Family Influences to Prevent Childhood Obesity

NCT ID: NCT01510587

Last Updated: 2015-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-06-30

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.

Conditions

Childhood Obesity

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

4-Health Educational curriculum

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Healthy Living Information

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

4-Health Educational Program

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: collaborator

Montana State University

OTHER

Sponsor Role: lead

Responsible Party

Wesley Lynch

Professor of Psychology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wesley Lynch, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Lynn Paul, PhD, RD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Jill Martz, PhD

Role: PRINCIPAL_INVESTIGATOR

Montana State University

Locations

Montana State University

Bozeman, Montana, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 22471650 (View on PubMed)

Other Identifiers

2009-55215-05334

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4W3685

Identifier Type: -

Identifier Source: org_study_id