Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bozeman, Montana 59717


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Parent of 8-12 year old child in 4-H Youth Development Programs in Montana - Child of parent enrolled in study Exclusion Criteria: - Parent of child age outside the 8-12 year old range at start of trial


Study is Available At:


Original ID:

4W3685


NCT ID:

NCT01510587


Secondary ID:

2009-55215-05334


Study Acronym:

4-Health


Brief Title:

Family Influences to Prevent Childhood Obesity


Official Title:

Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Montana State University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificatio


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

194


Enrollment Type:

Actual


Overall Contact Information

Official Name:Wesley Lynch, PhD
Principal Investigator
Montana State University

Study Dates

Start Date:July 2010
Completion Date:June 2014
Completion Type:Actual
Primary Completion Date:June 2014
Primary Completion Type:Actual
Verification Date:January 2015
Last Changed Date:January 28, 2015
First Received Date:January 7, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in child and parent heart rate.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in child and parent diastolic and systolic blood pressure.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in parent body mass index.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in child quality of life via self-report and parent report.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in child and parent body image.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in child and parent dietary self-efficacy.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in child and parent physical activity self-efficacy.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change in youth and parent self-reported physical activity.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change child body mass index z-score.
Time Frame:Baseline, end of program, 6 month follow up
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:4-Health Educational curriculum
Description: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 famil
Arm Name:4-Health Educational curriculum
Other Name:4-Health Educational Program
Intervention Type:Behavioral
Name:Healthy Living Information
Description: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.
Arm Name:Healthy Living Information

Study Arms

Study Arm Type:Experimental
Arm Name:4-Health Educational curriculum
Description: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).
Study Arm Type:Active Comparator
Arm Name:Healthy Living Information
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Montana State University
Agency Class:U.S. Fed
Agency Type:Collaborator
Agency Name:USDA Beltsville Human Nutrition Research Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.