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Pediatric ObesityNCT02086851

Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program.

A study testing Lifestyle Intervention and Parent Motivational Interviewing in people with Pediatric Obesity and Impact of Parent Intervention on Adolescent Weight Loss, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle modification program focusing on dietary modification and exercise. Parents will be randomized into control and motivational interviewing-based intervention groups. Read more about this study

Who is it for?
Ages 11 to 16 yearsHealthy volunteers can take part
What is being tested?
Lifestyle Intervention and Parent Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
Sep 2011to 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 11 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Inclusion Criteria: Age 11 - 16; BMI > 85th percentile; one parent or guardian committed to participate in protocol; -

Exclusion Criteria: Previous enrollment in IRB3354, IRB3008 or HM11113; Underlying genetic, neurological, endocrine or metabolic condition that preclude weight loss with conventional diet and exercise programs; Weight greater than 400 pounds, Pregnancy in female subjects; Inability to understand study instructions due to language barrier or mental disability; Primary residence outside a 30 mile radius of study location.

-

Trial locations and contacts

1 site in 1 country.

United States1 site

  • CHoR at VCU Healthy Lifestyles Center

    Henrico, Virginia, 23229

Other trials in United States

About this study

Official title: Impact of a Structured Parent Intervention on Weight Loss and Behavioral Change in Overweight Adolescents Enrolled in a Lifestyle Modification Program

The study will enroll 110 overweight and obese adolescents ages 11-16 in a lifestyle modification program focusing on dietary modification and exercise. Parents will be randomized into control and motivational interviewing-based intervention groups. The primary hypothesis is that adolescents whose parents are in the intervention group will have improved compliance, weight loss and health outcomes compared with adolescents whose parents do not receive the intervention.

Read the detailed description

Adolescents will participate in a 6-month intensive lifestyle modification that includes a structured exercise program, nutrition education and dietary modification and behavioral support, followed by a 6-month maintenance phase with monthly booster sessions. Parents will be randomized to participate in 4 dedicated "pre-treatment" parent psychoeducational sessions vs. control (no psychoeducational sessions). The sessions will explore parents' feelings about participation in a weight management program, explore their reasons for wanting to make behavioral changes, and enhance motivation. All parents will participate in monthly parent support groups while their adolescents are participating in the intervention phase of the study. The 6-month adolescent intervention will include biweekly sessions with a registered dietitian for dietary education; biweekly interactive group discussion sessions on topics pertaining to motivation, strategies for changing health behaviors, setting and keeping goals and dealing with peer pressure; and exercise sessions three times a week with 30 minutes of cardiovascular exercise and 30 minutes of strength training each session. Comprehensive assessments, including nutrition, behavior and exercise assessments, laboratory work, body composition measurements and medical assessments will be conducted at baseline, 6 months and 12 months.

Being tested
Lifestyle Intervention, Parent Motivational Interviewing
Keywords
pediatric obesity, motivational interviewing, lifestyle intervention
Medical subject headings
Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lifestyle InterventionBehavioural

  • Parent Motivational InterviewingBehavioural

Study groups in NCT02086851
Study groupRoleWhat they receive
Lifestyle Intervention plus Parent Motivational InterviewingExperimentalLifestyle intervention + Parent MI
Receives: Behavioral: Lifestyle Intervention; Behavioral: Parent Motivational Interviewing
Lifestyle Intervention aloneActive comparatorlifestyle intervention alone
Receives: Behavioral: Lifestyle Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in BMI z-scores

    Measured: 12 weeks, 6 months and 12 months

Secondary outcomes (11)

  1. Changes in body composition

    Measured: 12 weeks, 6 months and 1 year

  2. Changes in BMI

    Measured: 12 weeks, 6 months and 12 months

  3. Changes in insulin sensitivity

    Measured: 12 weeks, 6 months and 12 months

  4. Changes in blood pressure

    Measured: 12 weeks, 6 months and 12 months

  5. Changes in serum lipids

    Measured: 12 weeks, 6 months and 12 months

  6. Changes in fitness measures

    Measured: 12 weeks, 6 months and 12 months

  7. Changes in ECG parameters

    Measured: 12 weeks and 6 months

  8. Changes I dietary intake

    Measured: 12 weeks, 6 months and 12 months

  9. Changes in quality of life scores

    Measured: 12 weeks, 6 months and 12 months

  10. Changes in BMI of participating parents

    Measured: 12 weeks, 6 months and 12 months

  11. Changes in body composition of participating parents

    Measured: 12 weeks, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2014 (estimated)
  2. Study startSep 2011
  3. Primary completionAug 2015
  4. Study completionAug 2015

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02086851
Sponsor's protocol ID
HM13833
Status last verified
Feb 2016
First submitted
7 Feb 2014
Last updated
11 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Lifestyle Intervention and Parent Motivational Interviewing in people with Pediatric Obesity and Impact of Parent Intervention on Adolescent Weight Loss, 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?

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 11 Feb 2016. 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?

Change in BMI z-scores (time frame: 12 weeks, 6 months and 12 months). 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 NCT02086851.

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 11 Feb 2016.

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