Obesity
Conditions
Keywords
obesity, prevention, children
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.
Interventions
BEHAVIORALParents 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.
BEHAVIORALIncredible 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.
Sponsors
Michigan State University
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
1150 assessed for eligibility
Pre-assignment details
417 declined to enroll; 36 ineligible
Participants by arm
| Arm | Count |
|---|---|
| Usual Head Start Exposure Children will attend their usual Head Start classroom and receive the usual educational interventions provided in that classroom. | 218 |
| 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 | 224 |
| 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 | 255 |
| Total | 697 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 21 | 18 |
| Overall Study | no longer eligible | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 2 |
Baseline characteristics
| Characteristic | Usual Head Start Exposure | Parents of Preschoolers Series (POPS) | POPS + Incredible Years Series (IYS) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 218 Participants | 224 Participants | 255 Participants | 697 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.12 years STANDARD_DEVIATION 0.53 | 4.10 years STANDARD_DEVIATION 0.52 | 4.12 years STANDARD_DEVIATION 0.52 | 4.10 years STANDARD_DEVIATION 0.5 |
| Body Mass Index Z-score (BMI z-score) | 0.57 z-score STANDARD_DEVIATION 1.03 | 0.62 z-score STANDARD_DEVIATION 1.2 | 0.64 z-score STANDARD_DEVIATION 1.28 | 0.61 z-score STANDARD_DEVIATION 1.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 31 Participants | 25 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants | 192 Participants | 227 Participants | 608 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 56 Participants | 93 Participants | 70 Participants | 219 Participants |
| Race (NIH/OMB) More than one race | 27 Participants | 25 Participants | 19 Participants | 71 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 6 Participants | 7 Participants | 18 Participants |
| Race (NIH/OMB) White | 129 Participants | 99 Participants | 159 Participants | 387 Participants |
| Region of Enrollment United States | 218 participants | 224 participants | 255 participants | 697 participants |
| Sex: Female, Male Female | 117 Participants | 110 Participants | 131 Participants | 358 Participants |
| Sex: Female, Male Male | 101 Participants | 114 Participants | 124 Participants | 339 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 218 | 0 / 224 | 0 / 255 |
| other Total, other adverse events | 0 / 218 | 0 / 224 | 0 / 255 |
| serious Total, serious adverse events | 0 / 218 | 0 / 224 | 0 / 255 |
Outcome results
Primary
Change in Body Mass Index Z-score
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Head Start Exposure | Change in Body Mass Index Z-score | -0.01 Z-Score | Standard Error 0.03 |
| Parents of Preschoolers Series (POPS) | Change in Body Mass Index Z-score | 0.00 Z-Score | Standard Error 0.03 |
| POPS + Incredible Years Series (IYS) | Change in Body Mass Index Z-score | -0.04 Z-Score | Standard Error 0.03 |
Secondary
Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Head Start Exposure | 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 |
| Parents of Preschoolers Series (POPS) | Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale | 1.28 change in t-score from pre to post | Standard Error 0.56 |
| POPS + Incredible Years Series (IYS) | Change in Teacher-reported Self-regulation as Measured by the General Adaptation T-score From the Social Competence and Behavior Evaluation Scale | 3.92 change in t-score from pre to post | Standard Error 0.5 |