Motivational Interviewing in NOURISH for Parents of Overweight Children

Overweight and Obesity Clinical Trial

— NOURISH+MI  

Official title:

Motivational Interviewing in NOURISH for Parents of Overweight Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912989
• Other study ID #: 13CRP14570008
• Status: Completed
• Phase: N/A
• First received: June 28, 2013
• Last updated: September 23, 2015
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Overweight
• Overweight and Obesity

Intervention

Behavioral:
• Lifestyle counseling
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.

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	American Heart Association

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of sessions attended		8 weeks and 4-month follow up	No
Secondary	Baseline child dietary intake and change in intake		baseline, 8 weeks, 4 month post	No
Secondary	Baseline child physical activity and change in activity		baseline, 8 weeks, 4-month post	No
Secondary	Baseline child BMI percentile and change in BMI		baseline, 8 weeks, 4-month post	No
Secondary	Baseline parent BMI and change in BMI		baseline, 8 weeks, 4-month post	No
Secondary	Baseline parent dietary intake and change in intake		baseline, 8 weeks, 4-month post	No
Secondary	Baseline parent physical activity and change in activity		baseline, 8 weeks, 4-month post	No