NCT01510587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 7, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

3.9 years

First QC Date

January 7, 2012

Last Update Submit

January 28, 2015

Conditions

Keywords

obesitypreventionpreteennutritionphysical activitybody imagefamily dynamics

Outcome Measures

Primary Outcomes (1)

  • Change child body mass index z-score.

    Baseline, end of program, 6 month follow up

Secondary Outcomes (8)

  • Change in youth and parent self-reported physical activity.

    Baseline, end of program, 6 month follow up

  • Change in child and parent physical activity self-efficacy.

    Baseline, end of program, 6 month follow up

  • Change in child and parent dietary self-efficacy.

    Baseline, end of program, 6 month follow up

  • Change in child and parent body image.

    Baseline, end of program, 6 month follow up

  • Change in child quality of life via self-report and parent report.

    Baseline, end of program, 6 month follow up

  • +3 more secondary outcomes

Study Arms (2)

4-Health Educational curriculum

EXPERIMENTAL

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

Healthy Living Information

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: 4-Health Educational Program
4-Health Educational curriculum

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.

Healthy Living Information

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Parent of 8-12 year old child in 4-H Youth Development Programs in Montana
  • Child of parent enrolled in study

You may not qualify if:

  • Parent of child age outside the 8-12 year old range at start of trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montana State University

Bozeman, Montana, 59717, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Pediatric ObesityObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Wesley Lynch, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR
  • Lynn Paul, PhD, RD

    Montana State University

    PRINCIPAL INVESTIGATOR
  • Jill Martz, PhD

    Montana State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychology

Study Record Dates

First Submitted

January 7, 2012

First Posted

January 16, 2012

Study Start

July 1, 2010

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations