Project Fun: Parents And Youth Together

NCT ID: NCT01799759

Last Updated: 2017-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

276 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2016-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Addressing the epidemic of obesity is a national priority. Currently almost a third of children and two thirds of adults are overweight or obese. Obesity-related chronic health problems originating in childhood are often life-long. Overweight and obesity result from detrimental patterns of dietary intake and physical activity. These obesity-producing lifestyles are established in childhood and are often carried into adulthood, when they become more refractory to change. Research has demonstrated that programs involving parents and children in a family context have been the most effective in preventing and treating childhood obesity.

Research Question 1: How many parents and children agree to participate, complete data collection and complete at least 80% of the intervention? Research Question 2: What reasons are given by those not completing the protocol and what suggestions are offered by those who do complete the protocol? Research Question 3: What is the relationship of parent or child perceptions of authoritative parenting, child perceptions of family models and support for healthy eating, physical activity, or reduced sedentary time, and of parenting stress, self-efficacy, confidence, and eating behavior on child BMI? Research Question 4: Do parent or child perceptions of authoritative parenting, diet, physical activity, fitness or body composition; child perceptions of family models and support for healthy eating, physical activity, or reduced sedentary time; or parent perceptions of parenting stress, self-efficacy, confidence, and eating behavior change across the study time period? Research Question 5: Are there relationships between study completion and child or parent BMI, child or parent gender, parenting stress, self-efficacy, confidence, and eating behavior?

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Childhood Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Online intervention for parent and child

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

Group Type EXPERIMENTAL

Online intervention

Intervention Type BEHAVIORAL

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

Instruments only

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

Group Type OTHER

Completion of instruments only

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Online intervention

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

Intervention Type BEHAVIORAL

Completion of instruments only

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* None
Minimum Eligible Age

9 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Marquette University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marilyn Frenn, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Marquette University College of Nursing

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marquette University College of Nursing

Milwaukee, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HR-1625

Identifier Type: -

Identifier Source: org_study_id