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

Overweight Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974727
• Other study ID #: MSN106189
• Status: Completed
• Phase: N/A
• First received: September 9, 2009
• Last updated: October 1, 2015
• Start date: May 2009
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 14 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Overweight
• Weight Gain

Intervention

Other:
• Garden Fit
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.

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. — View Citation

Carrel AL, Clark RR, Peterson SE, Nemeth BA, Sullivan J, Allen DB. Improvement of fitness, body composition, and insulin sensitivity in overweight children in a school-based exercise program: a randomized, controlled study. Arch Pediatr Adolesc Med. 2005 Oct;159(10):963-8. — View Citation

Ferraro KF, Thorpe RJ Jr, Wilkinson JA. The life course of severe obesity: does childhood overweight matter? J Gerontol B Psychol Sci Soc Sci. 2003 Mar;58(2):S110-9. — View Citation

Gillis L, McDowell M, Bar-Or O. Relationship between summer vacation weight gain and lack of success in a pediatric weight control program. Eat Behav. 2005 Feb;6(2):137-43. — View Citation

Gutin B, Barbeau P, Owens S, Lemmon CR, Bauman M, Allison J, Kang HS, Litaker MS. Effects of exercise intensity on cardiovascular fitness, total body composition, and visceral adiposity of obese adolescents. Am J Clin Nutr. 2002 May;75(5):818-26. — View Citation

Gutin B. Child obesity can be reduced with vigorous activity rather than restriction of energy intake. Obesity (Silver Spring). 2008 Oct;16(10):2193-6. doi: 10.1038/oby.2008.348. — View Citation

Hull HR, Morrow ML, Heesch KC, Dinger MK, Han JL, Fields DA. Effect of the summer months on body weight and composition in college women. J Womens Health (Larchmt). 2007 Dec;16(10):1510-5. — View Citation

Johnson L, Mander AP, Jones LR, Emmett PM, Jebb SA. Energy-dense, low-fiber, high-fat dietary pattern is associated with increased fatness in childhood. Am J Clin Nutr. 2008 Apr;87(4):846-54. — View Citation

Ogden CL, Carroll MD, Curtin LR, McDowell MA, Tabak CJ, Flegal KM. Prevalence of overweight and obesity in the United States, 1999-2004. JAMA. 2006 Apr 5;295(13):1549-55. — View Citation

Ogden CL, Flegal KM, Carroll MD, Johnson CL. Prevalence and trends in overweight among US children and adolescents, 1999-2000. JAMA. 2002 Oct 9;288(14):1728-32. — View Citation

von Hippel PT, Powell B, Downey DB, Rowland NJ. The effect of school on overweight in childhood: gain in body mass index during the school year and during summer vacation. Am J Public Health. 2007 Apr;97(4):696-702. Epub 2007 Feb 28. — View Citation

Wang YC, Bleich SN, Gortmaker SL. Increasing caloric contribution from sugar-sweetened beverages and 100% fruit juices among US children and adolescents, 1988-2004. Pediatrics. 2008 Jun;121(6):e1604-14. doi: 10.1542/peds.2007-2834. — View Citation

Whitaker RC, Wright JA, Pepe MS, Seidel KD, Dietz WH. Predicting obesity in young adulthood from childhood and parental obesity. N Engl J Med. 1997 Sep 25;337(13):869-73. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI		June 2009 and August 2009	No
Secondary	Fitness (as measured by VO2 Submax testing)		June 2009 and August 2009	No
Secondary	Resting Metabolic Rate		June 2009 and August 2009	No
Secondary	Fasting insulin		June 2009 and August 2009	No
Secondary	Fasting glucose		June 2009 and August 2009	No
Secondary	CRP		June 2009 and August 2009	No
Secondary	IL-6		June 2009 and August 2009	No
Secondary	Body Composition		June 2009 and August 2009	No
Secondary	Plasma Carotenoids		June 2009 and August 2009	No
Secondary	Total Energy Expenditure		June 2009 and August 2009	No
Secondary	Food Consumption (measured by FFQs)		June 2009 and August 2009	No