Trial Outcomes & Findings for A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women (NCT NCT01751230)
NCT ID: NCT01751230
Last Updated: 2021-08-24
Results Overview
The primary outcome measure is weight change after the 16 week intervention.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
Baseline and 16 weeks
Results posted on
2021-08-24
Participant Flow
Potential participants will be recruited via Institutional Review Board (IRB) approved posters and flyers displayed in the WIC office and advertisements posted on the PBRC website (http://www.pbrc.edu/clinicaltrials).
Participant milestones
| Measure |
WIC E-Moms
Participants enrolled in the WIC E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
|
WIC Moms
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
19
|
16
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Personalized Telehealth Intervention for Health and Weight Loss in Postpartum Women
Baseline characteristics by cohort
| Measure |
WIC E-Moms
n=19 Participants
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
|
WIC Moms
n=16 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
Total
n=35 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
27.2 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Preconception weight
|
80.7 kg
STANDARD_DEVIATION 9.1 • n=5 Participants
|
79.9 kg
STANDARD_DEVIATION 17.4 • n=7 Participants
|
80.4 kg
STANDARD_DEVIATION 14.2 • n=5 Participants
|
|
Gestational weight gain
|
14.3 kg
STANDARD_DEVIATION 9.2 • n=5 Participants
|
15.2 kg
STANDARD_DEVIATION 8 • n=7 Participants
|
14.7 kg
STANDARD_DEVIATION 8.6 • n=5 Participants
|
|
BMI
|
31.3 kg/m^2
STANDARD_DEVIATION 3.2 • n=5 Participants
|
32.7 kg/m^2
STANDARD_DEVIATION 2.8 • n=7 Participants
|
32.1 kg/m^2
STANDARD_DEVIATION 3.3 • n=5 Participants
|
|
Enrollment weight
|
83.8 kg
STANDARD_DEVIATION 13.5 • n=5 Participants
|
88.4 kg
STANDARD_DEVIATION 9.7 • n=7 Participants
|
85.9 kg
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Body fat
|
40.2 %
STANDARD_DEVIATION 4.7 • n=5 Participants
|
41.7 %
STANDARD_DEVIATION 3.8 • n=7 Participants
|
40.9 %
STANDARD_DEVIATION 4.3 • n=5 Participants
|
|
Systolic blood pressure
|
117.5 mmHg
STANDARD_DEVIATION 13.8 • n=5 Participants
|
116.7 mmHg
STANDARD_DEVIATION 12.6 • n=7 Participants
|
117.2 mmHg
STANDARD_DEVIATION 13.2 • n=5 Participants
|
|
Diastolic blood pressure
|
74.6 mmHg
STANDARD_DEVIATION 9.2 • n=5 Participants
|
73.9 mmHg
STANDARD_DEVIATION 10.1 • n=7 Participants
|
74.5 mmHg
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Parity
|
1.6 pregnancies
STANDARD_DEVIATION 1.0 • n=5 Participants
|
2 pregnancies
STANDARD_DEVIATION 1.3 • n=7 Participants
|
1.8 pregnancies
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Marital status
Married
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Marital status
Not married and living with significant other
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Marital status
Separated/divorced
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital status
Single
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Education
Some high school
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Education
High school diploma/General education development
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education
1-3 college
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Education
College degree
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Education
Postgraduate
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Breastfeed ever
No
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Breastfeed ever
Yes
|
15 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Current smoker
No
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Current smoker
Yes
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 16 weeksThe primary outcome measure is weight change after the 16 week intervention.
Outcome measures
| Measure |
WIC E-Moms
n=19 Participants
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
|
WIC Moms
n=16 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
High Adherers
Subgroup of E-Moms Intervention group meeting greater than 70% (5 or more days of engagement per week) of expected number of days for logging weights and recording steps.
|
WIC Moms
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
|---|---|---|---|---|
|
Body Weight Change
|
-0.1 kg
Standard Error 0.9
|
1.8 kg
Standard Error 0.9
|
—
|
—
|
POST_HOC outcome
Timeframe: Baseline and 16 weeksPopulation: All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
Changes in hip circumference from baseline (Week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms).
Outcome measures
| Measure |
WIC E-Moms
n=7 Participants
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
|
WIC Moms
n=7 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
High Adherers
n=5 Participants
Subgroup of E-Moms Intervention group meeting greater than 70% (5 or more days of engagement per week) of expected number of days for logging weights and recording steps.
|
WIC Moms
n=16 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
|---|---|---|---|---|
|
Changes in Hip Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers
|
2.8 cm
Standard Error 1.4
|
0.96 cm
Standard Error 1.44
|
-5.0 cm
Standard Error 1.7
|
0.62 cm
Standard Error 0.95
|
POST_HOC outcome
Timeframe: Baseline and 16 weeksPopulation: All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
Changes in waist circumference from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
Outcome measures
| Measure |
WIC E-Moms
n=7 Participants
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
|
WIC Moms
n=7 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
High Adherers
n=5 Participants
Subgroup of E-Moms Intervention group meeting greater than 70% (5 or more days of engagement per week) of expected number of days for logging weights and recording steps.
|
WIC Moms
n=16 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
|---|---|---|---|---|
|
Changes in Waist Circumference of WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers
|
2.6 cm
Standard Error 2.2
|
-2.5 cm
Standard Error 0.96
|
-4.1 cm
Standard Error 2.6
|
0.99 cm
Standard Error 1.48
|
POST_HOC outcome
Timeframe: Baseline and 16 weeksPopulation: All participants stratified by adherence to the E-Moms intervention and usual care (WIC Moms)
Changes in % body fat from baseline (week 0) stratified by adherence to the E-Moms intervention and usual care (WIC Moms).
Outcome measures
| Measure |
WIC E-Moms
n=7 Participants
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
|
WIC Moms
n=7 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
High Adherers
n=5 Participants
Subgroup of E-Moms Intervention group meeting greater than 70% (5 or more days of engagement per week) of expected number of days for logging weights and recording steps.
|
WIC Moms
n=16 Participants
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
|---|---|---|---|---|
|
Changes in % Body Fat in WIC Moms, WIC E-Moms Subgroups: High, Medium, and Low Adherers.
|
1.1 % body fat
Standard Error 0.9
|
0.9 % body fat
Standard Error 0.9
|
-2.5 % body fat
Standard Error 1.0
|
1.7 % body fat
Standard Error 0.6
|
Adverse Events
WIC E-Moms
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
WIC Moms
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
WIC E-Moms
n=19 participants at risk
Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
|
WIC Moms
n=16 participants at risk
Participants in WIC Moms will receive standardized advice and services for postpartum nutrition and weight management through their nominated WIC clinic. Participants in the control group will not receive a dietary prescription or personalized weight management services from the Pennington Biomedical study team.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cold
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
0.00%
0/16 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
|
Infections and infestations
Viral infection
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
6.2%
1/16 • Number of events 1 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
|
Gastrointestinal disorders
Nausea
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
0.00%
0/16 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
|
General disorders
Flu
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
0.00%
0/16 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
|
General disorders
Fatigue
|
5.3%
1/19 • Number of events 1 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
0.00%
0/16 • Adverse event data was collected over a year time span.
Participant's were questioned by study staff at each study visit for any new or outstanding adverse event details.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place