1.94 score on a scale
Standard Deviation 0.43
|
1.81 score on a scale
Standard Deviation 0.70
|
1.75 score on a scale
Standard Deviation 0.96
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Healthy Food (6 month)
|
2.52 score on a scale
Standard Deviation 0.94
|
2.54 score on a scale
Standard Deviation 0.83
|
2.46 score on a scale
Standard Deviation 0.96
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Neutral Food (6 month)
|
1.89 score on a scale
Standard Deviation 1.02
|
1.85 score on a scale
Standard Deviation 0.72
|
2.11 score on a scale
Standard Deviation 0.99
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Healthy Food (9 month)
|
2.56 score on a scale
Standard Deviation 0.92
|
2.73 score on a scale
Standard Deviation 0.80
|
2.58 score on a scale
Standard Deviation 0.97
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Unhealthy Food (9 month)
|
1.52 score on a scale
Standard Deviation 0.72
|
1.5 score on a scale
Standard Deviation 0.51
|
1.68 score on a scale
Standard Deviation 0.71
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Unhealthy Food (6 month)
|
1.53 score on a scale
Standard Deviation 0.66
|
1.67 score on a scale
Standard Deviation 0.71
|
1.70 score on a scale
Standard Deviation 0.75
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Neutral Food (9 month)
|
1.89 score on a scale
Standard Deviation 0.98
|
1.91 score on a scale
Standard Deviation 0.93
|
2.04 score on a scale
Standard Deviation 0.87
|
|
Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum
Frequency of Healthy Food (3 month)
|
2.46 score on a scale
Standard Deviation 0.79
|
2.77 score on a scale
Standard Deviation 0.92
|
2.4 score on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 months, all reportedPopulation: The "Overall Number of Participants Analyzed" defines the number of participants enrolled in the study. The Number in the Rows indicates the number of participants that completed the follow-up surveys required for participation in the study.
The table shows the percent of women eating each food daily or nearly daily.
Outcome measures
| Measure |
Standard Care
n=10 Participants
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
n=8 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
Standard Care+Education Classes+Glucose Monitoring
n=12 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
|---|---|---|---|
|
Food Frequency Questionnaire
Other Veg (3 months)
|
25.0 % women eating food daily or near daily
|
40.0 % women eating food daily or near daily
|
25.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Veg (6 months)
|
57.2 % women eating food daily or near daily
|
40.0 % women eating food daily or near daily
|
42.9 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Whole Milk (6 months)
|
42.9 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
57.1 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Whole Milk (9 months)
|
42.9 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
66.7 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Low Fat Milk (3 months)
|
67.5 % women eating food daily or near daily
|
60.0 % women eating food daily or near daily
|
50.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Low Fat Milk (9 months)
|
42.9 % women eating food daily or near daily
|
40.0 % women eating food daily or near daily
|
16.7 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Eggs (3 months)
|
12.5 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
25.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Baked Goods (3 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
25.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Baked Goods (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
42.9 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Baked Goods (9 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
33.3 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Beef (3 months)
|
12.5 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Beef (6 months)
|
28.6 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
14.3 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Fish (9 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Chicken/Turkey (3 months)
|
12.5 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
25.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Chicken/Turkey (6 months)
|
16.7 % women eating food daily or near daily
|
40.0 % women eating food daily or near daily
|
28.6 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Leafy Greens (3 months)
|
87.5 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
50.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Leafy Greens (6 months)
|
57.1 % women eating food daily or near daily
|
60.0 % women eating food daily or near daily
|
42.9 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Leafy Greens (9 months)
|
28.6 % women eating food daily or near daily
|
40.0 % women eating food daily or near daily
|
50.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Veg (9 months)
|
42.9 % women eating food daily or near daily
|
50.0 % women eating food daily or near daily
|
