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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Summer Harvest Adventure (SHA) | Experimental | Remote nutrition counseling, weekly produce harvesting, group nutrition education |
|
| My Summer Plate (MSP) | Active Comparator | Nutrition education packet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Summer Harvest Adventure | Behavioral | Biobehavioral intervention focusing on nutrition and lifestyle behaviors. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Produce Intake | 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. | Baseline and 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Weight | Change in weight will be recorded with a precision of 0.1 kilogram (kg) | Baseline and 10 weeks |
| Family Engagement | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Loman B, Hill E, Bailey M, et al. A High-Fiber Diet Intervention Improves Diet Quality and Is Related to Blood Pressure and Bacteriome Composition in Caregiver-Child Dyads. Curr Dev Nutr. 2021;5(Suppl 2):1168. Published 2021 Jun 7. doi:10.1093/cdn/nzab054_023 | ||
| 40886942 | Result | Gao S, Chen L, Zhang H, Khalsa AS, Bailey MT, Loman BR, Spees CK, Zhu J. Comparing and optimizing protein extraction methods with different lysis buffers for the analyses of human fecal microbiome via metaproteomics approach. J Microbiol Methods. 2025 Oct;237:107244. doi: 10.1016/j.mimet.2025.107244. Epub 2025 Aug 29. | |
| 36981636 |
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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).
COVID-19 required shut down of study in Years 2 & 3
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| ID | Title | Description |
|---|---|---|
| FG000 | Summer Harvest Adventure (SHA) | Remote nutrition counseling, weekly produce harvesting, group nutrition education |
| FG001 | My Summer Plate (MSP) | Nutrition education packet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline characteristics data were only collected from children, as self-reported by their caregiver(s).
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| ID | Title | Description |
|---|---|---|
| BG000 | Summer Harvest Adventure (SHA) | Remote nutrition counseling, weekly produce harvesting, group nutrition education |
| BG001 | My Summer Plate (MSP) | Nutrition education packet |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | missing data |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Produce Intake | 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. | Outcome analyses included only participants with non-missing data; outcome data were missing for 3 participants in the MSP group who completed the study visit but did not have all measures collected. | Posted | Mean | Standard Deviation | dermal carotenoid score | Baseline and 10 weeks |
|
Enrollment until end of follow-up, up to 12 weeks
Adverse event reporting was for the children enrolled in the study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Summer Harvest Adventure (SHA) | Remote nutrition counseling, weekly produce harvesting, group nutrition education |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Colleen Spees | Ohio State University | 6142669234 | spees.11@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 3, 2022 | May 3, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Phase 2 prospective randomized controlled trial
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Clinical assessments for both groups (intervention and control) will be conducted by trained personnel that are blinded to participants' treatment arm assignment.
| My Summer Plate (MSP) | Behavioral | My Summer Plate (MSP) |
|
| Baseline and 10 weeks |
| Blood Pressure | Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain blood pressure readings | Baseline and 10 weeks |
| Height | Change in standing height will be measured to the nearest 1 mm using a standardized fixed stadiometer with a vertical backboard and moveable headboard | Baseline and 10 weeks |
| BMI Percentile | 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 | Baseline and 10 weeks |
| Result |
| Braun A, Portner J, Xu M, Weaver L, Pratt K, Darragh A, Spees CK. Preliminary Support for the Use of Motivational Interviewing to Improve Parent/Adult Caregiver Behavior for Obesity and Cancer Prevention. Int J Environ Res Public Health. 2023 Mar 7;20(6):4726. doi: 10.3390/ijerph20064726. |
| 36471397 | Result | Khalsa AS, Burton J, Bailey MT, Zhu J, Kelleher KJ, Maltz RM, Loman BR, Spees CK. Collection of biospecimens from parent-child dyads in a community garden-based nutrition intervention: protocol and feasibility. BMC Nutr. 2022 Dec 5;8(1):141. doi: 10.1186/s40795-022-00640-6. |
| 36457073 | Result | Hill EB, Chen L, Bailey MT, Singh Khalsa A, Maltz R, Kelleher K, Spees CK, Zhu J, Loman BR. Facilitating a high-quality dietary pattern induces shared microbial responses linking diet quality, blood pressure, and microbial sterol metabolism in caregiver-child dyads. Gut Microbes. 2022 Jan-Dec;14(1):2150502. doi: 10.1080/19490976.2022.2150502. |
| 33866297 | Result | Chen L, Sun X, Khalsa AS, Bailey MT, Kelleher K, Spees C, Zhu J. Accurate and reliable quantitation of short chain fatty acids from human feces by ultra high-performance liquid chromatography-high resolution mass spectrometry (UPLC-HRMS). J Pharm Biomed Anal. 2021 Jun 5;200:114066. doi: 10.1016/j.jpba.2021.114066. Epub 2021 Apr 6. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | self-report by caregiver | missing data | Count of Participants | Participants |
|
| Race (NIH/OMB) | self-report by caregiver | missing data | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | self report by caregiver | missing data | Count of Participants | Participants |
|
| Region of Enrollment | self-report by caregiver | Number | Participants |
|
Nutrition education packet |
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| Secondary | Weight | Change in weight will be recorded with a precision of 0.1 kilogram (kg) | Posted | Mean | Standard Deviation | kg | Baseline and 10 weeks |
|
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|
| Secondary | Family Engagement | 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). | Posted | Mean | Standard Deviation | score | Baseline and 10 weeks |
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| Secondary | Blood Pressure | Change in blood pressure will be measured using non-invasive brachial blood pressure assessment using oscillometric technology (automated devices) to obtain blood pressure readings | Outcome analyses included only participants with non-missing data; outcome data were missing for 1 participant in the SHA group who completed the study visit but did not have all measures collected | Posted | Mean | Standard Deviation | mmHg | Baseline and 10 weeks |
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| Secondary | Height | Change in standing height will be measured to the nearest 1 mm using a standardized fixed stadiometer with a vertical backboard and moveable headboard | Posted | Mean | Standard Deviation | cm | Baseline and 10 weeks |
|
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| Secondary | BMI Percentile | 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 | Outcome analyses included only participants with non-missing data; outcome data were missing for 2 participants in the MSP group who completed the study visit but did not have all measures collected | Posted | Mean | Standard Deviation | Percentile | Baseline and 10 weeks |
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| 0 |
| 96 |
| 0 |
| 96 |
| 0 |
| 96 |
| EG001 | My Summer Plate (MSP) | Nutrition education packet | 0 | 96 | 0 | 96 | 0 | 96 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |