Trial Outcomes & Findings for Starting Pediatric Obesity Prevention in Pregnancy (NCT NCT01279109)
NCT ID: NCT01279109
Last Updated: 2021-11-18
Results Overview
Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy. (Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
147 participants
Primary outcome timeframe
Duration of pregnancy
Results posted on
2021-11-18
Participant Flow
147 were consented; 12 withdrew consent before randomization (reason: too much time to commit); 135 were randomized
Participant milestones
| Measure |
Social Network Building Intervention
Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy
|
Home Visit
Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
67
|
|
Overall Study
COMPLETED
|
55
|
55
|
|
Overall Study
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Starting Pediatric Obesity Prevention in Pregnancy
Baseline characteristics by cohort
| Measure |
Social Network Building Intervention
n=68 Participants
Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy
|
Home Visit
n=67 Participants
Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
26.1 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 5.9 • n=7 Participants
|
26.2 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Latina
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African-American
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not self-identified
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
67 participants
n=7 Participants
|
135 participants
n=5 Participants
|
|
Language preference
English
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Language preference
Spanish
|
41 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Language preference
English AND Spanish
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Baseline Body Mass Index Category
Underweight
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Baseline Body Mass Index Category
Normal weight
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
53 participants
n=5 Participants
|
|
Baseline Body Mass Index Category
Overweight
|
23 participants
n=5 Participants
|
23 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
Baseline Body Mass Index Category
Obese
|
19 participants
n=5 Participants
|
17 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Duration of pregnancyPopulation: Analysis is presented within baseline BMI categories and overall. The Overall Number of Participants Analyzed represents those study participants for whom medical records could be abstracted in the trial (87/135).
Total weight gain during pregnancy extracted from medical record, relative to the 2009 Institute of Medicine (IOM) Weight Gain Recommendations for Pregnancy. (Reference: Institute of Medicine (US). Weight gain during pregnancy: reexamining the guidelines. Washington, DC. National Academies Press; 2009. 2009 National Academy of Sciences.)
Outcome measures
| Measure |
Social Network Building Intervention
n=44 Participants
Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy
|
Home Visit
n=43 Participants
Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
|
|---|---|---|
|
Gestational Weight Gain
Underweight (pre-pregnancy BMI) · Under IOM recommendations
|
0 Participants
|
0 Participants
|
|
Gestational Weight Gain
Underweight (pre-pregnancy BMI) · Within IOM recommendations
|
0 Participants
|
0 Participants
|
|
Gestational Weight Gain
Underweight (pre-pregnancy BMI) · Over IOM recommendations
|
0 Participants
|
0 Participants
|
|
Gestational Weight Gain
Normal weight (pre-pregnancy BMI) · Under IOM recommendations
|
8 Participants
|
6 Participants
|
|
Gestational Weight Gain
Normal weight (pre-pregnancy BMI) · Within IOM recommendations
|
6 Participants
|
3 Participants
|
|
Gestational Weight Gain
Normal weight (pre-pregnancy BMI) · Over IOM recommendations
|
1 Participants
|
8 Participants
|
|
Gestational Weight Gain
Overweight (pre-pregnancy BMI) · Under IOM recommendations
|
3 Participants
|
6 Participants
|
|
Gestational Weight Gain
Overweight (pre-pregnancy BMI) · Within IOM recommendations
|
7 Participants
|
3 Participants
|
|
Gestational Weight Gain
Overweight (pre-pregnancy BMI) · Over IOM recommendations
|
4 Participants
|
6 Participants
|
|
Gestational Weight Gain
Obese (pre-pregnancy BMI) · Under IOM recommendations
|
4 Participants
|
1 Participants
|
|
Gestational Weight Gain
Obese (pre-pregnancy BMI) · Within IOM recommendations
|
4 Participants
|
5 Participants
|
|
Gestational Weight Gain
Obese (pre-pregnancy BMI) · Over IOM recommendations
|
7 Participants
|
5 Participants
|
|
Gestational Weight Gain
All (pre-pregnancy BMI) · Under IOM recommendations
|
15 Participants
|
13 Participants
|
|
Gestational Weight Gain
All (pre-pregnancy BMI) · Within IOM recommendations
|
17 Participants
|
11 Participants
|
|
Gestational Weight Gain
All (pre-pregnancy BMI) · Over IOM recommendations
|
12 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 2 times over 12 weeks (Week 6, Week 12)Population: 59 participants in the intervention group completed at least one wave of social network data collection. Control group participants did not have protocol-specified group sessions to evaluate.
Number of discussion partners within the intervention group. Participants were asked to identify by name any program participants with whom they had spoken about their pregnancy or pregnancy-related health behaviors.
Outcome measures
| Measure |
Social Network Building Intervention
n=59 Participants
Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members
Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy
|
Home Visit
Home visits focused on preventable infant injuries
Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention
|
|---|---|---|
|
Social Network
|
3.56 number of discussion partner ties
Standard Deviation 2.11
|
—
|
Adverse Events
Social Network Building Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Home Visit
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