Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers

• Sponsor: University of Michigan (Other)
• Overall Status: Completed
• CT.gov ID: NCT01398358
• Collaborator: Michigan State University (Other)
• Enrollment: 697
• Location: 1
• Arms: 3
• Duration (Months): 50
• Patients Per Site Per Month: 13.9

Study Details

Study Description

Brief Summary

The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Behavioral: Parents of Preschoolers Series; Behavioral: Incredible Years Series	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 697 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Enhancing Self Regulation as a Strategy for Obesity Prevention in Head Start Preschoolers
• Study Start Date: Mar 1, 2011
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Head Start Exposure Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.
Experimental: 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.	Behavioral: 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 setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home.
Experimental: 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.	Behavioral: 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 setting. "Family Links" and "Parent Pages" are sent home to reinforce content from school to home.; Behavioral: Incredible Years Series; The Parent component (BASIC) is a group-based program (12-14 weeks, 2 hours/week) focused on enhancing parenting skills such as using effective praise, incentives, and limit-setting, and handling misbehavior. Parents complete homework activities that will be reviewed in group sessions and receive follow-up reinforcement phone calls. For the Child component ("Dinosaur School"), 60, 15-20 minute lessons are delivered during "Circle Time" in Head Start classrooms followed by small group activities. The curriculum focuses on teaching self-regulation skills, problem-solving strategies, and prosocial behaviors. Teachers are trained in classroom management strategies.

Outcome Measures

Primary Outcome Measures

1. Change in Body Mass Index Z-score [9 months]

   Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period

Secondary Outcome Measures

1. Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale [9 months]

   To 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 2 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• child is enrolled in Head Start

Exclusion Criteria:

• Significant developmental disabilities that would preclude participation

• Child is a foster child

• Parent is non-English speaking

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Michigan	Ann Arbor	Michigan	United States	48109-5406

Sponsors and Collaborators

• University of Michigan
• Michigan State University

Investigators

• Principal Investigator: Julie Lumeng, MD, University of Michigan

Study Documents (Full-Text)

None provided.

More Information

Publications

• Miller AL, Horodynski MA, Herb HE, Peterson KE, Contreras D, Kaciroti N, Staples-Watson J, Lumeng JC. Enhancing self-regulation as a strategy for obesity prevention in Head Start preschoolers: the growing healthy study. BMC Public Health. 2012 Nov 30;12:1040. doi: 10.1186/1471-2458-12-1040.

• Responsible Party: Julie Lumeng, Associate Professor of Pediatrics, University of Michigan
• ClinicalTrials.gov Identifier: NCT01398358
• Other Study ID Numbers: 2010-04785
• First Posted: Jul 20, 2011
• Last Update Posted: Feb 5, 2018
• Last Verified: Jul 1, 2017

• Keywords provided by Julie Lumeng, Associate Professor of Pediatrics, University of Michigan: obesity; prevention; children
• Additional relevant MeSH terms: Obesity

Study Results

Participant Flow

Recruitment Details	1150 assessed for eligibility
Pre-assignment Detail	417 declined to enroll; 36 ineligible

Arm/Group Title	Usual Head Start Exposure	Parents of Preschoolers Series (POPS)	POPS + Incredible Years Series (IYS)
Arm/Group Description	Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.	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	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
Period Title: Overall Study
STARTED	218	224	255
COMPLETED	203	201	234
NOT COMPLETED	15	23	21

Baseline Characteristics

Arm/Group Title	Usual Head Start Exposure	Parents of Preschoolers Series (POPS)	POPS + Incredible Years Series (IYS)	Total
Arm/Group Description	Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.	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	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 of all reporting groups
Overall Participants	218	224	255	697
Age (Count of Participants)
<=18 years	218 100%	224 100%	255 100%	697 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.12 (0.53)	4.10 (0.52)	4.12 (0.52)	4.10 (0.50)
Sex: Female, Male (Count of Participants)
Female	117 53.7%	110 49.1%	131 51.4%	358 51.4%
Male	101 46.3%	114 50.9%	124 48.6%	339 48.6%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	28 12.8%	31 13.8%	25 9.8%	84 12.1%
Not Hispanic or Latino	189 86.7%	192 85.7%	227 89%	608 87.2%
Unknown or Not Reported	1 0.5%	1 0.4%	3 1.2%	5 0.7%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.5%	1 0.4%	0 0%	2 0.3%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	56 25.7%	93 41.5%	70 27.5%	219 31.4%
White	129 59.2%	99 44.2%	159 62.4%	387 55.5%
More than one race	27 12.4%	25 11.2%	19 7.5%	71 10.2%
Unknown or Not Reported	5 2.3%	6 2.7%	7 2.7%	18 2.6%
Region of Enrollment (participants) [Number]
United States	218 100%	224 100%	255 100%	697 100%
Body Mass Index Z-score (BMI z-score) (z-score) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [z-score]	0.57 (1.03)	0.62 (1.20)	0.64 (1.28)	0.61 (1.17)

Outcome Measures

1. Primary Outcome

Title	Change in Body Mass Index Z-score
Description	Child BMI z-score was calculated from measure height and weight at enrollment and at the end of the study period
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Usual Head Start Exposure	Parents of Preschoolers Series (POPS)	POPS + Incredible Years Series (IYS)
Arm/Group Description	Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.	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	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
Measure Participants	216	221	253
Mean (Standard Error) [Z-Score]	-0.01 (0.03)	0.00 (0.03)	-0.04 (0.03)

2. Secondary Outcome

Title	Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale
Description	To 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.
Time Frame	9 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Usual Head Start Exposure	Parents of Preschoolers Series (POPS)	POPS + Incredible Years Series (IYS)
Arm/Group Description	Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.	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	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
Measure Participants	216	221	253
Mean (Standard Error) [change in t-score from pre to post]	0.93 (0.55)	1.28 (0.56)	3.92 (0.50)

Adverse Events

Time Frame	9 months
Arm/Group Title	Usual Head Start Exposure		Parents of Preschoolers Series (POPS)		POPS + Incredible Years Series (IYS)
Arm/Group Description	Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom.		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		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
All Cause Mortality
	Usual Head Start Exposure		Parents of Preschoolers Series (POPS)		POPS + Incredible Years Series (IYS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/218 (0%)		0/224 (0%)		0/255 (0%)
Serious Adverse Events
	Usual Head Start Exposure		Parents of Preschoolers Series (POPS)		POPS + Incredible Years Series (IYS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/218 (0%)		0/224 (0%)		0/255 (0%)
Other (Not Including Serious) Adverse Events
	Usual Head Start Exposure		Parents of Preschoolers Series (POPS)		POPS + Incredible Years Series (IYS)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/218 (0%)		0/224 (0%)		0/255 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.