NCT01799759

Brief Summary

The proposed study is a continuation of a randomized, controlled pilot effectiveness trial conducted in schools wherein the feasibility and completion of the trial by parents and children will now additionally be examined in after school and YMCA connected programs. The intervention for this study is Project FUN and Project FUN with Parents. Project FUN is an 8 module online program for children in 4th through 8th grade. Project FUN with Parents is a 6 module online program for their parent. Children and parents will be recruited through the afterschool and YMCA connected programs. Those agreeing to participate will be randomly assigned to a first intervention or second intervention session (waiting list control group). Surveys and measures will be collected for everyone pre-intervention, after the first session completion and after the second session completion to create a waiting list control group. Hypothesis 1: Body composition and dietary fat of children who complete Project FUN and have a parent complete Project FUN with Parents will be lower on completion than children who only complete instruments. Hypothesis 2: Fruit and vegetable intake, physical activity and fitness of children who complete Project FUN and have a parent complete Project FUN with Parents will be greater on completion than children who only complete instruments.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

3.1 years

First QC Date

February 25, 2013

Last Update Submit

September 22, 2017

Conditions

Childhood Obesity

Keywords

Body Mass PercentileAuthoritative parentingOnline interventionsPrevention

Outcome Measures

Primary Outcomes (1)

  • child body mass percentile

    Child height and weight are measured and the body mass percentile calculated using the Centers for Disease Control and Prevention algorithm for adjustment by age and gender.

    6-12 weeks

Study Arms (2)

Online intervention for parent and child

EXPERIMENTAL

Children complete 8 online modules of Project FUN Parents complete 6 modules of Project FUN for Parents

Behavioral: Online intervention

Instruments only

OTHER

The waiting list control group only completes instruments and body composition, fitness measures

Other: Completion of instruments only

Interventions

Online interventionBEHAVIORAL

Child online intervention is 8 modules based on the Health Promotion/Transtheoretical Model Parent online intervention is 6 modules based on enhancing authoritative parenting,support and role models for improved nutrition, physical activity and health child body mass percentile

Online intervention for parent and child
Completion of instruments onlyOTHER

Parent and child subejects in the waiting list control only complete surveys, body composition and fitness tests

Instruments only

Eligibility Criteria

Age9 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children in 4th through 8th grade and a parent(s)who can read and write English. Must be able to come to Marquette University or Milwaukee area YMCA for pre and post test data collection and to complete online modules.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marquette University College of Nursing

Milwaukee, Wisconsin, 53233, United States

Location

MeSH Terms

Conditions

Pediatric Obesity

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Marilyn Frenn, PhD, RN

    Marquette University College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 27, 2013

Study Start

February 1, 2013

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

September 25, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)