Family Influences to Prevent Childhood Obesity (4-Health)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Montana State University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
USDA Beltsville Human Nutrition Research Center
Information provided by (Responsible Party):
Wesley Lynch, Montana State University
ClinicalTrials.gov Identifier:
NCT01510587
First received: January 7, 2012
Last updated: January 11, 2012
Last verified: January 2012
  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.


Condition Intervention
Childhood Obesity
Behavioral: 4-Health Educational curriculum

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Montana State University:

Primary Outcome Measures:
  • Change child body mass index z-score. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in youth and parent self-reported physical activity. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]
  • Change in child and parent physical activity self-efficacy. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]
  • Change in child and parent dietary self-efficacy. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]
  • Change in child and parent body image. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]
  • Change in child quality of life via self-report and parent report. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]
  • Change in parent body mass index. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]
  • Change in child and parent diastolic and systolic blood pressure. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]
  • Change in child and parent heart rate. [ Time Frame: Baseline, end of program, 6 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment: 194
Study Start Date: July 2010
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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. 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.
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: 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. 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.
Other Name: 4-Health Educational Program

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510587

Locations
United States, Montana
Montana State University
Bozeman, Montana, United States, 59717
Sponsors and Collaborators
Montana State University
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
  More Information

No publications provided by Montana State University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wesley Lynch, Professor of Psychology, Montana State University
ClinicalTrials.gov Identifier: NCT01510587     History of Changes
Other Study ID Numbers: 4W3685, 2009-55215-05334
Study First Received: January 7, 2012
Last Updated: January 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Montana State University:
obesity
prevention
preteen
nutrition
physical activity
body image
family dynamics

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

ClinicalTrials.gov processed this record on July 26, 2014