Trial Outcomes & Findings for Personalized Management of Body Weight During Pregnancy (NCT NCT01610752)
NCT ID: NCT01610752
Last Updated: 2021-09-17
Results Overview
Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)
Results posted on
2021-09-17
Participant Flow
Participant milestones
| Measure |
SmartMoms-Clinic
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
17
|
|
Overall Study
COMPLETED
|
18
|
19
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
4
|
Reasons for withdrawal
| Measure |
SmartMoms-Clinic
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Overall Study
Miscarriage/Pregnancy loss
|
0
|
0
|
4
|
Baseline Characteristics
Personalized Management of Body Weight During Pregnancy
Baseline characteristics by cohort
| Measure |
SmartMoms-Clinic
n=18 Participants
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 Participants
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
n=17 Participants
If picked for this group, you will receive weight management advice from your physician's office.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
29.2 years
STANDARD_DEVIATION 4.8 • n=5 Participants
|
29.0 years
STANDARD_DEVIATION 4.2 • n=7 Participants
|
29.5 years
STANDARD_DEVIATION 5.1 • n=5 Participants
|
29.2 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
54 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
|
|
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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
38 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Parity
|
0.7 viable pregnancies
STANDARD_DEVIATION 0.8 • n=5 Participants
|
0.9 viable pregnancies
STANDARD_DEVIATION 1.1 • n=7 Participants
|
0.6 viable pregnancies
STANDARD_DEVIATION 0.5 • n=5 Participants
|
0.8 viable pregnancies
STANDARD_DEVIATION 0.8 • n=4 Participants
|
|
Pregravid BMI
Overweight (25.0-29.9 kg/m2)
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Pregravid BMI
Obese (30.0-40.0 kg/m2)
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Family income per year
<$5000-$39,999
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Family income per year
$40,000-$99,999
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Family income per year
≥$100,000
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Education
Some high school
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Education
High school diploma/GED/1-3 years of college
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Education
College degree
|
7 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Education
Postgraduate work
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)Count of pregnant women who gain more weight during pregnancy than is recommended by the Institute of Medicine Gestational Weight Gain guidelines
Outcome measures
| Measure |
SmartMoms-Clinic
n=18 Participants
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 Participants
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
n=13 Participants
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Count of Women Who Have Excess Gestational Weight Gain
|
10 Participants
|
11 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)Outcome measures
| Measure |
SmartMoms-Clinic
n=18 Participants
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 Participants
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
n=13 Participants
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Total Gestational Weight Gain
|
8.0 kilograms
Standard Error 1.3
|
10.0 kilograms
Standard Error 1.2
|
12.8 kilograms
Standard Error 1.5
|
SECONDARY outcome
Timeframe: Approximately 6 months (from 10-13 weeks gestation to 35-36 weeks gestation)"per week" is included to adjust for the different length of time between weight measurements
Outcome measures
| Measure |
SmartMoms-Clinic
n=18 Participants
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 Participants
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
n=13 Participants
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Gestational Weight Gain Per Week
|
0.31 kilograms per week
Standard Error 0.05
|
0.39 kilograms per week
Standard Error 0.05
|
0.49 kilograms per week
Standard Error 0.06
|
POST_HOC outcome
Timeframe: Approximately 6 months (from 1st trimester until delivery)Costs incurred for travel to and from treatment sessions and time spent with the counselor while accounting for session attendance and intervention adherence. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention.
Outcome measures
| Measure |
SmartMoms-Clinic
n=18 Participants
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 Participants
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Intervention Cost for Participant
|
347 US dollars
Standard Deviation 40
|
97 US dollars
Standard Deviation 6
|
—
|
POST_HOC outcome
Timeframe: Approximately 6 months (from 1st trimester until delivery)Adherence to the SmartMoms intervention was defined as the percentage of days participants weighed and recorded step counts in comparison to the expected number of days. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention.
Outcome measures
| Measure |
SmartMoms-Clinic
n=18 Participants
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 Participants
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Percentage of Days With Intervention Adherence
|
60.8 percentage of days
Standard Deviation 6.4
|
76.5 percentage of days
Standard Deviation 4.5
|
—
|
POST_HOC outcome
Timeframe: Approximately 6 months (from 1st trimester until delivery)Clinic costs included interventionist time for training, session preparation, participant contacts, routine staff meetings, and scale and pedometer cost. Outcome measure only assessed in SmartMoms-Clinic and SmartMoms-Phone groups because the Physician Directed group did not receive any intervention. The US dollar cost was standard across each participant in each group so there is $0 standard deviation.
