Clinical trial NCT01510587: Family Influences to Prevent Childhood Obesity
Official title: Family Influences to Prevent Childhood Obesity: An Integrated Research and Outreach Program for Parents of Montana 4-H Youth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Keywords: obesity
prevention
preteen
nutrition
physical activity
body image
family dynamics
Lead sponsor: Montana State University
Sponsor class: OTHER
Collaborators: name: USDA Beltsville Human Nutrition Research Center
First posted: 2012-01-16
Enrollment: 194
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change child body mass index z-score.
timeFrame: Baseline, end of program, 6 month follow up
Secondary outcomes:
measure: Change in youth and parent self-reported physical activity.
timeFrame: Baseline, end of program, 6 month follow up
measure: Change in child and parent physical activity self-efficacy.
timeFrame: Baseline, end of program, 6 month follow up
measure: Change in child and parent dietary self-efficacy.
timeFrame: Baseline, end of program, 6 month follow up
measure: Change in child and parent body image.
timeFrame: Baseline, end of program, 6 month follow up
measure: Change in child quality of life via self-report and parent report.
timeFrame: Baseline, end of program, 6 month follow up
measure: Change in parent body mass index.
timeFrame: Baseline, end of program, 6 month follow up
measure: Change in child and parent diastolic and systolic blood pressure.
timeFrame: Baseline, end of program, 6 month follow up
measure: Change in child and parent heart rate.
timeFrame: Baseline, end of program, 6 month follow up
Other outcomes:
Locations:
city: Bozeman
country: United States
facility: Montana State University
state: Montana
Study officials:
affiliation: Montana State University
name: Wesley Lynch, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montana State University
name: Lynn Paul, PhD, RD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montana State University
name: Jill Martz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.