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OverweightNCT00974727

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

A study testing Garden Fit in people with Overweight, run by University of Wisconsin, Madison at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 10 to 14 years
Conditions the study is for
Overweight
What is being tested?
Garden Fit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
May 2009to Aug 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 14 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Any known metabolic disorder
  • Any physical disability that prevents or limits physical activity
  • Claustrophobia

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Wisconsin

    Madison, Wisconsin, 53706

Other trials in United States

About this study

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

The purpose of this study is to examine the impact of a summer gardening program on summer weight gain in overweight middle school children.

Read the 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.

Conditions
Overweight
Being tested
Garden Fit
Keywords
Childhood overweight, Gardening, Summer weight gain
Medical subject headings
Overweight, Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Garden FitOther

    Also called Garden Fit 2009

    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.

Study groups in NCT00974727
Study groupRoleWhat they receive
Gardening ProgramExperimentalNot described
Receives: Other: Garden Fit
ControlNo interventionSubjects received the standard of care for the summer.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI

    Measured: June 2009 and August 2009

Secondary outcomes (10)

  1. Fitness (as measured by VO2 Submax testing)

    Measured: June 2009 and August 2009

  2. Resting Metabolic Rate

    Measured: June 2009 and August 2009

  3. Fasting insulin

    Measured: June 2009 and August 2009

  4. Fasting glucose

    Measured: June 2009 and August 2009

  5. CRP

    Measured: June 2009 and August 2009

  6. IL-6

    Measured: June 2009 and August 2009

  7. Body Composition

    Measured: June 2009 and August 2009

  8. Plasma Carotenoids

    Measured: June 2009 and August 2009

  9. Total Energy Expenditure

    Measured: June 2009 and August 2009

  10. Food Consumption (measured by FFQs)

    Measured: June 2009 and August 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionAug 2009
  4. Study completionAug 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00974727
Sponsor's protocol ID
MSN106189
Status last verified
Sep 2009
First submitted
9 Sep 2009
Last updated
5 Oct 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 12365956

  • 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.

    PubMed 12646600

  • 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.

    PubMed 17548760

  • 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.

    PubMed 15598600

  • 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.

    PubMed 17329660

  • 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.

    PubMed 16595758

  • 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.

    PubMed 9302300

  • 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.

    PubMed 18062766

  • 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.

    PubMed 18719647

  • 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.

    PubMed 11976154

  • 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.

    PubMed 18400706

  • 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.

    PubMed 18519465

  • 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.

    PubMed 16203942

Questions about this trial

What is this clinical trial studying?

A study testing Garden Fit in people with Overweight, run by University of Wisconsin, Madison at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

BMI (time frame: June 2009 and August 2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00974727, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2015.

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