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ChildPhase 3NCT01552642

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

A Phase 3 study testing face-to-face meetings and access to a website in people with Child and Obesity, run by University of Wisconsin, Madison at 3 sites 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 overall purpose of this study is to develop and implement an effective intervention program designed to prevent and treat obesity in young children. Read more about this study

Who is it for?
Any age
Conditions the study is for
Child, Obesity, Overweight
What is being tested?
face-to-face meetings and access to a website
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
3 sitesUnited States
Study dates
Feb 2013to May 2015
Phase
Phase 3
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • UW East Towne Clinic

    Madison, Wisconsin, 53704

  • UW Pediatrics at 20 S. Park St

    Madison, Wisconsin, 53716

  • UW Health West Towne Pediatrics

    Madison, Wisconsin, 53717

Other trials in United States

About this study

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

Read the 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).

Being tested
face-to-face meetings and access to a website
Keywords
Comprehensive Health Enhancement Support System (CHESS)
Medical subject headings
Obesity, Overweight

What participants receive

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

  • face-to-face meetings and access to a websiteBehavioural

    The intervention group will have 6 weekly face-to-face meetings and will have access to a website.

Study groups in NCT01552642
Study groupRoleWhat they receive
Intervention GroupActive comparatorIntervention Group
Receives: Behavioral: face-to-face meetings and access to a website
Control GroupNo interventionControl Group

What is being measured

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

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

Timeline

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

  1. First posted13 Mar 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionMay 2015
  4. Study completionMay 2015

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01552642
Sponsor's protocol ID
HD068783
Status last verified
Jul 2015
First submitted
8 Mar 2012
Last updated
29 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 19910934

  • 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.

    PubMed 9625084

  • 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.

    PubMed 19164134

  • Wachs JE. Strategies to develop "interconnectedness". Part II Connection within the community. AAOHN J. 1992 Mar;40(3):144-6. No abstract available.

    PubMed 1550624

  • 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.

    PubMed 11010346

  • 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.

    PubMed 10557670

  • 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.

    PubMed 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.

    PubMed 2786178

  • 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.

    PubMed 17595270

  • 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.

    PubMed 17332205

  • 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.

    PubMed 21646253

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing face-to-face meetings and access to a website in people with Child and Obesity, run by University of Wisconsin, Madison at 3 sites 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 29 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Feasibility (time frame: 1 year). The study lists 2 primary outcomes in all. 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 NCT01552642, which also lists 11 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 29 Jul 2015.

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