Childhood Obesity4-HealthNCT01510587
Family Influences to Prevent Childhood Obesity
A study testing 4-Health Educational curriculum and Healthy Living Information in people with Childhood Obesity, run by Montana State University at 1 site in United States.
Trial summary
The main goal of this project is to develop, deliver, and assess the efficacy of a parent-centered educational program (4-Health) designed to prevent preteen children from becoming overweight. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Childhood Obesity
- What is being tested?
- 4-Health Educational curriculum and Healthy Living Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parent of 8-12 year old child in 4-H Youth Development Programs in Montana
- Child of parent enrolled in study
Who cannot join
- Parent of child age outside the 8-12 year old range at start of trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth
The main goal of this project is to develop, deliver, and assess the efficacy of a parent-centered educational program (4-Health) designed to prevent preteen children from becoming overweight.
Read the detailed description
Previous studies suggest that parents can play a key role in preventing childhood obesity. Program objectives are to increase parents' knowledge and skills related to nutrition, physical activity, and best parenting practices. Developed from a successful existing program, the proposed program will include a novel classroom curriculum coupled with outside exercises, online resources, and a strong social support network. The curriculum will be developed with input from stakeholders during year 1 and implemented during years 2 and 3. The target groups are children and parents participating in 4-H Youth Development Programs in Montana. Intervention effectiveness will be assessed by comparing objective and self-report data between-groups (intervention vs. control) and within-groups (pre- to post-intervention and at 6 month follow-up). Physiological measures, including resting heart rate, blood pressure, body weight and age- and gender-specific BMI z-scores of children, are expected to show significant improvement among children of parents receiving the intervention compared to a mailed written materials control group. In addition, positive changes are anticipated in outcome measures provided by parents and children, including levels of daily physical activity and specific food and nutrition behaviors. Positive changes in parents' attitudes about diet, body image, and their perceived feeding practices before versus after intervention and at 6 month follow-up are also expected. This project will lead to improved understanding of how parents influence child obesity and improved interventions to prevent obesity.
- Conditions
- Childhood Obesity
- Being tested
- 4-Health Educational curriculum, Healthy Living Information
- Keywords
- obesity, prevention, preteen, nutrition, physical activity, body image, family dynamics
- Medical subject headings
- Pediatric Obesity, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4-Health Educational curriculumBehavioural
Also called 4-Health Educational Program
During the intervention, parents meet about every 3 weeks (90 min/session) in small groups with facilitators. During meetings classroom activities aim to integrate 3 areas: 1) parents' knowledge about healthy diets, physical activity and improved body image; 2) parents' understanding, skills and potential roles as positive change-agents (i.e., parenting and behavior management); and 3) parents' learning and practicing cognitive-behavioral exercises that encourage specific skills within the family/home setting. Between monthly meetings, participants explore a suggested online websites or facilitator-assigned questions and provide feedback. The majority of outside time/assignments for parents is spent doing take-home activities with their preteen child and family.
Healthy Living InformationBehavioural
During the Healthy Living Information intervention, participants receive packets delivered to their homes by mail at intervals similar to the meeting intervals for the educational curriculum intervention. (10 total packets.) Approximately every three weeks between late September 2011 and April 2012, corresponding approximately to the meeting times for the 4-Health Educational Program, participants in the Healthy Living Information control group receive mailed packets of information.
| Study group | Role | What they receive |
|---|---|---|
| 4-Health Educational curriculum | Experimental | Parents participate in 10 face-to-face educational sessions delivered by Extension Agents at individual county locations over a 8-month period (fall to spring). Receives: Behavioral: 4-Health Educational curriculum |
| Healthy Living Information | Active comparator | Participants receive 10 mailed packets of written information derived from USDA's MyPlate website on approximately the same schedule as meetings of the experimental group. Receives: Behavioral: Healthy Living Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change child body mass index z-score.
Measured: Baseline, end of program, 6 month follow up
Secondary outcomes (8)
Change in youth and parent self-reported physical activity.
Measured: Baseline, end of program, 6 month follow up
Change in child and parent physical activity self-efficacy.
Measured: Baseline, end of program, 6 month follow up
Change in child and parent dietary self-efficacy.
Measured: Baseline, end of program, 6 month follow up
Change in child and parent body image.
Measured: Baseline, end of program, 6 month follow up
Change in child quality of life via self-report and parent report.
Measured: Baseline, end of program, 6 month follow up
Change in parent body mass index.
Measured: Baseline, end of program, 6 month follow up
Change in child and parent diastolic and systolic blood pressure.
Measured: Baseline, end of program, 6 month follow up
Change in child and parent heart rate.
Measured: Baseline, end of program, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2012 (estimated)
- Study startJul 2010
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montana State University
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Responsible party
- Principal investigator, Wesley Lynch, Montana State University
- Investigators
- Wesley Lynch, PhD, Principal investigator, Montana State UniversityLynn Paul, PhD, RD, Principal investigator, Montana State UniversityJill Martz, PhD, Principal investigator, Montana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01510587
- Sponsor's protocol ID
- 4W3685
- Other IDs
- 2009-55215-05334, 2009
- Acronym
- 4-Health
- Status last verified
- Jan 2015
- First submitted
- 7 Jan 2012
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lynch WC, Martz J, Eldridge G, Bailey SJ, Benke C, Paul L. Childhood obesity prevention in rural settings: background, rationale, and study design of '4-Health,' a parent-only intervention. BMC Public Health. 2012 Apr 2;12:255. doi: 10.1186/1471-2458-12-255.
