NCT02185248

Brief Summary

The objective of this study was to determine the effectiveness of a novel Wellness Action Plan aimed at 1) improving parent recall of diet and activity plans 2) increasing follow-through with plans and 3) aiding parents in identifying their child's weight category.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2013

Shorter than P25 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

March 1, 2013

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

8 months

First QC Date

July 2, 2014

Last Update Submit

March 20, 2015

Conditions

Childhood Obesity

Keywords

Pediatric ObesityBody Mass IndexWeight PerceptionCounselingHealth Behavior

Outcome Measures

Primary Outcomes (2)

  • Diet plan recall directly after visit

    Parents are given a questionnaire which asks whether they made a diet plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.

    On day of primary visit

  • Activity plan recall directly after visit

    Parents are given a questionnaire which asks whether they made an activity plan with their physician for their child during the visit and whether they will attempt to follow-through with the plan made.

    On day of primary visit, directly after seeing physician

Secondary Outcomes (7)

  • Diet plan recall/follow-through 1 month post visit

    4 weeks after primary visit

  • Diet plan recall/follow-through 3 months post visit

    12 weeks after primary visit

  • Activity plan recall/follow-through 1 month post visit

    4 weeks after primary visit

  • Activity plan recall/follow-through 3 months post visit

    12 weeks after primary visit

  • BMI category identification directly after the visit

    On day of primary visit

  • +2 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

General clinical counseling in regards to child's BMI category and necessary changes to diet and activity regimen.

Wellness Plan

EXPERIMENTAL

Received a wellness action plan. The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.

Behavioral: Wellness Action Plan

Interventions

Wellness Action PlanBEHAVIORAL

The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.

Wellness Plan

Eligibility Criteria

Age30 Months - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between the ages of 2.5 and 14 years, regardless of baseline BMI
  • Presented for a well child visit at a pediatric clinic serving primarily Medicaid-insured children in Milwaukee, Wisconsin

You may not qualify if:

  • Patients in foster care
  • Parents and patients who were non-English speaking
  • Patients who were being seen by a specialist for weight management.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Downtown Health Center

Milwaukee, Wisconsin, 53233, United States

Location

Related Publications (1)

  • Kharofa RY, Copeland KA, Sucharew H, Meurer JR. Randomized controlled trial of a Wellness Action Plan to promote healthy diet and activity in pediatric primary care. Prev Med Rep. 2015 Oct 21;2:899-905. doi: 10.1016/j.pmedr.2015.10.008. eCollection 2015.

    PMID: 26844166DERIVED

MeSH Terms

Conditions

Pediatric ObesityHealth Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

  • John R Meurer, MD, MBA

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Primary Care Research Fellow

Study Record Dates

First Submitted

July 2, 2014

First Posted

July 9, 2014

Study Start

March 1, 2013

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

US(1)