- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01912989
Motivational Interviewing in NOURISH for Parents of Overweight Children (NOURISH+MI)
September 23, 2015 updated by: Virginia Commonwealth University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There is an urgent need for innovative approaches to pediatric obesity prevention and treatment.
There is also a demand for targeted strategies that reduce attrition and improve compliance with obesity treatment.
Intervening exclusively with parents of overweight children is a novel treatment approach, with demonstrated efficacy in reducing child body mass index (BMI) percentile.
Motivational interviewing (MI), a brief communication style for exploring and resolving ambivalence about change, may enhance treatment engagement when implemented as part of obesity interventions.
Further research investigating MI within pediatric obesity treatments is needed.
In the current application, the investigators are examining whether MI implemented with parents for the treatment of their children's overweight can improve treatment effects.
NOURISH+, a recently funded R01 (Nourishing Our Understanding of Role modeling to Improve Support and Health; PI, Mazzeo), is a culturally tailored parent intervention for overweight children ages 5-11.
NOURISH+ targets lower-income, African American participants, a group at increased risk for pediatric overweight and associated complications, and builds on pilot work which yielded significant reductions in child BMI percentile.
The investigators are adding an MI treatment into NOURISH+.
Specifically, we will randomly select 60 parents at enrollment and investigate if adding two brief MI sessions prior to the NOURISH+ group intervention will enhance treatment effects.
The investigators will be able to compare NOURISH+MI with participants from the two R01 treatment conditions (NOURISH+ and Control), matched on child ethnicity and gender.
The investigators hypothesize that children whose parents participate in NOURISH+ MI will demonstrate lower attrition and greater compliance with NOURISH+, ultimately leading to greater treatment effects, compared with children whose parents are randomized to NOURISH+ or a control group.
Study Type
Interventional
Enrollment (Actual)
64
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lifestyle counseling
NOURISH+ plus motivational interviewing
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of sessions attended
Time Frame: 8 weeks and 4-month follow up
|
8 weeks and 4-month follow up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Baseline child dietary intake and change in intake
Time Frame: baseline, 8 weeks, 4 month post
|
baseline, 8 weeks, 4 month post
|
|
Baseline child physical activity and change in activity
Time Frame: baseline, 8 weeks, 4-month post
|
baseline, 8 weeks, 4-month post
|
|
Baseline child BMI percentile and change in BMI
Time Frame: baseline, 8 weeks, 4-month post
|
baseline, 8 weeks, 4-month post
|
|
Baseline parent BMI and change in BMI
Time Frame: baseline, 8 weeks, 4-month post
|
baseline, 8 weeks, 4-month post
|
|
Baseline parent dietary intake and change in intake
Time Frame: baseline, 8 weeks, 4-month post
|
baseline, 8 weeks, 4-month post
|
|
Baseline parent physical activity and change in activity
Time Frame: baseline, 8 weeks, 4-month post
|
baseline, 8 weeks, 4-month post
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
June 28, 2013
First Submitted That Met QC Criteria
July 29, 2013
First Posted (Estimate)
July 31, 2013
Study Record Updates
Last Update Posted (Estimate)
September 24, 2015
Last Update Submitted That Met QC Criteria
September 23, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13CRP14570008
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Overweight and Obesity
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsCompletedOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Institut Investigacio Sanitaria Pere VirgiliCompletedObesity, Childhood | Overweight and Obesity | Overweight, ChildhoodSpain
-
National University Health System, SingaporeActive, not recruitingObesity | Overweight and/or Obesity | Overweight or Obese Adults | Overweight , ObesitySingapore
-
National Taiwan University HospitalCompleted
-
Holbaek SygehusUniversity of Copenhagen; University of Florida; University of Minnesota; Hebrew... and other collaboratorsRecruitingChildhood Overweight and ObesityDenmark
-
PfizerRecruitingObesity | Overnutrition | Nutrition Disorders | Overweight | Body Weight | Overweight or Obesity | Overweight and/or Obesity | Nutritional and Metabolic DiseasesUnited States
-
University of Texas Southwestern Medical CenterChildren's Medical Center DallasRecruitingPediatric Obesity | Pediatric Overweight | Overweight , ObesityUnited States
-
Universidade do Extremo Sul Catarinense - Unidade...RecruitingObesity | Overweight and Obesity | Obesity; Endocrine | Overweight, Obesity and Other HyperalimentationBrazil
-
Massachusetts General HospitalDenver Health and Hospital Authority; Prisma Health-UpstateCompletedOverweight and Obesity | Severe ObesityUnited States
-
Mexican National Institute of Public HealthUNICEFCompleted
Clinical Trials on Lifestyle counseling
-
York UniversityPublic Health Agency of Canada (PHAC)Unknown
-
Case Western Reserve UniversityNational Institutes of Health (NIH); American Heart AssociationCompletedStroke | Multiple Sclerosis | Rheumatoid ArthritisUnited States
-
University of PennsylvaniaNational Heart, Lung, and Blood Institute (NHLBI)CompletedHypertension | Obesity | Diabetes | Metabolic Syndrome | Hypercholesterolemia
-
UKK InstituteFinnish Institute of Occupational Health; Academy of Finland; Vitalmed Research...CompletedEffects of Weight Reduction on Sleep and Alertness in Long-distance Truck and Bus Drivers (SF-Truck)Abdominal ObesityFinland
-
Federal University of São PauloUnknownPain | Myofascial Pain | Facial Pain | Therapeutic Exercise | Temporomandibular Disorder SyndromeBrazil
-
Maura PalmeryUniversidad Católica San Antonio de Murcia; Research Centre for Food and Nutrition...UnknownMedication AdherenceItaly, Spain
-
The Miriam HospitalCompleted
-
Equipo Multidisciplinar Sanitario CS FoietesCompletedDiabetes Mellitus, Type 2
-
Kaohsiung Medical University Chung-Ho Memorial...No longer available