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Family Influences to Prevent Childhood Obesity (4-Health)

Primary Purpose

Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
4-Health Educational curriculum
Healthy Living Information
Sponsored by
Montana State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring obesity, prevention, preteen, nutrition, physical activity, body image, family dynamics

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montana State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

4-Health Educational curriculum

Healthy Living Information

Arm 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).

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.

Outcomes

Primary Outcome Measures

Change child body mass index z-score.

Secondary Outcome Measures

Change in youth and parent self-reported physical activity.
Change in child and parent physical activity self-efficacy.
Change in child and parent dietary self-efficacy.
Change in child and parent body image.
Change in child quality of life via self-report and parent report.
Change in parent body mass index.
Change in child and parent diastolic and systolic blood pressure.
Change in child and parent heart rate.

Full Information

First Posted
January 7, 2012
Last Updated
January 28, 2015
Sponsor
Montana State University
Collaborators
USDA Beltsville Human Nutrition Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01510587
Brief Title
Family Influences to Prevent Childhood Obesity
Acronym
4-Health
Official Title
Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montana State University
Collaborators
USDA Beltsville Human Nutrition Research Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity
Keywords
obesity, prevention, preteen, nutrition, physical activity, body image, family dynamics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4-Health Educational curriculum
Arm Type
Experimental
Arm 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).
Arm Title
Healthy Living Information
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
4-Health Educational curriculum
Other Intervention Name(s)
4-Health Educational Program
Intervention 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 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.
Intervention Type
Behavioral
Intervention Name(s)
Healthy Living Information
Intervention 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.
Primary Outcome Measure Information:
Title
Change child body mass index z-score.
Time Frame
Baseline, end of program, 6 month follow up
Secondary Outcome Measure Information:
Title
Change in youth and parent self-reported physical activity.
Time Frame
Baseline, end of program, 6 month follow up
Title
Change in child and parent physical activity self-efficacy.
Time Frame
Baseline, end of program, 6 month follow up
Title
Change in child and parent dietary self-efficacy.
Time Frame
Baseline, end of program, 6 month follow up
Title
Change in child and parent body image.
Time Frame
Baseline, end of program, 6 month follow up
Title
Change in child quality of life via self-report and parent report.
Time Frame
Baseline, end of program, 6 month follow up
Title
Change in parent body mass index.
Time Frame
Baseline, end of program, 6 month follow up
Title
Change in child and parent diastolic and systolic blood pressure.
Time Frame
Baseline, end of program, 6 month follow up
Title
Change in child and parent heart rate.
Time Frame
Baseline, end of program, 6 month follow up

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley Lynch, PhD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynn Paul, PhD, RD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jill Martz, PhD
Organizational Affiliation
Montana State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montana State University
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59717
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22471650
Citation
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.
Results Reference
derived

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Family Influences to Prevent Childhood Obesity

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