Childhood ObesityNCT01799759
Project Fun: Parents And Youth Together
A study testing Online intervention and Completion of instruments only in people with Childhood Obesity, run by Marquette University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- Online intervention and Completion of instruments only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Mar 2016
- Phase
- Interventional
- 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 9 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Marquette University College of Nursing
Milwaukee, Wisconsin, 53233
About this study
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.
Read more
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.
Read the detailed 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?
- Conditions
- Childhood Obesity
- Being tested
- Online intervention, Completion of instruments only
- Keywords
- Body Mass Percentile, Authoritative parenting, Online interventions, Prevention
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online interventionBehavioural
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
Completion of instruments onlyOther
Parent and child subejects in the waiting list control only complete surveys, body composition and fitness tests
| Study group | Role | What they receive |
|---|---|---|
| Online intervention for parent and child | Experimental | Children complete 8 online modules of Project FUN Parents complete 6 modules of Project FUN for Parents Receives: Behavioral: Online intervention |
| Instruments only | Other | The waiting list control group only completes instruments and body composition, fitness measures Receives: Other: Completion of instruments only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marilyn Frenn, PhD, RN, Principal investigator, Marquette University College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799759
- Sponsor's protocol ID
- HR-1625
- Status last verified
- Sep 2017
- First submitted
- 25 Feb 2013
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project Fun: Parents And Youth Together
- ClinicalTrials.gov ID
- NCT01799759
- Acronym / sponsor ID
- HR-1625
- Conditions
- Childhood Obesity
- Keywords
- Body Mass Percentile, Authoritative parenting, Online interventions, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online intervention for parent and child | Experimental | Behavioral: Online interventionChildren complete 8 online modules of Project FUN Parents complete 6 modules of Project FUN for Parents |
| Instruments only | Other | Other: Completion of instruments onlyThe waiting list control group only completes instruments and body composition, fitness measures |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online interventionChild 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 | Behavioural | Online intervention for parent and child |
| Completion of instruments onlyParent and child subejects in the waiting list control only complete surveys, body composition and fitness tests | Other | Instruments only |
Primary outcome
child body mass percentile
Time frame: 6-12 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilyn Frenn, PhD, RN principal investigator
Marquette University College of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online intervention and Completion of instruments only in people with Childhood Obesity, run by Marquette University at 1 site 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 1 inclusion and 1 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 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
child body mass percentile (time frame: 6-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Sep 2017; AzTrials last refreshed its copy on 1 Nov 2026.