PubMed 22471650
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth
- ClinicalTrials.gov ID
- NCT01510587
- Acronym / sponsor ID
- 4-Health / 4W3685
- Conditions
- Childhood Obesity
- Keywords
- obesity, prevention, preteen, nutrition, physical activity, body image, family dynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Montana State UniversityUniversity, hospital or other
- Collaborators
- USDA Beltsville Human Nutrition Research Center
- Study start
- Jul 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Jan 2012 (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 main goal of this project is to develop, deliver, and assess the efficacy of a parent-centered educational program (4-Health) designed to prevent preteen children from becoming overweight.
Detailed description
Previous studies suggest that parents can play a key role in preventing childhood obesity. Program objectives are to increase parents' knowledge and skills related to nutrition, physical activity, and best parenting practices. Developed from a successful existing program, the proposed program will include a novel classroom curriculum coupled with outside exercises, online resources, and a strong social support network. The curriculum will be developed with input from stakeholders during year 1 and implemented during years 2 and 3. The target groups are children and parents participating in 4-H Youth Development Programs in Montana. Intervention effectiveness will be assessed by comparing objective and self-report data between-groups (intervention vs. control) and within-groups (pre- to post-intervention and at 6 month follow-up). Physiological measures, including resting heart rate, blood pressure, body weight and age- and gender-specific BMI z-scores of children, are expected to show significant improvement among children of parents receiving the intervention compared to a mailed written materials control group. In addition, positive changes are anticipated in outcome measures provided by parents and children, including levels of daily physical activity and specific food and nutrition behaviors. Positive changes in parents' attitudes about diet, body image, and their perceived feeding practices before versus after intervention and at 6 month follow-up are also expected. This project will lead to improved understanding of how parents influence child obesity and improved interventions to prevent obesity.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4-Health Educational curriculum | Experimental | Behavioral: 4-Health Educational curriculumParents participate in 10 face-to-face educational sessions delivered by Extension Agents at individual county locations over a 8-month period (fall to spring). |
| Healthy Living Information | Active comparator | Behavioral: Healthy Living InformationParticipants receive 10 mailed packets of written information derived from USDA's MyPlate website on approximately the same schedule as meetings of the experimental group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parent of 8-12 year old child in 4-H Youth Development Programs in Montana
- Child of parent enrolled in study
Key exclusion criteria (1 listed)
- Parent of child age outside the 8-12 year old range at start of trial
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 |
|---|---|---|
| 4-Health Educational curriculumAlso: 4-Health Educational ProgramDuring the intervention, parents meet about every 3 weeks (90 min/session) in small groups with facilitators. During meetings classroom activities aim to integrate 3 areas: 1) parents' knowledge about healthy diets, physical activity and improved body image; 2) parents' understanding, skills and potential roles as positive change-agents (i.e., parenting and behavior management); and 3) parents' learning and practicing cognitive-behavioral exercises that encourage specific skills within the family/home setting. Between monthly meetings, participants explore a suggested online websites or facilitator-assigned questions and provide feedback. The majority of outside time/assignments for parents is spent doing take-home activities with their preteen child and family. | Behavioural | 4-Health Educational curriculum |
| Healthy Living InformationDuring the Healthy Living Information intervention, participants receive packets delivered to their homes by mail at intervals similar to the meeting intervals for the educational curriculum intervention. (10 total packets.) Approximately every three weeks between late September 2011 and April 2012, corresponding approximately to the meeting times for the 4-Health Educational Program, participants in the Healthy Living Information control group receive mailed packets of information. | Behavioural | Healthy Living Information |
Primary outcome
Change child body mass index z-score.
Time frame: Baseline, end of program, 6 month follow up
8 secondary outcomes
Change in youth and parent self-reported physical activity.
Time frame: Baseline, end of program, 6 month follow up
Change in child and parent physical activity self-efficacy.
Time frame: Baseline, end of program, 6 month follow up
Change in child and parent dietary self-efficacy.
Time frame: Baseline, end of program, 6 month follow up
Change in child and parent body image.
Time frame: Baseline, end of program, 6 month follow up
Change in child quality of life via self-report and parent report.
Time frame: Baseline, end of program, 6 month follow up
Change in parent body mass index.
Time frame: Baseline, end of program, 6 month follow up
Change in child and parent diastolic and systolic blood pressure.
Time frame: Baseline, end of program, 6 month follow up
Change in child and parent heart rate.
Time frame: Baseline, end of program, 6 month follow up
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 29 Jan 2015.
- Derived from this study: PubMed 22471650Lynch WC, Martz J, Eldridge G, Bailey SJ, Benke C, Paul L. Childhood obesity prevention in rural settings: background, rationale, and study design of '4-Health,' a parent-only intervention. BMC Public Health. 2012 Apr 2;12:255. doi: 10.1186/1471-2458-12-255.
- Benke C, Bailey S, Eldridge G, Martz J, Paul L. 4-Health: A Programmatic Evaluation of a Parent-Based Childhood Obesity Prevention Program. Journal of Youth Development 8(3). 2013.Link provided by the sponsor.
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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.
Wesley Lynch, PhD principal investigator
Montana State University
Lynn Paul, PhD, RD principal investigator
Montana State University
Jill Martz, PhD principal investigator
Montana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 4-Health Educational curriculum and Healthy Living Information in people with Childhood Obesity, run by Montana State 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 2 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 29 Jan 2015. 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?
Change child body mass index z-score. (time frame: Baseline, end of program, 6 month follow up). 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 NCT01510587, which also lists 1 linked publication.
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 Jan 2015.