An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children - Full Text View

Purpose

The overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.

Condition	Intervention	Phase
Child Obesity Overweight	Behavioral: face-to-face meetings and access to a website	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:

Feasibility [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.
Efficacy [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	156
Study Start Date:	February 2013
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Intervention Group Intervention Group	Behavioral: face-to-face meetings and access to a website The intervention group will have 6 weekly face-to-face meetings and will have access to a website.
No Intervention: Control Group Control Group

Detailed Description:

Study procedures and interventions:

Pre-intervention: a full-day training will occur with a physician and nurse from each clinic site to be trained as "champions" in counseling.

Intervention:

A letter of introduction will be mailed to potential subjects whose child was seen in the last 6 months for a well-child exam whose BMI is greater than or equal to the 85th percentile. After informed consent is obtained, the subjects will be randomized to the intervention or control group. One parent may join the study.

Groups of 10 to 12 parents of overweight and obese 3 to 6 year olds will meet once weekly for 6 weeks at 5:30 to 6:30 pm with the "nurse champion" in the primary care office. Topics to be presented and discussed include authoritative parenting, using the food plan "Go, Slow, and Whoa", increasing physical activity, and behavior change strategies. Sessions will be audiotaped and independently audited to confirm program fidelity. Parenting skills will be discussed at every session.

The intervention group will have access to a website. This site will include information services (instant library with health topics related to nutrition and physical activity and answers to frequently asked questions), web links to other pre-screened sources of information on nutrition and physical activity, local resources for current activities for children and families, personal stories (emphasizing authoritative parenting), interactive discussion group and Ask the Expert (questions will be answered within 48 hours and usually sooner).

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

one parent of a 3-6 year old child with a BMI greater than or equal to the 85th percentile
Internet access
English speaking

Exclusion Criteria:

Children with a developmental disorder
Children with a chronic underlying disease that may contribute to obesity
Children taking medication that may interfere with a healthy weight

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01552642

Contacts

Contact: Stacey Moyer, MSN

608-262-9531

scmoyer@pediatrics.wisc.edu

Locations

United States, Wisconsin
UW Health West Towne Pediatrics	Not yet recruiting
Madison, Wisconsin, United States, 53717
Contact: Stacey Moyer, MSN 608-262-9531 scmoyer@wisc.edu
Principal Investigator: Ellen R Wald, MD
UW Pediatrics at 20 S. Park St	Not yet recruiting
Madison, Wisconsin, United States, 53716
Contact: Stacey Moyer, MSN 608-262-9531 scmoyer@wisc.edu
Principal Investigator: Ellen Wald, MD

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

Principal Investigator:

Ellen R Wald, MD

University of Wisconsin, Madison

More Information

Publications:

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.

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.

Wald ER, Moyer SC, Eickhoff J, Ewing LJ. Treating childhood obesity in primary care. Clin Pediatr (Phila). 2011 Nov;50(11):1010-7. Epub 2011 Jun 6.

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. Epub 2009 Jan 21.

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. 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.

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. Epub 2009 Jan 21.

Wachs JE. Strategies to develop "interconnectedness". Part II Connection within the community. AAOHN J. 1992 Mar;40(3):144-6.

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.

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.

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. PubMed PMID: 20102828.

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.

Responsible Party:	University of Wisconsin, Madison
ClinicalTrials.gov Identifier:	NCT01552642 History of Changes
Other Study ID Numbers:	HD068783
Study First Received:	March 8, 2012
Last Updated:	January 15, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:

Comprehensive Health Enhancement Support System (CHESS)

Additional relevant MeSH terms:

Obesity
Overweight
Overnutrition

Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013