A Gardening Program to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children
Primary Purpose
Overweight
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Garden Fit
Sponsored by
About this trial
This is an interventional prevention trial for Overweight focused on measuring Childhood overweight, Gardening, Summer weight gain
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
Sites / Locations
- University of Wisconsin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Gardening Program
Control
Arm Description
Subjects received the standard of care for the summer.
Outcomes
Primary Outcome Measures
BMI
Secondary Outcome Measures
Fitness (as measured by VO2 Submax testing)
Resting Metabolic Rate
Fasting insulin
Fasting glucose
CRP
IL-6
Body Composition
Plasma Carotenoids
Total Energy Expenditure
Food Consumption (measured by FFQs)
Full Information
NCT ID
NCT00974727
First Posted
September 9, 2009
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT00974727
Brief Title
A Gardening Program to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children
Official Title
Use of Biomarkers to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
Childhood overweight, Gardening, Summer weight gain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gardening Program
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects received the standard of care for the summer.
Intervention Type
Other
Intervention Name(s)
Garden Fit
Other Intervention Name(s)
Garden Fit 2009
Intervention Description
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.
Primary Outcome Measure Information:
Title
BMI
Time Frame
June 2009 and August 2009
Secondary Outcome Measure Information:
Title
Fitness (as measured by VO2 Submax testing)
Time Frame
June 2009 and August 2009
Title
Resting Metabolic Rate
Time Frame
June 2009 and August 2009
Title
Fasting insulin
Time Frame
June 2009 and August 2009
Title
Fasting glucose
Time Frame
June 2009 and August 2009
Title
CRP
Time Frame
June 2009 and August 2009
Title
IL-6
Time Frame
June 2009 and August 2009
Title
Body Composition
Time Frame
June 2009 and August 2009
Title
Plasma Carotenoids
Time Frame
June 2009 and August 2009
Title
Total Energy Expenditure
Time Frame
June 2009 and August 2009
Title
Food Consumption (measured by FFQs)
Time Frame
June 2009 and August 2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dale Schoeller, Ph.D.
Organizational Affiliation
University of Wisconsin, Department of Nutritional Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12365956
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
17548760
Citation
Carrel AL, Clark RR, Peterson S, Eickhoff J, Allen DB. School-based fitness changes are lost during the summer vacation. Arch Pediatr Adolesc Med. 2007 Jun;161(6):561-4. doi: 10.1001/archpedi.161.6.561.
Results Reference
background
PubMed Identifier
15598600
Citation
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PubMed Identifier
17329660
Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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Citation
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Results Reference
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A Gardening Program to Assess Unhealthy Lifestyle Contributions to Summer Weight Gain in Children
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