Outcome measures
| Measure |
SmartMoms-Clinic
n=18 Participants
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 Participants
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Intervention Cost for Clinic
|
419 US dollars
Standard Deviation 0.0
|
215 US dollars
Standard Deviation 0.0
|
—
|
Adverse Events
SmartMoms-Clinic
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
SmartMoms-Phone
Serious events: 1 serious events
Other events: 15 other events
Deaths: 0 deaths
Physician Directed
Serious events: 5 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SmartMoms-Clinic
n=18 participants at risk
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 participants at risk
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
n=17 participants at risk
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Miscarriage/pregnancy loss
|
0.00%
0/18 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/19 • Approximately 6 months (10-13 weeks gestation to delivery)
|
23.5%
4/17 • Number of events 4 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Renal and urinary disorders
Kidney stones requiring hospitalization
|
0.00%
0/18 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/19 • Approximately 6 months (10-13 weeks gestation to delivery)
|
5.9%
1/17 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Gastrointestinal disorders
Dehydration due to Crohn's disease requiring hospitalization
|
0.00%
0/18 • Approximately 6 months (10-13 weeks gestation to delivery)
|
5.3%
1/19 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/17 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Infections and infestations
Pneumonia requiring hospitalization
|
5.6%
1/18 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/19 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/17 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Pregnancy, puerperium and perinatal conditions
Severe pre-eclampsia requiring hospitalization
|
5.6%
1/18 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/19 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/17 • Approximately 6 months (10-13 weeks gestation to delivery)
|
Other adverse events
| Measure |
SmartMoms-Clinic
n=18 participants at risk
If picked for this group, you will attend study meetings with a weight management counselor. During the second trimester study meetings occur 4 times per month. During the third trimester you will attend study meetings 2 times per month. These meetings will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
SmartMoms-Phone
n=19 participants at risk
If picked for this group, you will have two individual sessions with a weight management counselor. At the first session, you will receive a scale and other technology to help manage your weight during pregnancy. Each week you will receive information from a weight management counselor via a Smartphone (you can use your own Smartphone or one will be provided to you). The information will cover topics to help manage your weight during pregnancy. We will ask you to measure your body weight (using a scale we will provide) as well as monitor your food intake and exercise habits with the Smartphone.
SmartMoms: This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
|
Physician Directed
n=17 participants at risk
If picked for this group, you will receive weight management advice from your physician's office.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/18 • Approximately 6 months (10-13 weeks gestation to delivery)
|
5.3%
1/19 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
11.8%
2/17 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Blood and lymphatic system disorders
Anemia
|
16.7%
3/18 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
21.1%
4/19 • Number of events 4 • Approximately 6 months (10-13 weeks gestation to delivery)
|
5.9%
1/17 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.1%
2/18 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
31.6%
6/19 • Number of events 7 • Approximately 6 months (10-13 weeks gestation to delivery)
|
11.8%
2/17 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Respiratory, thoracic and mediastinal disorders
Cold/sinus congestion
|
38.9%
7/18 • Number of events 9 • Approximately 6 months (10-13 weeks gestation to delivery)
|
15.8%
3/19 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
17.6%
3/17 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/18 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/19 • Approximately 6 months (10-13 weeks gestation to delivery)
|
11.8%
2/17 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Vascular disorders
Dizziness
|
11.1%
2/18 • Number of events 2 • Approximately 6 months (10-13 weeks gestation to delivery)
|
0.00%
0/19 • Approximately 6 months (10-13 weeks gestation to delivery)
|
11.8%
2/17 • Number of events 2 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Nervous system disorders
Headache
|
16.7%
3/18 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
26.3%
5/19 • Number of events 5 • Approximately 6 months (10-13 weeks gestation to delivery)
|
11.8%
2/17 • Number of events 2 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Gastrointestinal disorders
Heartburn
|
16.7%
3/18 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
36.8%
7/19 • Number of events 7 • Approximately 6 months (10-13 weeks gestation to delivery)
|
29.4%
5/17 • Number of events 5 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Blood and lymphatic system disorders
Low vitamin D
|
5.6%
1/18 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
15.8%
3/19 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
5.9%
1/17 • Number of events 1 • Approximately 6 months (10-13 weeks gestation to delivery)
|
|
Gastrointestinal disorders
Nausea/vomiting
|
16.7%
3/18 • Number of events 3 • Approximately 6 months (10-13 weeks gestation to delivery)
|
36.8%
7/19 • Number of events 10 • Approximately 6 months (10-13 weeks gestation to delivery)
|
35.3%
6/17 • Number of events 10 • Approximately 6 months (10-13 weeks gestation to delivery)
|
Additional Information
Dr. Leanne M. Redman
Pennington Biomedical Research Center
Phone: 2257630947
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place