Family Influences to Prevent Childhood Obesity (4-Health)

January 28, 2015 updated by: Wesley Lynch, Montana State University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Montana
      • Bozeman, Montana, United States, 59717
        • Montana State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 4-Health Educational curriculum
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).
Behavioral: 4-Health Educational curriculum
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.
Other Names:
  • 4-Health Educational Program
ACTIVE_COMPARATOR: Healthy Living Information
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.
Behavioral: Healthy Living Information
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change child body mass index z-score.
Time Frame: Baseline, end of program, 6 month follow up
Baseline, end of program, 6 month follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in youth and parent self-reported physical activity.
Time Frame: Baseline, end of program, 6 month follow up
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
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
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
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
Baseline, end of program, 6 month follow up
Change in parent body mass index.
Time Frame: Baseline, end of program, 6 month follow up
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
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
Baseline, end of program, 6 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montana State University

Collaborators

USDA Beltsville Human Nutrition Research Center

Investigators

  • Principal Investigator: Wesley Lynch, PhD, Montana State University
  • Principal Investigator: Lynn Paul, PhD, RD, Montana State University
  • Principal Investigator: Jill Martz, PhD, Montana State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ACTUAL)

June 1, 2014

Study Completion (ACTUAL)

June 1, 2014

Study Registration Dates

First Submitted

January 7, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (ESTIMATE)

January 16, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

January 29, 2015

Last Update Submitted That Met QC Criteria

January 28, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4W3685
  • 2009-55215-05334 (OTHER_GRANT: USDA-NIFA-AFRI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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