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| Name | Class |
|---|---|
| Roche Diagnostics GmbH | INDUSTRY |
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The purpose of this study is to find out whether women who have had gestational diabetes mellitus (GDM) will make healthier lifestyle choices, achieve weight goals, and complete postpartum care assessments after receiving two online classes on healthy nutrition and exercise classes at 6 weeks - 3 months and at 9 months postpartum.
For this pilot study, we propose to conduct a 3-grouped randomized controlled trial to evaluate whether a 1 ½ to 2 hour on-line nutrition and physical activity intervention +/- block testing of blood glucoses fasting and 2 hours after each meal for 4 days/month from starting at 3 months postpartum and concluding at 9 months postpartum will: 1) improve adherence to the receipt of diabetes screening at 12 months postpartum through the recommended 75 gram 2 hour oral glucose tolerance test (OGTT) or fasting blood glucose test, 2) lower glucose values on the 75 gram 2 hour oral glucose tolerance test or fasting blood glucose test and 3) improve attainment of weight loss targets among women with a recent history of GDM.
Patients will participate in an online nutrition and physical activity class from 6 weeks to 3 months and 9 months for women assigned to both groups 2 and 3. For those women assigned to group 3, they will also do block testing using an assigned blood glucose meter and test strips 4 times a day for 4 consecutive days each month, starting at 3 months and ending at 9 months. Women will have the option of submitting meter blood glucose data via e-mailed logs or downloading directly to the clinic using Diasend software. Once downloaded, the Diasend software will create a PDF document with all recorded blood glucose values.
For purposes of this study, we will obtain a Diasend account specific to this study, which will allow women to download blood glucose information with an anonymous unique identifier that can be accessed by the study's Principal Investigator and the Collaborative Institutional Training Initiative (CITI)-certified, International Review Board (IRB)-approved research assistant. Upon accessing the PDF document with the blood glucose meter information, both the PI and the Research Assistant can link blood glucose data with questionnaire and other health information collected in this study through the unique identifiers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care | No Intervention | Standard postpartum care after a pregnancy with gestational diabetes | |
| Standard Care+Education Classes | Experimental | Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes |
|
| Standard Care+Education Classes+Glucose Monitoring | Experimental | Standard postpartum care after a pregnancy with gestational diabetes 2 online nutrition and exercise education classes Self monitoring of blood glucose levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 online nutrition and exercise education classes | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Loss | 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. | 1 year postpartum |
| Postpartum Diabetes Screening at One Year |
| 1 year postpartum |
| Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals | 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. | Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florence Brown, MD | Joslin Diabetes Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Care | Standard postpartum care after a pregnancy with gestational diabetes |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Care | Standard postpartum care after a pregnancy with gestational diabetes |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Weight Loss | 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. | Posted | Count of Participants | Participants | 1 year postpartum |
|
1 year
No adverse events were reported or documented for this study, as it was an education-intervention study that only required survey answers over the course of 1 year (3 month, 6 month, 9 month, 1 year).
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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 | Standard Care | Standard postpartum care after a pregnancy with gestational diabetes |
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Difficulty enrolling and retaining patients for the study; high survey completion but lack of online intervention education modules completion; lack of patient follow up with primary care provider for weights and glucose 1yr postpartum; pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Florence Brown | Joslin Diabetes Center | 617-309-2675 | Florence.Brown@joslin.harvard.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 | Nov 20, 2015 | Aug 30, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2014 | Aug 30, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| Self monitoring of blood glucose levels | Behavioral | 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 |
|
| 3 months, 6 months, 9 months, all reported |
| Food Frequency Questionnaire | The table shows the percent of women eating each food daily or nearly daily. | 3 months, 6 months, 9 months, all reported |
| Exercise Frequency in Women With Gestational Diabetes Post-Partum | This table below shows the average hours per week spent on each activity. | 3 months, 6 months, 9 months, all reported |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Women with a History of Gestational Diabetes | Count of Participants | Participants |
|
| OG002 | 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 |
|
|
| Primary | Postpartum Diabetes Screening at One Year |
| Posted | Count of Participants | Participants | 1 year postpartum |
|
|
|
| Primary | Barriers Associated With Poorer Adherence to Diabetes Screening Guidelines and Weight Loss Goals | 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. | 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 | Posted | Mean | Standard Deviation | score on a scale | Assessed at 6 weeks to 3 months, 6 months, 9 months, and 12 months, 6 months reported |
|
|
|
| Secondary | Dietary Pattern Assessment of Women With Gestational Diabetes Postpartum | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months, 9 months, all reported |
|
|
|
| Secondary | Food Frequency Questionnaire | The table shows the percent of women eating each food daily or nearly daily. | 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. | Posted | Number | % women eating food daily or near daily | 3 months, 6 months, 9 months, all reported |
|
|
|
| Secondary | Exercise Frequency in Women With Gestational Diabetes Post-Partum | This table below shows the average hours per week spent on each activity. | 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. | Posted | Mean | Standard Deviation | average hours per week | 3 months, 6 months, 9 months, all reported |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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 | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | 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 | 0 | 12 | 0 | 12 | 0 | 12 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001519 | Behavior |
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| Fear of Diabetes Diagnosis & PP Depression |
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| Difficulty of Accessing Medical Care |
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| Dissatisfaction with Medical Care |
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| Frequency of Unhealthy Food (3 month) |
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| Frequency of Neutral Food (3 month) |
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| Frequency of Healthy Food (6 month) |
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| Frequency of Unhealthy Food (6 month) |
