Trial Outcomes & Findings for Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers (NCT NCT01398358)
NCT ID: NCT01398358
Last Updated: 2018-02-05
Results Overview
Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
697 participants
Primary outcome timeframe
9 months
Results posted on
2018-02-05
Participant Flow
1150 assessed for eligibility
417 declined to enroll; 36 ineligible
Participant milestones
| Measure |
Usual Head Start Exposure
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
|
Parents of Preschoolers Series (POPS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.
The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal
|
POPS + Incredible Years Series (IYS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an
|
|---|---|---|---|
|
Overall Study
STARTED
|
218
|
224
|
255
|
|
Overall Study
COMPLETED
|
203
|
201
|
234
|
|
Overall Study
NOT COMPLETED
|
15
|
23
|
21
|
Reasons for withdrawal
| Measure |
Usual Head Start Exposure
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
|
Parents of Preschoolers Series (POPS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.
The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal
|
POPS + Incredible Years Series (IYS)
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
21
|
18
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
2
|
|
Overall Study
no longer eligible
|
1
|
0
|
1
|
Baseline Characteristics
Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
Baseline characteristics by cohort
| Measure |
Usual Head Start Exposure
n=218 Participants
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
|
Parents of Preschoolers Series (POPS)
n=224 Participants
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.
The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal
|
POPS + Incredible Years Series (IYS)
n=255 Participants
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an
|
Total
n=697 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
218 Participants
n=5 Participants
|
224 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
697 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
4.12 years
STANDARD_DEVIATION 0.53 • n=5 Participants
|
4.10 years
STANDARD_DEVIATION 0.52 • n=7 Participants
|
4.12 years
STANDARD_DEVIATION 0.52 • n=5 Participants
|
4.10 years
STANDARD_DEVIATION 0.50 • n=4 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
358 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
339 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
84 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=5 Participants
|
192 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
608 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 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
|
56 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
219 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
129 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
159 Participants
n=5 Participants
|
387 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
27 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
71 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
218 participants
n=5 Participants
|
224 participants
n=7 Participants
|
255 participants
n=5 Participants
|
697 participants
n=4 Participants
|
|
Body Mass Index Z-score (BMI z-score)
|
0.57 z-score
STANDARD_DEVIATION 1.03 • n=5 Participants
|
0.62 z-score
STANDARD_DEVIATION 1.20 • n=7 Participants
|
0.64 z-score
STANDARD_DEVIATION 1.28 • n=5 Participants
|
0.61 z-score
STANDARD_DEVIATION 1.17 • n=4 Participants
|
PRIMARY outcome
Timeframe: 9 monthsPopulation: Seven of the 697 were excluded from analysis because they were missing both pre- and post- intervention BMI z-score. It was possible for a child to be included in the final analysis population even if they had not completed the follow-up portion of the study because the mixed model statistical method used could include their pre-intervention data.
Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period
Outcome measures
| Measure |
Usual Head Start Exposure
n=216 Participants
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
|
Parents of Preschoolers Series (POPS)
n=221 Participants
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.
The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal
|
POPS + Incredible Years Series (IYS)
n=253 Participants
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an
|
|---|---|---|---|
|
Change in Body Mass Index Z-score
|
-0.01 Z-Score
Standard Error 0.03
|
0.00 Z-Score
Standard Error 0.03
|
-0.04 Z-Score
Standard Error 0.03
|
SECONDARY outcome
Timeframe: 9 monthsTo assess self-regulation, teachers completed a modified 60-item version of the Social Competence and Behavior Evaluation (SCBE) scale.The SCBE assesses emotional and behavioral regulation difficulties typically seen in the preschool setting. It includes both positive (competence) and negative (emotional or behavioral problems) items, including internalizing (ie, anxious, sad) and externalizing (ie, oppositional) behaviors, both of which are indicators of poor behavioral self-regulation. The General Adaptation T-score assesses child overall emotional and behavioral self-regulation in the classroom setting. It is calculated by taking the mean of all 60 items for the SCBE questionnaire (with reverse scoring for questions capturing problem behavior) and then determining the corresponding t-score based on published tables. Higher scores indicate better self-regulation. The range for General Adaptation T-score is 30-70.
Outcome measures
| Measure |
Usual Head Start Exposure
n=216 Participants
Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
|
Parents of Preschoolers Series (POPS)
n=221 Participants
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.
The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal
|
POPS + Incredible Years Series (IYS)
n=253 Participants
Children attend Head Start preschool. Within the classroom, they receive a series of lessons about nutrition and obesity prevention delivered by an Extension Educator in collaboration with the classroom teacher. Parents are invited to attend a series of classes about nutrition and obesity prevention. In the classroom, children also receive a series of lessons about emotional and behavioral self-regulation delivered by a trained mental health specialist. The parents also are invited to classes about child behavioral and emotional self-regulation delivered by a mental health specialist.
Parents of Preschoolers Series: The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge an
|
|---|---|---|---|
|
Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale
|
0.93 change in t-score from pre to post
Standard Error 0.55
|
1.28 change in t-score from pre to post
Standard Error 0.56
|
3.92 change in t-score from pre to post
Standard Error 0.50
|
Adverse Events
Usual Head Start Exposure
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parents of Preschoolers Series (POPS)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
POPS + Incredible Years Series (IYS)
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