50.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Citrus (3 months)
|
12.5 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Citrus (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Citrus (9 months)
|
0.0 % women eating food daily or near daily
|
60.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Fruit (3 months)
|
25.0 % women eating food daily or near daily
|
80.0 % women eating food daily or near daily
|
25.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Fruit (6 months)
|
28.6 % women eating food daily or near daily
|
60.0 % women eating food daily or near daily
|
42.9 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Fruit (9 months)
|
71.5 % women eating food daily or near daily
|
80.0 % women eating food daily or near daily
|
33.3 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Whole Milk (3 months)
|
25.0 % women eating food daily or near daily
|
60.0 % women eating food daily or near daily
|
62.5 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Low Fat Milk (6 months)
|
57.1 % women eating food daily or near daily
|
40.0 % women eating food daily or near daily
|
28.6 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Eggs (6 months)
|
14.3 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
28.6 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Eggs (9 months)
|
28.6 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
16.7 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Whole Grain (3 months)
|
37.5 % women eating food daily or near daily
|
40.0 % women eating food daily or near daily
|
37.5 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Whole Grain (6 months)
|
57.2 % women eating food daily or near daily
|
60.0 % women eating food daily or near daily
|
71.4 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Whole Grain (9 months)
|
57.1 % women eating food daily or near daily
|
60.0 % women eating food daily or near daily
|
50.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Pasta (3 months)
|
12.5 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
12.5 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Pasta (6 months)
|
0.0 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
14.3 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Pasta (9 months)
|
14.3 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
16.7 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Beef (9 months)
|
28.6 % women eating food daily or near daily
|
0 % women eating food daily or near daily
|
16.7 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Processed Meat (3 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Processed Meat (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Processed Meat (9 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Deep Fried Food (3 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Deep Fried Food (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Deep Fried Food (9 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Canned Tuna (3 months)
|
0.0 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Canned Tuna (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Canned Tuna (9 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Dark Fish (3 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Dark Fish (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Dark Fish (9 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Fish (3 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Fish (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Chicken/Turkey (9 months)
|
28.6 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
33.3 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Seafood (3 months)
|
0.0 % women eating food daily or near daily
|
20.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Seafood (6 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
|
Food Frequency Questionnaire
Other Seafood (9 months)
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
0.0 % women eating food daily or near daily
|
SECONDARY outcome
Timeframe: 3 months, 6 months, 9 months, all reportedPopulation: The "Overall Number of Participants Analyzed" defines the number of participants enrolled in the study. The Number in the Rows indicates the number of participants that completed the follow-up surveys required for participation in the study. The standard deviation represents the SD from the scores on the scale utilized, not the average numbers per week spent on each activity.
This table below shows the average hours per week spent on each activity.
Outcome measures
| Measure |
Standard Care
n=10 Participants
Standard postpartum care after a pregnancy with gestational diabetes
|
Standard Care+Education Classes
n=8 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
|
Standard Care+Education Classes+Glucose Monitoring
n=12 Participants
Standard postpartum care after a pregnancy with gestational diabetes
2 online nutrition and exercise education classes
Self monitoring of blood glucose levels
2 online nutrition and exercise education classes: Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
Self monitoring of blood glucose levels: Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
|
|---|---|---|---|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Sitting to Watch TV (9 months)
|
5.0 average hours per week
Standard Deviation 1.57
|
6.8 average hours per week
Standard Deviation 1.52
|
8.4 average hours per week
Standard Deviation 1.17
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Sitting (3 months)
|
11.5 average hours per week
Standard Deviation 1.28
|
6.2 average hours per week
Standard Deviation 0.58
|
10.0 average hours per week
Standard Deviation 0.71
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Sitting (6 months)
|
6.6 average hours per week
Standard Deviation 1.13
|
7.5 average hours per week
Standard Deviation 0.84
|
6.9 average hours per week
Standard Deviation 0.76
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Walking (6 months)
|
3.0 average hours per week
Standard Deviation 2.99
|
2.2 average hours per week
Standard Deviation 2.74
|
2.6 average hours per week
Standard Deviation 2.24
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Walking (9 months)
|
1.6 average hours per week
Standard Deviation 2.94
|
0.9 average hours per week
Standard Deviation 1.00
|
3.5 average hours per week
Standard Deviation 2.43
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Jogging (3 months)
|
0 average hours per week
Standard Deviation 0.00
|
0.1 average hours per week
Standard Deviation 1.30
|
0.1 average hours per week
Standard Deviation 1.19
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Jogging (6 months)
|
0.2 average hours per week
Standard Deviation 1.73
|
0.2 average hours per week
Standard Deviation 1.30
|
0.03 average hours per week
Standard Deviation 0.76
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Jogging (9 months)
|
0.1 average hours per week
Standard Deviation 1.13
|
0.3 average hours per week
Standard Deviation 1.67
|
0.1 average hours per week
Standard Deviation 1.22
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Running (3 month)
|
0 average hours per week
Standard Deviation 0.00
|
0.01 average hours per week
Standard Deviation 0.45
|
0.1 average hours per week
Standard Deviation 1.06
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Running (6 month)
|
0.1 average hours per week
Standard Deviation 1.13
|
0.01 average hours per week
Standard Deviation 0.55
|
0.03 average hours per week
Standard Deviation 0.79
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Running (9 month)
|
0.1 average hours per week
Standard Deviation 1.46
|
0.04 average hours per week
Standard Deviation 0.89
|
0.1 average hours per week
Standard Deviation 1.22
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Bicycling (3 months)
|
0.1 average hours per week
Standard Deviation 1.41
|
0.0 average hours per week
Standard Deviation 0.00
|
0.0 average hours per week
Standard Deviation 0.00
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Bicycling (9 months)
|
0.4 average hours per week
Standard Deviation 2.27
|
0.3 average hours per week
Standard Deviation 2.24
|
0.0 average hours per week
Standard Deviation 0.00
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Vigorous Activity (9 months)
|
0.9 average hours per week
Standard Deviation 2.75
|
0.7 average hours per week
Standard Deviation 2.00
|
0.5 average hours per week
Standard Deviation 2.07
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Arm Weights (3 months)
|
0.1 average hours per week
Standard Deviation 1.41
|
0.2 average hours per week
Standard Deviation 1.73
|
0.1 average hours per week
Standard Deviation 1.19
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Sitting Total (6 months)
|
20.5 average hours per week
Standard Deviation 1.35
|
20.0 average hours per week
Standard Deviation 1.92
|
28.5 average hours per week
Standard Deviation 1.81
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Sitting Total (9 months)
|
18.4 average hours per week
Standard Deviation 1.21
|
18.4 average hours per week
Standard Deviation 1.95
|
33.6 average hours per week
Standard Deviation 2.43
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Sitting to Watch TV (3 months)
|
6.9 average hours per week
Standard Deviation 1.58
|
4.8 average hours per week
Standard Deviation 0.58
|
13.3 average hours per week
Standard Deviation 1.51
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Walking (3 months)
|
3.4 average hours per week
Standard Deviation 2.8
|
1.7 average hours per week
Standard Deviation 2.35
|
2.2 average hours per week
Standard Deviation 1.85
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Bicycling (6 months)
|
0.2 average hours per week
Standard Deviation 1.89
|
0.1 average hours per week
Standard Deviation 1.34
|
0.1 average hours per week
Standard Deviation 1.13
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Aerobic (3 month)
|
0.0 average hours per week
Standard Deviation 0.12
|
0.0 average hours per week
Standard Deviation 0.00
|
0.0 average hours per week
Standard Deviation 0.00
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Aerobic (6 month)
|
0.3 average hours per week
Standard Deviation 0.60
|
0.03 average hours per week
