A School-based Gardening Obesity Intervention for Low-income Minority Children

NCT02668744 | Completed DMC

• 2 other identifiers: 1R01HL123865-01A1R01HL123865
• Study Type: interventional
• Target: 3,302
• Locations: 1 country
• Sites: 16

Brief Summary

The investigators recently completed an NIH R21 grant, which was a randomized controlled trial (RCT) to test the effects of a gardening, nutrition, and cooking program in 375 low-income Hispanic students living in Los Angeles. Preliminary results from this study show that intervention compared to the control students have reductions in BMI parameters and waist circumference, increases in daily intake of dietary fiber and vegetables, and improved lipid profiles. The investigators want to expand and replicate this study by: a) using a cluster randomized school design; b) implementing the program during school hours; c) increasing sample size; d) lengthening the intervention period to one school year; e) collecting comprehensive metabolic measurements on the child; f) enhancing family workshops; g) collecting more parental data; and h) developing and evaluating sustainability strategies. Thus, the overall goal of this project is to test the effects of a large school-based gardening, nutrition, and cooking RCT (called "Sprouts") on dietary intake, dietary-related behaviors, obesity, and related metabolic disorders in low-income Hispanic youth and their families in Central Texas. Sixteen elementary schools will be randomized to either: 1) Sprouts intervention or 2) Control (delayed intervention). At each intervention school, the investigators will build edible gardens; form and train Garden Leadership Coalitions (GLCs); teach 20 Sprouts in-school lessons to the students; and teach nine family-based Sprouts lessons throughout school year. The following measures will be obtained for students at baseline and post-intervention: height, weight, BMI, waist circumference, body composition (via bioimpedance), blood pressure, glucose, insulin, and lipids (via voluntary fasting blood draws), dietary intake, and related psychosocial behaviors (e.g., preference/motivation/self-efficacy to eat FV). The investigators will also measure anthropometrics, dietary intake, and related dietary psychosocial variables on the parents at baseline and post-intervention. After the intervention year, the investigators will provide a series of training workshops and resources to the GLCs and schoolteachers to sustain the Sprouts program in subsequent years. The investigators will measure the sustainability employed by each school by process logs/surveys, structured interviews, and school observations.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• To test the effect of the Sprouts intervention on the changes in dietary intake (fruit and vegetables servings) in the children.

  Evaluation measures will be collected one time at baseline and end of the school year in both arms (intervention and control schools). A child questionnaire will be administered and include questions about dietary intake of fruits and vegetables to assess their eating habits.

  One year

• To test the effect of the Sprouts intervention on the changes in BMI in the children.

  Evaluation measures will be collected one time at baseline and end of the school year in both arms (intervention and control schools). Measurements will occur during the first four weeks of school in the fall and the last four weeks of school in the spring. Weight will be measured using a SECA (model 869) digital scale to the nearest 0.1 kg, and height will be measured using a wall-mounted stadiometer to the nearest 0.1 cm. BMI (kg/m2) and BMI percentiles for CDC age- and gender-specific values will be determined using EpiInfo 2005.

  One year

Secondary Outcomes (2)

• To test the effect of the Sprouts intervention on the changes in dietary intake (fruit and vegetables servings) in the parents.

  One year

• To test the effect of the Sprouts intervention on changes in BMI in the parents.

  4 years

Study Arms (2)

Intervention

EXPERIMENTAL

TX Sprouts

Behavioral: Intervention

Control

PLACEBO COMPARATOR

Delayed Intervention

Behavioral: Intervention

Interventions

Intervention BEHAVIORAL

The intervention consists of building edible gardens at each the eight participating and eligible schools. Educators will be provided to lead 18 gardening, nutrition and cooking lessons throughout the school year intervention to all 3-5th grade students. Nine gardening, nutrition, and cooking classes will be taught to parents every month. Garden Leadership Coalitions (GLCs), made up of parents, teachers and school staff, will be formed and training/resources provided to help with adoption of the program. Training and resources will be provided to the GLCs and teachers in the 2nd year to assist with sustainability.

Control; Intervention

Eligibility Criteria

• Age: 8 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Weight status: Normal weight children (age- and sex-specific BMI\<85th percentile based on CDC BMI growth charts68) and overweight and obese children (BMI≥85th percentile).
• Gender and Age: Students in 3rd-5th grades (8 to 11 y) and their parents
• Hispanic Origin: This study will include all ethnicities/races; however, the selected schools are \>50% Hispanic, and therefore, we expect the majority of our students and parents to be Hispanic.

You may not qualify if:

• Children or parents presently taking medication(s) or diagnosed with any disease that could influence dietary intake or body composition
• Previously diagnosed with any major illness since birth (e.g. chronic birth asphyxia, cancer, etc.)
• Any physical, cognitive, or psychological disability that would prevent participation in the study.

