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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01552642
• Other study ID #: HD068783
• Status: Completed
• Phase: Phase 3
• First received: March 8, 2012
• Last updated: July 27, 2015
• Start date: February 2013
• Est. completion date: May 2015

Study information

• Verified date: July 2015
• 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 overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Child
• Obesity
• Overweight

Intervention

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.

Locations

Country	Name	City	State
United States	UW East Towne Clinic	Madison	Wisconsin
United States	UW Health West Towne Pediatrics	Madison	Wisconsin
United States	UW Pediatrics at 20 S. Park St	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 t — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No