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

Primary Purpose

Child, Obesity, Overweight

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
face-to-face meetings and access to a website
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Child focused on measuring Comprehensive Health Enhancement Support System (CHESS)

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UW East Towne Clinic
  • UW Pediatrics at 20 S. Park St
  • UW Health West Towne Pediatrics

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Intervention Group

Control Group

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 8, 2012
Last Updated
July 27, 2015
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01552642
Brief Title
An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children
Official Title
An Interactive Web-based Intervention to Achieve Healthy Weight in Young Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Child, Obesity, Overweight
Keywords
Comprehensive Health Enhancement Support System (CHESS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Active Comparator
Arm Description
Intervention Group
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control Group
Intervention Type
Behavioral
Intervention Name(s)
face-to-face meetings and access to a website
Intervention Description
The intervention group will have 6 weekly face-to-face meetings and will have access to a website.
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
1 year
Title
Efficacy
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen R Wald, MD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
UW East Towne Clinic
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
Facility Name
UW Pediatrics at 20 S. Park St
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53716
Country
United States
Facility Name
UW Health West Towne Pediatrics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53717
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19910934
Citation
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Results Reference
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PubMed Identifier
9625084
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. doi: 10.1093/ajcn/67.6.1130.
Results Reference
background
PubMed Identifier
19164134
Citation
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.
Results Reference
background
PubMed Identifier
1550624
Citation
Wachs JE. Strategies to develop "interconnectedness". Part II Connection within the community. AAOHN J. 1992 Mar;40(3):144-6. No abstract available.
Results Reference
background
PubMed Identifier
11010346
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. doi: 10.1080/108107300406866.
Results Reference
background
PubMed Identifier
10557670
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. doi: 10.1136/qshc.8.1.49. No abstract available.
Results Reference
background
PubMed Identifier
20102828
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.
Results Reference
background
PubMed Identifier
2786178
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.
Results Reference
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PubMed Identifier
17595270
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 trial. JAMA. 2007 Jun 27;297(24):2697-704. doi: 10.1001/jama.297.24.2697.
Results Reference
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PubMed Identifier
17332205
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. doi: 10.1542/peds.2006-1746.
Results Reference
result
PubMed Identifier
21646253
Citation
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Results Reference
result

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

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