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• The University of Texas Health Science Center, Houston: collaborator
• Seton Healthcare Family: collaborator
• Texas AgriLife Extension Service: collaborator

Study Sites (16)

Barbara Jordan Elementary

Austin, Texas, 78724, United States

Location

Decker Elementary

Austin, Texas, 78724, United States

Location

Oak Meadows Elementary

Austin, Texas, 78724, United States

Location

Pleasant Hill Elementary

Austin, Texas, 78745, United States

Location

Casey Elementary

Austin, Texas, 78748, United States

Location

Hart Elementary

Austin, Texas, 78753, United States

Location

McBee Elementary

Austin, Texas, 78758, United States

Location

Booker T. Washington

Elgin, Texas, 78621, United States

Location

Elgin Elementary

Elgin, Texas, 78621, United States

Location

Neidig Elementary

Elgin, Texas, 78621, United States

Location

Carver Elementary

Georgetown, Texas, 78626, United States

Location

Mitchell Elementary

Georgetown, Texas, 78626, United States

Location

Pickett Elementary

Georgetown, Texas, 78626, United States

Location

Purl Elementary

Georgetown, Texas, 78626, United States

Location

Callison Elementary

Round Rock, Texas, 78664, United States

Location

Voigt Elementary

Round Rock, Texas, 78664, United States

Location

Related Publications (10)

• Haushalter K, Burgermaster M, Hudson E, Landry MJ, Sharma SV, Davis JN. An Increase in Food Insecurity Correlated with an Increase in Plasma Triglycerides among Latinx Children. J Nutr. 2024 Feb;154(2):565-573. doi: 10.1016/j.tjnut.2023.12.024. Epub 2023 Dec 17.

  PMID: 38110183 DERIVED

• Jeans MR, Landry MJ, Vandyousefi S, Hudson EA, Burgermaster M, Bray MS, Chandra J, Davis JN. Effects of a School-Based Gardening, Cooking, and Nutrition Cluster Randomized Controlled Trial on Unprocessed and Ultra-Processed Food Consumption. J Nutr. 2023 Jul;153(7):2073-2084. doi: 10.1016/j.tjnut.2023.04.013. Epub 2023 Apr 26.

  PMID: 37116658 DERIVED

• Vandyousefi S, Ranjit N, Landry MJ, Jeans M, Ghaddar R, Davis JN. Dietary Psychosocial Mediators of Vegetable Intake in Schoolchildren From Low-Income and Racial and Ethnic Minority US Families: Findings From the Texas Sprouts Intervention. J Acad Nutr Diet. 2023 Aug;123(8):1187-1196.e1. doi: 10.1016/j.jand.2023.03.015. Epub 2023 Mar 28.

  PMID: 36996935 DERIVED

• Davis JN, Landry MJ, Vandyousefi S, Jeans MR, Hudson EA, Hoelscher DM, van den Berg AE, Perez A. Effects of a School-Based Nutrition, Gardening, and Cooking Intervention on Metabolic Parameters in High-risk Youth: A Secondary Analysis of a Cluster Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2250375. doi: 10.1001/jamanetworkopen.2022.50375.

  PMID: 36626172 DERIVED

• Jeans MR, Ghaddar R, Vandyousefi S, Landry MJ, Gray MJ, Leidy HJ, Whittaker TA, Bray MS, Davis JN. Distinct racial and ethnic metabolic syndrome characteristics: A comparative assessment in low-income children 7-10 years of age. Pediatr Obes. 2022 Oct;17(10):e12925. doi: 10.1111/ijpo.12925. Epub 2022 May 12.

  PMID: 35560860 DERIVED

• Jeans MR, Landry MJ, Asigbee FM, Vandyousefi S, Ghaddar R, Bray MS, Leidy HJ, Davis JN. Comparison of School vs Home Breakfast Consumption with Cardiometabolic and Dietary Parameters in Low-Income, Multiracial/Ethnic Elementary School-Aged Children. J Acad Nutr Diet. 2022 Apr;122(4):833-847. doi: 10.1016/j.jand.2021.10.014. Epub 2021 Oct 9.

  PMID: 34634512 DERIVED

• Landry MJ, van den Berg AE, Hoelscher DM, Asigbee FM, Vandyousefi S, Ghaddar R, Jeans MR, Waugh L, Nikah K, Sharma SV, Davis JN. Impact of a School-Based Gardening, Cooking, Nutrition Intervention on Diet Intake and Quality: The TX Sprouts Randomized Controlled Trial. Nutrients. 2021 Sep 1;13(9):3081. doi: 10.3390/nu13093081.

  PMID: 34578959 DERIVED

• Davis JN, Perez A, Asigbee FM, Landry MJ, Vandyousefi S, Ghaddar R, Hoover A, Jeans M, Nikah K, Fischer B, Pont SJ, Richards D, Hoelscher DM, Van Den Berg AE. School-based gardening, cooking and nutrition intervention increased vegetable intake but did not reduce BMI: Texas sprouts - a cluster randomized controlled trial. Int J Behav Nutr Phys Act. 2021 Jan 23;18(1):18. doi: 10.1186/s12966-021-01087-x.

  PMID: 33485354 DERIVED

• Landry MJ, van den Berg AE, Asigbee FM, Vandyousefi S, Ghaddar R, Davis JN. Child Compared with Parent Perceptions of Child-Level Food Security. Curr Dev Nutr. 2019 Sep 27;3(10):nzz106. doi: 10.1093/cdn/nzz106. eCollection 2019 Oct.

  PMID: 31637366 DERIVED

• Landry MJ, Ranjit N, Hoelscher DM, Asigbee FM, Vandyousefi S, Ghaddar R, Davis JN. Validity and Reliability of an Expanded Vegetable Questionnaire Among Elementary School Children. Curr Dev Nutr. 2019 Jul 4;3(8):nzz080. doi: 10.1093/cdn/nzz080. eCollection 2019 Aug.

  PMID: 31414072 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Jaimie N Davis, PhD

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2016
• First Posted: January 29, 2016
• Study Start: September 1, 2016
• Primary Completion: May 30, 2019
• Study Completion: April 1, 2020
• Last Updated: October 7, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (16)