Project Fun: Parents And Youth Together

Childhood Obesity Clinical Trial

Official title:

Project Fun: Parents And Youth Together

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01799759
• Other study ID #: HR-1625
• Status: Completed
• Phase: N/A
• First received: February 25, 2013
• Last updated: September 22, 2017
• Start date: February 2013
• Est. completion date: March 2016

Study information

• Verified date: September 2017
• Source: Marquette University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 15 Years

Eligibility

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:

Related Conditions & MeSH terms

• Childhood Obesity
• Pediatric Obesity

Intervention

Behavioral:
• 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

Other:
• Completion of instruments only
Parent and child subejects in the waiting list control only complete surveys, body composition and fitness tests

Locations

Country	Name	City	State
United States	Marquette University College of Nursing	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Marquette University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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