NCT01361243

Brief Summary

The purpose of this study is to evaluate the efficacy of a parent intervention (NOURISH+) aimed at reducing the problem of overweight and obesity in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
730

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

6.8 years

First QC Date

May 24, 2011

Last Update Submit

February 21, 2018

Conditions

Overweight and Obesity

Keywords

Pediatric OverweightPediatric Obesity

Outcome Measures

Primary Outcomes (1)

  • Child BMI

    baseline, post-testing, 4-month, and 10-month follow-up

Secondary Outcomes (2)

  • Child dietary intake, quality of life, and physical activity

    baseline, post-testing, 4-month, and 10-month follow-up

  • Parental BMI, dietary intake, and physical activity levels

    baseline, post-testing, 4-month, and 10-month follow-up

Study Arms (2)

NOURISH+

EXPERIMENTAL

Participants will receive a 6-week face-to-face intervention, NOURISH+. Weekly topics teach parents skills to role model and encourage healthy lifestyle behaviors for their children.

Behavioral: NOURISH+

Wellness Group

PLACEBO COMPARATOR

Participants will receive an in-person "Family Wellness Night" followed by 6 mailings of information regarding pediatric overweight and obesity.

Behavioral: Wellness Group

Interventions

NOURISH+BEHAVIORAL

6 week face-to-face parent intervention.

NOURISH+
Wellness GroupBEHAVIORAL

1 week face-to-face family group followed by 6 informational mailings on childhood overweight and obesity.

Wellness Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents/caregivers must be at least 18 years old
  • Parents/caregivers must have a child between the ages of 5 and 11 with a BMI \> the 85th percentile, who primarily resides in the caregiver's home
  • Parents/caregivers need to speak English, be able to follow basic instructions, and perform simple exercises

You may not qualify if:

  • Non-ambulatory parents/caregivers
  • Pregnant parents/caregivers
  • Parents/caregivers who have a medical condition that might be negatively impacted by exercise
  • Parents/caregivers who have a psychiatric diagnosis that would impair their ability to respond to assessments or participate in a group
  • Parents whose children have a medical or developmental condition that precludes weight loss using conventional diet and exercise methods

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Related Publications (1)

  • Kwitowski M, Bean MK, Mazzeo SE. An exploration of factors influencing attrition from a pediatric weight management intervention. Obes Res Clin Pract. 2017 Mar-Apr;11(2):233-240. doi: 10.1016/j.orcp.2016.08.002. Epub 2016 Aug 17.

    PMID: 27544283DERIVED

MeSH Terms

Conditions

OverweightObesityPediatric Obesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Suzanne E Mazzeo, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2011

First Posted

May 26, 2011

Study Start

April 1, 2011

Primary Completion

January 31, 2018

Study Completion

January 31, 2018

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)