Overweight and ObesityNOURISH+MINCT01912989
Motivational Interviewing in NOURISH for Parents of Overweight Children
A study testing Lifestyle counseling in people with Overweight and Obesity, run by Virginia Commonwealth University at 1 site in United States.
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+). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Lifestyle counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Overweight and Obesity
- Being tested
- Lifestyle counseling
- Keywords
- motivational interviewing, obesity, parent
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle counselingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | NOURISH+ plus motivational interviewing Receives: Behavioral: Lifestyle counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of sessions attended
Measured: 8 weeks and 4-month follow up
Secondary outcomes (6)
Baseline child dietary intake and change in intake
Measured: baseline, 8 weeks, 4 month post
Baseline child physical activity and change in activity
Measured: baseline, 8 weeks, 4-month post
Baseline child BMI percentile and change in BMI
Measured: baseline, 8 weeks, 4-month post
Baseline parent BMI and change in BMI
Measured: baseline, 8 weeks, 4-month post
Baseline parent dietary intake and change in intake
Measured: baseline, 8 weeks, 4-month post
Baseline parent physical activity and change in activity
Measured: baseline, 8 weeks, 4-month post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2013 (estimated)
- Study startJan 2013
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Melanie K Bean, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01912989
- Sponsor's protocol ID
- 13CRP14570008
- Acronym
- NOURISH+MI
- Status last verified
- Sep 2015
- First submitted
- 28 Jun 2013
- Last updated
- 24 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24530488
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Interviewing in NOURISH for Parents of Overweight Children
- ClinicalTrials.gov ID
- NCT01912989
- Acronym / sponsor ID
- NOURISH+MI / 13CRP14570008
- Conditions
- Overweight and Obesity
- Keywords
- motivational interviewing, obesity, parent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jan 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 31 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Lifestyle counselingNOURISH+ plus motivational interviewing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle counselingParents 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. | Behavioural | Lifestyle counseling |
Primary outcome
Number of sessions attended
Time frame: 8 weeks and 4-month follow up
6 secondary outcomes
Baseline child dietary intake and change in intake
Time frame: baseline, 8 weeks, 4 month post
Baseline child physical activity and change in activity
Time frame: baseline, 8 weeks, 4-month post
Baseline child BMI percentile and change in BMI
Time frame: baseline, 8 weeks, 4-month post
Baseline parent BMI and change in BMI
Time frame: baseline, 8 weeks, 4-month post
Baseline parent dietary intake and change in intake
Time frame: baseline, 8 weeks, 4-month post
Baseline parent physical activity and change in activity
Time frame: baseline, 8 weeks, 4-month post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
- Background: PubMed 24530488Bean 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melanie K Bean, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle counseling in people with Overweight and Obesity, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of sessions attended (time frame: 8 weeks and 4-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01912989, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2015.