Standard Deviation 0.30
|
0.02 average hours per week
Standard Deviation 0.25
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Aerobic (9 month)
|
0.1 average hours per week
Standard Deviation 0.50
|
1.2 average hours per week
Standard Deviation 1.88
|
0.4 average hours per week
Standard Deviation 0.66
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Yoga/Stretching (3 months)
|
0.3 average hours per week
Standard Deviation 2.14
|
0.3 average hours per week
Standard Deviation 1.73
|
0.5 average hours per week
Standard Deviation 1.89
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Yoga/Stretching (6 months)
|
0.1 average hours per week
Standard Deviation 1.29
|
1.04 average hours per week
Standard Deviation 2.92
|
0.3 average hours per week
Standard Deviation 1.99
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Yoga/Stretching (9 months)
|
0.1 average hours per week
Standard Deviation 1.13
|
0.6 average hours per week
Standard Deviation 2.68
|
0.4 average hours per week
Standard Deviation 1.67
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Vigorous Activity (3 months)
|
0.5 average hours per week
Standard Deviation 2.31
|
0.3 average hours per week
Standard Deviation 2.12
|
0.4 average hours per week
Standard Deviation 1.93
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Vigorous Activity (6 months)
|
0.2 average hours per week
Standard Deviation 2.04
|
0.9 average hours per week
Standard Deviation 2.77
|
0.4 average hours per week
Standard Deviation 2.24
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Arm Weights (6 months)
|
0.2 average hours per week
Standard Deviation 1.91
|
0.5 average hours per week
Standard Deviation 2.35
|
0.1 average hours per week
Standard Deviation 1.25
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Arm Weights (9 months)
|
0.2 average hours per week
Standard Deviation 1.57
|
0.7 average hours per week
Standard Deviation 2.83
|
0.2 average hours per week
Standard Deviation 1.37
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Leg Weights (3 months)
|
0.004 average hours per week
Standard Deviation 0.35
|
0 average hours per week
Standard Deviation 0.00
|
0.04 average hours per week
Standard Deviation 0.93
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Leg Weights (6 months)
|
0.02 average hours per week
Standard Deviation 0.76
|
0.5 average hours per week
Standard Deviation 2.49
|
0.1 average hours per week
Standard Deviation 1.25
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Leg Weights (9 months)
|
0.0 average hours per week
Standard Deviation 0.00
|
0.7 average hours per week
Standard Deviation 2.83
|
0.3 average hours per week
Standard Deviation 1.76
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Standing Total (3 months)
|
15.9 average hours per week
Standard Deviation 1.30
|
8.8 average hours per week
Standard Deviation 1.00
|
21.0 average hours per week
Standard Deviation 1.51
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Standing Total (6 months)
|
20.8 average hours per week
Standard Deviation 1.63
|
10.6 average hours per week
Standard Deviation 1.58
|
10.5 average hours per week
Standard Deviation 1.17
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Standing Total (9 months)
|
22.7 average hours per week
Standard Deviation 2.29
|
19.2 average hours per week
Standard Deviation 2.07
|
24.7 average hours per week
Standard Deviation 1.22
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Standing At Home (3 months)
|
13.5 average hours per week
Standard Deviation 1.06
|
16.2 average hours per week
Standard Deviation 1.00
|
19.9 average hours per week
Standard Deviation 1.25
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Standing At Home (6 months)
|
21.4 average hours per week
Standard Deviation 1.46
|
11.9 average hours per week
Standard Deviation 1.14
|
11.8 average hours per week
Standard Deviation 0.98
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Standing at Home (9 months)
|
24.4 average hours per week
Standard Deviation 2.56
|
9.1 average hours per week
Standard Deviation 1.00
|
8.9 average hours per week
Standard Deviation 1.47
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Sitting Total (3 months)
|
17.3 average hours per week
Standard Deviation 1.91
|
10.0 average hours per week
Standard Deviation 2.08
|
17.4 average hours per week
Standard Deviation 1.49
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Sitting to Watch TV (6 months)
|
6.2 average hours per week
Standard Deviation 0.84
|
5.5 average hours per week
Standard Deviation 1.58
|
8.6 average hours per week
Standard Deviation 1.38
|
|
Exercise Frequency in Women With Gestational Diabetes Post-Partum
Other Sitting (9 months)
|
3.4 average hours per week
Standard Deviation 1.11
|
4.3 average hours per week
Standard Deviation 0.45
|
6.4 average hours per week
Standard Deviation 1.05
|
Adverse Events
Standard Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care+Education Classes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care+Education Classes+Glucose Monitoring
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place