Trial Outcomes & Findings for Prevention of Postpartum Weight Retention in Low Income WIC Women (NCT NCT01408147)
NCT ID: NCT01408147
Last Updated: 2020-09-16
Results Overview
Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
371 participants
Primary outcome timeframe
12 months
Results posted on
2020-09-16
Participant Flow
12 WIC Clinics Recruited; 371 participants total across all clinics
Unit of analysis: 12
Participant milestones
| Measure |
Treatment Group
This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
|
Standard WIC Care
The control group will received Standard Care as provided through WIC.
|
|---|---|---|
|
Overall Study
STARTED
|
174 5
|
197 6
|
|
Overall Study
COMPLETED
|
174 5
|
196 6
|
|
Overall Study
NOT COMPLETED
|
0 0
|
1 0
|
Reasons for withdrawal
| Measure |
Treatment Group
This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
|
Standard WIC Care
The control group will received Standard Care as provided through WIC.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Prevention of Postpartum Weight Retention in Low Income WIC Women
Baseline characteristics by cohort
| Measure |
Treatment Group
n=174 Participants
This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
|
Standard WIC Care
n=197 Participants
The control group will received Standard Care as provided through WIC.
|
Total
n=371 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.5 years
STANDARD_DEVIATION 5.2 • n=93 Participants
|
28.6 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
28.1 years
STANDARD_DEVIATION 5.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
174 Participants
n=93 Participants
|
197 Participants
n=4 Participants
|
371 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
146 Participants
n=93 Participants
|
157 Participants
n=4 Participants
|
303 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
68 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
174 Participants
n=93 Participants
|
196 Participants
n=4 Participants
|
370 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: This cluster randomized trial included 11 clinics. Participant numbers reflect number of people randomized within the clinics.
Women randomized to the weight loss group will be assessed over time at study entry, 6 months, and 12 months. The primary outcome is change from entry to the endpoint at 12 months.
Outcome measures
| Measure |
Treatment Group
n=174 Participants
This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
|
Standard WIC Care
n=196 Participants
The control group will received Standard Care as provided through WIC.
|
|---|---|---|
|
Weight
|
-3.2 kg
Interval -4.1 to -2.4
|
-0.9 kg
Interval -1.7 to -0.1
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: 12 clusters were randomized. Sample size above reflect total number of participants in each group.
Calorie intake was measured over time at study entry, 6 and 12 months. The primary outcome is change from entry to 12 months.
Outcome measures
| Measure |
Treatment Group
n=170 Participants
This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
|
Standard WIC Care
n=191 Participants
The control group will received Standard Care as provided through WIC.
|
|---|---|---|
|
Calorie Intake
|
-298 kcal/day
Interval -423.0 to -174.0
|
-144 kcal/day
Interval -257.0 to -32.0
|
Adverse Events
Treatment Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Standard WIC Care
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Group
n=174 participants at risk
This group will be allowed access to an online weight loss program. The program is designed to help low income women lose weight through lifestyle intervention.
Online postpartum weight control: The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
|
Standard WIC Care
n=196 participants at risk
The control group will received Standard Care as provided through WIC.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Self-reported injury from physical activity
|
9.2%
16/174 • Number of events 16
|
7.7%
15/196 • Number of events 15
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place