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| Frequency of Neutral Food (6 month) |
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| Frequency of Healthy Food (9 month) |
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| Frequency of Unhealthy Food (9 month) |
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| Frequency of Neutral Food (9 month) |
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| Leafy Greens (6 months) |
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| Leafy Greens (9 months) |
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| Other Veg (3 months) |
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| Other Veg (6 months) |
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| Other Veg (9 months) |
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| Citrus (3 months) |
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| Citrus (6 months) |
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| Citrus (9 months) |
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| Fruit (3 months) |
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| Fruit (6 months) |
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| Fruit (9 months) |
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| Whole Milk (3 months) |
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| Whole Milk (6 months) |
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| Whole Milk (9 months) |
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| Low Fat Milk (3 months) |
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| Low Fat Milk (6 months) |
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| Low Fat Milk (9 months) |
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| Eggs (3 months) |
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| Eggs (6 months) |
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| Eggs (9 months) |
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| Whole Grain (3 months) |
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| Whole Grain (6 months) |
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| Whole Grain (9 months) |
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| Pasta (3 months) |
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| Pasta (6 months) |
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| Pasta (9 months) |
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| Baked Goods (3 months) |
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| Baked Goods (6 months) |
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| Baked Goods (9 months) |
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| Beef (3 months) |
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| Beef (6 months) |
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| Beef (9 months) |
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| Processed Meat (3 months) |
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| Processed Meat (6 months) |
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| Processed Meat (9 months) |
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| Deep Fried Food (3 months) |
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| Deep Fried Food (6 months) |
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| Deep Fried Food (9 months) |
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| Canned Tuna (3 months) |
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| Canned Tuna (6 months) |
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| Canned Tuna (9 months) |
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| Dark Fish (3 months) |
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| Dark Fish (6 months) |
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| Dark Fish (9 months) |
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| Other Fish (3 months) |
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| Other Fish (6 months) |
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| Other Fish (9 months) |
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| Chicken/Turkey (3 months) |
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| Chicken/Turkey (6 months) |
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| Chicken/Turkey (9 months) |
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| Other Seafood (3 months) |
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| Other Seafood (6 months) |
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| Other Seafood (9 months) |
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| Walking (6 months) |
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| Walking (9 months) |
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| Jogging (3 months) |
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| Jogging (6 months) |
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| Jogging (9 months) |
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| Running (3 month) |
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| Running (6 month) |
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| Running (9 month) |
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| Bicycling (3 months) |
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| Bicycling (6 months) |
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| Bicycling (9 months) |
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| Other Aerobic (3 month) |
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| Other Aerobic (6 month) |
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| Other Aerobic (9 month) |
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| Yoga/Stretching (3 months) |
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| Yoga/Stretching (6 months) |
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| Yoga/Stretching (9 months) |
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| Other Vigorous Activity (3 months) |
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| Other Vigorous Activity (6 months) |
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| Other Vigorous Activity (9 months) |
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| Arm Weights (3 months) |
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| Arm Weights (6 months) |
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| Arm Weights (9 months) |
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| Leg Weights (3 months) |
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| Leg Weights (6 months) |
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| Leg Weights (9 months) |
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| Standing Total (3 months) |
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| Standing Total (6 months) |
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| Standing Total (9 months) |
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| Standing At Home (3 months) |
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| Standing At Home (6 months) |
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| Standing at Home (9 months) |
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| Sitting Total (3 months) |
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| Sitting Total (6 months) |
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| Sitting Total (9 months) |
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| Sitting to Watch TV (3 months) |
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| Sitting to Watch TV (6 months) |
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| Sitting to Watch TV (9 months) |
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| Other Sitting (3 months) |
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| Other Sitting (6 months) |
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| Other Sitting (9 months) |
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