NCT01552642|CompletedPhase 3
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Sponsor study identifier
interventional
77
1 country
3
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)The overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 8, 2012
Actual (reported)March 13, 2012
Actual (reported)February 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 2015
Actual (reported)May 2015
Actual (reported)Feasibility
To assess the feasibility of an intervention combining 6 'in-person' group counseling sessions with a 1-year longitudinal web-based component to help parents of overweight children promote healthy behavior change.
1 year
Efficacy
To assess the effectiveness of this intervention program to assist parents of overweight and obese 3-6 year olds in promoting: (a) a modest reduction of child BMI-z scores, (b) healthy behavior changes (related to nutrition and physical activity) for their children, and (c) improved parenting skills.
1 year
Intervention Group
Control Group
The intervention group will have 6 weekly face-to-face meetings and will have access to a website.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
UW East Towne Clinic
Madison, Wisconsin, 53704, United States
UW Pediatrics at 20 S. Park St
Madison, Wisconsin, 53716, United States
UW Health West Towne Pediatrics
Madison, Wisconsin, 53717, United States
Spivack JG, Swietlik M, Alessandrini E, Faith MS. Primary care providers' knowledge, practices, and perceived barriers to the treatment and prevention of childhood obesity. Obesity (Silver Spring). 2010 Jul;18(7):1341-7. doi: 10.1038/oby.2009.410. Epub 2009 Nov 12.
Golan M, Weizman A, Apter A, Fainaru M. Parents as the exclusive agents of change in the treatment of childhood obesity. Am J Clin Nutr. 1998 Jun;67(6):1130-5. doi: 10.1093/ajcn/67.6.1130.
Ellen R Wald, MD
University of Wisconsin, Madison
77 participants (actual enrollment reported by the registry).
First Submitted
March 8, 2012
First Posted
March 13, 2012
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Ewing LJ, Cluss P, Goldstrohm S, Ulrich R, Colborn K, Cipriani L, Wald ER. Translating an evidence-based intervention for pediatric overweight to a primary care setting. Clin Pediatr (Phila). 2009 May;48(4):397-403. doi: 10.1177/0009922808330109. Epub 2009 Jan 21.
Wachs JE. Strategies to develop "interconnectedness". Part II Connection within the community. AAOHN J. 1992 Mar;40(3):144-6. No abstract available.
Shaw BR, McTavish F, Hawkins R, Gustafson DH, Pingree S. Experiences of women with breast cancer: exchanging social support over the CHESS computer network. J Health Commun. 2000 Apr-Jun;5(2):135-59. doi: 10.1080/108107300406866.
Gustafson DH, McTavish FM, Boberg E, Owens BH, Sherbeck C, Wise M, Pingree S, Hawkins RP. Empowering patients using computer based health support systems. Qual Health Care. 1999 Mar;8(1):49-56. doi: 10.1136/qshc.8.1.49. No abstract available.
Subar AF, Crafts J, Zimmerman TP, Wilson M, Mittl B, Islam NG, McNutt S, Potischman N, Buday R, Hull SG, Baranowski T, Guenther PM, Willis G, Tapia R, Thompson FE. Assessment of the accuracy of portion size reports using computer-based food photographs aids in the development of an automated self-administered 24-hour recall. J Am Diet Assoc. 2010 Jan;110(1):55-64. doi: 10.1016/j.jada.2009.10.007.
Vartanian VE, Bublik VG. [Late results of correction of flatfoot in children using an electro-myostimulation method]. Ortop Travmatol Protez. 1989 Feb;(2):26-9. Russian.
Savoye M, Shaw M, Dziura J, Tamborlane WV, Rose P, Guandalini C, Goldberg-Gell R, Burgert TS, Cali AM, Weiss R, Caprio S. Effects of a weight management program on body composition and metabolic parameters in overweight children: a randomized controlled trial. JAMA. 2007 Jun 27;297(24):2697-704. doi: 10.1001/jama.297.24.2697.
Golley RK, Magarey AM, Baur LA, Steinbeck KS, Daniels LA. Twelve-month effectiveness of a parent-led, family-focused weight-management program for prepubertal children: a randomized, controlled trial. Pediatrics. 2007 Mar;119(3):517-25. doi: 10.1542/peds.2006-1746.
Wald ER, Moyer SC, Eickhoff J, Ewing LJ. Treating childhood obesity in primary care. Clin Pediatr (Phila). 2011 Nov;50(11):1010-7. doi: 10.1177/0009922811410871. Epub 2011 Jun 6.
Primary Completion
May 2015
Actual (reported)Study Completion
May 2015
Actual (reported)Last Updated
July 29, 2015
Record last verified: 2015-07
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Source: ClinicalTrials.gov.
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