Clinical trial NCT00974727: 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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: Childhood overweight
Gardening
Summer weight gain
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 12
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: BMI
timeFrame: June 2009 and August 2009
Secondary outcomes:
measure: Fitness (as measured by VO2 Submax testing)
timeFrame: June 2009 and August 2009
measure: Resting Metabolic Rate
timeFrame: June 2009 and August 2009
measure: Fasting insulin
timeFrame: June 2009 and August 2009
measure: Fasting glucose
timeFrame: June 2009 and August 2009
measure: CRP
timeFrame: June 2009 and August 2009
measure: IL-6
timeFrame: June 2009 and August 2009
measure: Body Composition
timeFrame: June 2009 and August 2009
measure: Plasma Carotenoids
timeFrame: June 2009 and August 2009
measure: Total Energy Expenditure
timeFrame: June 2009 and August 2009
measure: Food Consumption (measured by FFQs)
timeFrame: June 2009 and August 2009
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Department of Nutritional Sciences
name: Dale Schoeller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1001/jama.288.14.1728.
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. doi: 10.1093/geronb/58.2.s110.
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.
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. doi: 10.1016/j.eatbeh.2004.08.002.
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. doi: 10.2105/AJPH.2005.080754. Epub 2007 Feb 28.
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. doi: 10.1001/jama.295.13.1549.
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. doi: 10.1056/NEJM199709253371301.
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. doi: 10.1089/jwh.2006.0329.
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. No abstract available.
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. doi: 10.1093/ajcn/75.5.818.
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. doi: 10.1093/ajcn/87.4.846.
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.
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. doi: 10.1001/archpedi.159.10.963.