Pediatric Obesity
Conditions
Keywords
physical activity (exercise), sedentary activity, sleep, fruit, vegetable
Brief summary
This clinical trial tests the effectiveness of a Healthy Parents and Children Enhancement (H-PACE) program for improving lifestyle behaviors among children. Proper nutrition and physical activity (PA) are essential parts of overall health. Together, they can decrease the risk of developing obesity as well as related diseases such as diabetes, heart disease, stroke, and several types of cancer. To address the prevalence of obesity and related diseases, programs focusing on increasing opportunities for active living and healthy eating are necessary. Multi-component school-based obesity prevention programs have demonstrated increases in PA and improvement in dietary habits; however, most afterschool programs are short term; evidence is needed to confirm long-term effects. Moreover, programs that involve parents have shown to be more successful in helping children choose healthier behaviors. Unfortunately, due to technological advancement, opportunities for children to be active in schools have become more limited in modern society. H-PACE program is based on the national childhood obesity prevention campaign designed to help families, schools, communities, and physicians to raise awareness of nutritional and PA daily guidelines. The H-PACE will encourage daily lifestyle behaviors (five or more servings of fruits and vegetables, two hours or less of recreational screen time, one hour of PA, zero sugary drinks, ten hours of sleep) that impact childhood obesity. This trial is being done to determine whether participating in the H-PACE program may help improve lifestyle behaviors among children.
Detailed description
OUTLINE: Children attend the H-PACE program comprising educational lessons over 30 minutes, PA over 30 minutes, and healthy snacks twice a week (BIW) for 12 weeks. The educational component includes 30-minute lessons on PA, fruits and vegetables, and sleep, followed by fun and entertaining games and activities. The PA component (30-minutes) comprises a variety of enjoyable activities including warm-up, main activities (e.g., walk/run/jog and aerobic fun games), and cool-down. The snack component introduces children to tasty and healthy foods and teaches children the skills to enable them to select and prepare healthy snack foods at school and at home. Snack education lessons emphasize the benefits of fruit and vegetable intake, and include a discussion of food composition (e.g., fat content, sugar, sodium). Children prepare healthy snack foods at home with parents once a week (QW) by taking home fruit and vegetable boxes with recipes for family-based engaging activities. Children also wear an accelerometer to monitor activity for 7 days at baseline and during week 11-12. Parents may participate in an optional virtual peer support group on study.
Interventions
Participate in the H-PACE program
Wear an accelerometer
Ancillary studies
Parents may participate in an optional virtual peer support group
Sponsors
Study design
Eligibility
Inclusion criteria
* Children in 3rd - 5th grade, 8-11 years of age, attending the afterschool program at the selected elementary schools. * Parents/Guardians of the eligible child, who are ≥ 18 years old. * Fluency in English or Spanish.
Exclusion criteria
* Children who are not in 3rd - 5th grade. * Children not attending the afterschool program at the selected elementary schools. * Parents/Guardians of the eligible child, who are \< 18 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Children Who Attended More Than 75% of Program Sessions (Feasibility) | Up to week 14 | Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric. |
| Percentage of Children Who Completed More Than 80% of Assessment Activities (Feasibility) | Up to week 14 | Will be assessed using descriptive statistics. Will be considered a success from a feasibility standpoint if \> 75% of participants meet the metric. |
Countries
United States
Contacts
Fred Hutch/University of Washington Cancer Consortium
New Mexico State University
Participant flow
Recruitment details
Recruitment occurred in 2 elementary schools in the Central Valley of WA state and 2 elementary schools in Las Cruces, NM. The New Mexico research team leveraged existing relationship with after-school program to identify schools to participate in this study. WA research team worked with district superintendent to identify 2 schools. Recruitment flyers were disseminated at each school, and research staff attended parent meetings to present the study and answer questions.
Pre-assignment details
N/A; Single arm intervention to test feasibility. Prior to start of intervention 22 parent-child dyads in New Mexico and 39 parent-child dyads in Central Washington were recruited and completed informed consent/assent, for a total of 122 participants. Of those, 121 (60 parents and 61 children) completed a baseline survey.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Kids | 10 Years STANDARD_DEVIATION 0.96 |
| Age, Continuous Parents | 39 Years STANDARD_DEVIATION 9.1 |
| Ethnicity (NIH/OMB) Kids Hispanic or Latino | 57 Participants |
| Ethnicity (NIH/OMB) Kids Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Kids Unknown or Not Reported | 1 Participants |
| Ethnicity (NIH/OMB) Parents Hispanic or Latino | 55 Participants |
| Ethnicity (NIH/OMB) Parents Not Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Parents Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Kids American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Kids Asian | 0 Participants |
| Race (NIH/OMB) Kids Black or African American | 4 Participants |
| Race (NIH/OMB) Kids More than one race | 1 Participants |
| Race (NIH/OMB) Kids Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Kids Unknown or Not Reported | 4 Participants |
| Race (NIH/OMB) Kids White | 51 Participants |
| Race (NIH/OMB) Parents American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Parents Asian | 0 Participants |
| Race (NIH/OMB) Parents Black or African American | 4 Participants |
| Race (NIH/OMB) Parents More than one race | 0 Participants |
| Race (NIH/OMB) Parents Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Parents Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) Parents White | 52 Participants |
| Sex: Female, Male Kids Female | 35 Participants |
| Sex: Female, Male Kids Male | 25 Participants |
| Sex: Female, Male Parents Female | 51 Participants |
| Sex: Female, Male Parents Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |