Childhood Obesity
Conditions
Keywords
obesity, youth, garden, diet, produce
Brief summary
The objective of this study is to implement and test the efficacy of the "Summer Harvest Adventure," a comprehensive garden-based behavioral, social, and environmental intervention for children (ages 8-11 years) residing in low-resource communities.
Detailed description
The investigators will conduct a 2-arm randomized controlled trial designed to determine the efficacy of a multifaceted obesity prevention and lifestyle intervention in low-resource children and parent/adult caregiver (PAC) called "Summer Harvest Adventure." A total of 240 children (ages 8-11 years) will be randomized to the garden-based intervention (SHA) or an enhanced control group (MSP). Summer Harvest Adventure includes: 1) remote and group coaching using a focused motivational interviewing approach; 2) weekly fruit, vegetable, and herb harvesting to increase summer food access; and 3) group education for children and their families in a social setting. Assessments for both groups will be collected at orientation held one week prior to the intervention (week 0), and immediately following the completion of the intervention (week 10) by trained personnel that are blinded to participants' treatment arm assignment.
Interventions
BEHAVIORALSummer Harvest Adventure
Biobehavioral intervention focusing on nutrition and lifestyle behaviors.
BEHAVIORALMy Summer Plate (MSP)
My Summer Plate (MSP)
Sponsors
Ohio State University
Nationwide Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Clinical assessments for both groups (intervention and control) will be conducted by trained personnel that are blinded to participants' treatment arm assignment.
Intervention model description
Phase 2 prospective randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
Yes
Inclusion criteria
* Children 8-11 years of age (as of June 1) from assenting and consenting families * English-speaking families that agree to participate; 3) residents of SNAP-eligible communities in Franklin County, Ohio.
Exclusion criteria
* Inability to functionally participate in harvesting; accommodations can be implemented in the future for children with special needs * Communication difficulties (e.g. severe developmental delay) * Lack of transportation to weekly classes or harvesting activities * Non-English speakers; because coaching and classroom-based education are all conducted in English, we will of necessity restrict to English-speakers only during this phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Produce Intake | Baseline and 10 weeks | Change in fruit and vegetable intake as assessed by dermal skin carotenoid scores using Raman Spectroscopy (Pharmanex NuSkin Biophotonic Scanner model S3). Dermal skin carotenoid scores range 10,000-85,000, with higher scores indicating higher skin carotenoid levels. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight | Baseline and 10 weeks | Change in weight will be recorded with a precision of 0.1 kilogram (kg) |
| Family Engagement | Baseline and 10 weeks | Change in family engagement as assessed by the Expressed Emotion Adjective Checklist. The Expressed Emotion Adjective Checklist (EEAC) is a self-reported measure of expressed emotions. Twenty items are summed to a total score (range 20-140); higher scores indicate more positive expressed emotion (better outcome). |
| Blood Pressure | Baseline and 10 weeks | Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain blood pressure readings |
| Height | Baseline and 10 weeks | Change in standing height will be measured to the nearest 1 mm using a standardized fixed stadiometer with a vertical backboard and moveable headboard |
| BMI Percentile | Baseline and 10 weeks | BMI will be calculated using weight (kg) divided by the square of height (m). BMI-for-age percentile growth charts will be used to measure the size and growth patterns of children in the study |
Countries
United States
Participant flow
Recruitment details
COVID-19 required shut down of study in Years 2 & 3
Pre-assignment details
SNAP-eligible adolescent between the ages of 8-11 + caregiver. Data was collected only for the children enrolled, thus enrollment numbers represent unique participants (i.e., children enrolled in study).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 192 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 89 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 100 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 92 Participants |
| Region of Enrollment United States | 96 Participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 96 |
| other Total, other adverse events | 0 / 96 | 0 / 96 |
| serious Total, serious adverse events | 0 / 96 | 0 / 96 |
Outcome results
None listed