NCT01912989

Brief Summary

The purpose of this study is to investigate if a brief, motivational interviewing intervention (NOURISH+MI) can improve retention and treatment adherence for parents enrolled in an intervention for their child's overweight (NOURISH+). The investigators hypothesize that children whose parents participate in NOURISH+MI will demonstrate lower attrition and greater adherence with NOURISH+, ultimately leading to greater treatment effects, compared with children whose parents are randomized to NOURISH+ or a control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration 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

January 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

September 24, 2015

Status Verified

September 1, 2015

Enrollment Period

2.6 years

First QC Date

June 28, 2013

Last Update Submit

September 23, 2015

Conditions

Keywords

motivational interviewingobesityparent

Outcome Measures

Primary Outcomes (1)

  • Number of sessions attended

    8 weeks and 4-month follow up

Secondary Outcomes (6)

  • Baseline child dietary intake and change in intake

    baseline, 8 weeks, 4 month post

  • Baseline child physical activity and change in activity

    baseline, 8 weeks, 4-month post

  • Baseline child BMI percentile and change in BMI

    baseline, 8 weeks, 4-month post

  • Baseline parent BMI and change in BMI

    baseline, 8 weeks, 4-month post

  • Baseline parent dietary intake and change in intake

    baseline, 8 weeks, 4-month post

  • +1 more secondary outcomes

Study Arms (1)

Lifestyle counseling

EXPERIMENTAL

NOURISH+ plus motivational interviewing

Behavioral: Lifestyle counseling

Interventions

Parents will participate in one telephone and one in person session of motivational interviewing prior to their participation in an 8 week parent-exclusive treatment focusing on parenting skills to improve their child's overweight.

Lifestyle counseling

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
  • have a child between the ages of 5 and 11
  • have a child with a BMI \> the 85th%ile
  • the eligible child primarily resides in the caregiver's home
  • English speaking

You may not qualify if:

  • non-ambulatory
  • pregnant
  • have a medical condition that might be negatively impacted by exercise 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 are also ineligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (1)

  • Bean MK, Jeffers AJ, Tully CB, Thornton LM, Mazzeo SE. Motivational interviewing with parents of overweight children: study design and methods for the NOURISH + MI study. Contemp Clin Trials. 2014 Mar;37(2):312-21. doi: 10.1016/j.cct.2014.02.001. Epub 2014 Feb 12.

    PMID: 24530488BACKGROUND

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Melanie K Bean, PhD

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2013

First Posted

July 31, 2013

Study Start

January 1, 2013

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

September 24, 2015

Record last verified: 2015-09

Locations