A Gardening Program to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the impact of a summer gardening program on summer weight gain in overweight middle school children.

Detailed Description
-----------------
In the past two decades, the combination of unhealthy eating and physical inactivity has contributed to doubling the percentage of children and adolescents who are overweight. Childhood overweight is known to lead to increased risk for several morbidities in childhood and into adulthood including type 2 diabetes mellitus, hypertension, and cardiovascular disease. Recent data shows that children experience greater and more variable increases in BMI during summer vacation than during the school year. Our project aims to determine whether summer weight gain is due to a decrease in physical activity or an increase in daily calories as well as to assess the effectiveness of a summer gardening program on preventing summer body fat gain. We will randomize 40 middle-school children who are above the 95th percentile for BMI into either a control or intervention group. The control group will receive the standard of care and the intervention group will participate in Garden Fit, a summer gardening project at Troy Gardens in Madison, WI. As part of Garden Fit, subjects will participate in weeding, landscaping and trail maintenance activities as well as preparing meals twice a week with fresh foods from the gardens. We hypothesize that summer weight gain is due to a worsening of healthy lifestyle (decreased physical activity from school to summer and increased eating of high calorie snacks). Additionally, we hypothesize that an intervention that increases physical activity and provides increased access to healthy foods will reduce the trend of summer BMI increase.

Official Title
-----------------
Use of Biomarkers to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children

Conditions
-----------------
Overweight

Intervention / Treatment
-----------------
* Other: Garden Fit


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Middle school child aged 10-14 years BMI at or above the 85th percentile for height and weight Able to attend 8-week summer program and clinic visits Exclusion Criteria: Any known metabolic disorder Any physical disability that prevents or limits physical activity Claustrophobia

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gardening Program<br> | Other: Garden Fit<br>* 8-week summer gardening program. 9am-12pm on Monday, Wednesday, Friday and 9am-12:30pm on Tuesday and Thursday. Activities included gardening (preparing soil for planting, planting seeds and seedlings, mulching, weeding, watering, and harvesting), preparing meals with fresh foods from the garden, and other garden activities and games.<br>* Other names: Garden Fit 2009;|
| No Intervention: Control<br>Subjects received the standard of care for the summer. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI |  | June 2009 and August 2009 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fitness (as measured by VO2 Submax testing) |  | June 2009 and August 2009 | 
| Resting Metabolic Rate |  | June 2009 and August 2009 | 
| Fasting insulin |  | June 2009 and August 2009 | 
| Fasting glucose |  | June 2009 and August 2009 | 
| CRP |  | June 2009 and August 2009 | 
| IL-6 |  | June 2009 and August 2009 | 
| Body Composition |  | June 2009 and August 2009 | 
| Plasma Carotenoids |  | June 2009 and August 2009 | 
| Total Energy Expenditure |  | June 2009 and August 2009 | 
| Food Consumption (measured by FFQs) |  | June 2009 and August 2009 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood overweight, Gardening, Summer weight gain