Family Influences to Prevent Childhood Obesity (4-Health)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01510587
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : January 29, 2015
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Wesley Lynch, Montana State University

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.

Condition or disease Intervention/treatment Phase
Childhood Obesity Behavioral: 4-Health Educational curriculum Behavioral: Healthy Living Information Not Applicable

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  (Clinical Trial)
Actual Enrollment : 194 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth
Study Start Date : July 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

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 Name: 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.

Primary Outcome Measures :
  1. Change child body mass index z-score. [ Time Frame: Baseline, end of program, 6 month follow up ]

Secondary Outcome Measures :
  1. Change in youth and parent self-reported physical activity. [ Time Frame: Baseline, end of program, 6 month follow up ]
  2. Change in child and parent physical activity self-efficacy. [ Time Frame: Baseline, end of program, 6 month follow up ]
  3. Change in child and parent dietary self-efficacy. [ Time Frame: Baseline, end of program, 6 month follow up ]
  4. Change in child and parent body image. [ Time Frame: Baseline, end of program, 6 month follow up ]
  5. Change in child quality of life via self-report and parent report. [ Time Frame: Baseline, end of program, 6 month follow up ]
  6. Change in parent body mass index. [ Time Frame: Baseline, end of program, 6 month follow up ]
  7. Change in child and parent diastolic and systolic blood pressure. [ Time Frame: Baseline, end of program, 6 month follow up ]
  8. Change in child and parent heart rate. [ Time Frame: Baseline, end of program, 6 month follow up ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01510587

United States, Montana
Montana State University
Bozeman, Montana, United States, 59717
Sponsors and Collaborators
Montana State University
USDA Beltsville Human Nutrition Research Center
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Wesley Lynch, Professor of Psychology, Montana State University Identifier: NCT01510587     History of Changes
Other Study ID Numbers: 4W3685
2009-55215-05334 ( Other Grant/Funding Number: USDA-NIFA-AFRI )
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: January 29, 2015
Last Verified: January 2015

Keywords provided by Wesley Lynch, Montana State University:
physical activity
body image
family dynamics

Additional relevant MeSH terms:
Pediatric Obesity
Nutrition Disorders
Body Weight
Signs and Symptoms