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ObesityPhase 1/2NCT00167830

Barriers to Treatment in Obese Adolescents

A Phase 1/2 study testing Motivational Interviewing and Strength and Cardiovascular Conditioning in people with Obesity, 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 purpose of this study is to identify significant racial and ethnical differences in risk factors for development of obesity and weight loss in adolescents in Central Virginia Read more about this study

Who is it for?
Ages 11 to 18 years
Conditions the study is for
Obesity
What is being tested?
Motivational Interviewing and Strength and Cardiovascular Conditioning
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
1 siteUnited States
Study dates
Nov 2003to Dec 2013
Phase
Phase 1/2
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age 11-18
  • Above 95th percentile for weight
  • Reside within 30 miles of program site
  • Ability to comprehend basic instructions
  • Ability to perform basic exercise movements

Who cannot join

  • Having a metabolic disorder that causes weight gain
  • Having a cognitive deficit that impacts learning and comprehension
  • Having a physical defect that prevents exercise

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Understanding The Barriers in Treatment of Obesity in Adolescents 11-18 in Central Virginia

The purpose of this study is to identify significant racial and ethnical differences in risk factors for development of obesity and weight loss in adolescents in Central Virginia

Read the detailed description
  • Participation for 6 months in a program incorporating exercise, nutritional counseling and behavioral support leads to measurable improvements in overall fitness, metabolic indicators and loss of body fat for obese adolescents.
  • Degree of loss of body fat, improved overall fitness and improvements in metabolic indicators can be correlated with the degree of compliance and participation for 6 months in the program.
  • Parental involvement and support can be correlated with the degree of compliance and participation in the program.
  • Socioeconomic factors can be correlated with the degree of compliance and participation in the program.
  • Cultural differences in diet, attitudes toward body shape, and family dynamics can be correlated with success or failure in a weight loss program.
  • Individual differences in self-esteem, self-discipline and feelings of connectedness with family members can be correlated with success or failure in a weight loss program.
Conditions
Obesity
Being tested
Motivational Interviewing, Strength and Cardiovascular Conditioning, Food selection and portion control
Keywords
Pediatric Overweight,, African American;, Adolescent;, Intervention,, Teasing;, Self-esteem, Quality of Life, Metabolic syndrome, Insulin resistance, Diabetes, Nutrition, Motivation, Culture, BMI, Cardiorespiratory fitness, Resistance Training, Compliance
Medical subject headings
Obesity, Metabolic Syndrome, Insulin Resistance, Diabetes Mellitus, Patient Compliance

What participants receive

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

  • Motivational InterviewingBehavioural

    Biweekly meetings with a behavior specialist to review subject's progress with the protocol and explore challenges subject is facing in adopting healthy lifestyle behaviors.

  • Strength and Cardiovascular ConditioningBehavioural

    Subjects take part in an exercise program to include 30 minutes of cardiorespiratory exercise at 70% maximum heart rate, and 30 minutes of strength training on Nautilus machines.

  • Food selection and portion controlBehavioural

    Subjects meet on a biweekly basis with a registered dietitian who presents educational information about healthy food selection and portion control.

Study groups in NCT00167830
Study groupRoleWhat they receive
Lifestyle InterventionExperimentalDietary modification and exercise.
Receives: Behavioral: Motivational Interviewing; Behavioral: Strength and Cardiovascular Conditioning; Behavioral: Food selection and portion control

What is being measured

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

  1. A decrease in body mass index.

    Measured: 6 months and 1 year

  2. Improvement in metabolic indicators.

    Measured: 6 months and 1 year

  3. Improvement in fitness measures

    Measured: 6 months and 1 year

Secondary outcomes (7)

  1. Improved subject compliance with exercise and diet.

    Measured: 6 months and 1 year

  2. Improved parental compliance and support.

    Measured: 6 months and 1 year

  3. Increase knowledge of nutritional principles

    Measured: 6 months and 1 year

  4. Improved attitude toward healthy behaviors

    Measured: 6 months and 1 year

  5. Increased self-esteem and motivation

    Measured: 6 months and 1 year

  6. Decreased negativity

    Measured: 6 months and 1 year

  7. Improved family cohesiveness

    Measured: 6 months and 1 year

Timeline

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

  1. First posted14 Sep 2005 (estimated)
  2. Study startNov 2003
  3. Primary completionDec 2013
  4. Study completionDec 2013

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 1/2
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00167830
Sponsor's protocol ID
760
Status last verified
Jan 2014
First submitted
9 Sep 2005
Last updated
20 Jan 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Wickham EP, Stern M, Evans RK, Bryan DL, Moskowitz WB, Clore JN, Laver JH. Prevalence of the metabolic syndrome among obese adolescents enrolled in a multidisciplinary weight management program: clinical correlates and response to treatment. Metab Syndr Relat Disord. 2009 Jun;7(3):179-86. doi: 10.1089/met.2008.0038.

    PubMed 19450141

  • Porter JS, Bean MK, Gerke CK, Stern M. Psychosocial factors and perspectives on weight gain and barriers to weight loss among adolescents enrolled in obesity treatment. J Clin Psychol Med Settings. 2010 Jun;17(2):98-102. doi: 10.1007/s10880-010-9186-3.

    PubMed 20119710

  • Bean MK, Mazzeo SE, Stern M, Evans RK, Bryan D, Ning Y, Wickham EP 3rd, Laver J. Six-month dietary changes in ethnically diverse, obese adolescents participating in a multidisciplinary weight management program. Clin Pediatr (Phila). 2011 May;50(5):408-16. doi: 10.1177/0009922810393497. Epub 2011 Jan 10.

    PubMed 21224253

  • Stern M, Mazzeo SE, Gerke CK, Porter JS, Bean MK, Laver JH. Gender, ethnicity, psychosocial factors, and quality of life among severely overweight, treatment-seeking adolescents. J Pediatr Psychol. 2007 Jan-Feb;32(1):90-4. doi: 10.1093/jpepsy/jsl013. Epub 2006 Jul 3.

    PubMed 16818482

  • Stern M, Mazzeo SE, Porter J, Gerke C, Bryan D,and Laver J. Self-esteem, teasing and quality of life: African American adolescent girls participating in a family-based pediatric overweight intervention. Journal of Clinical Psychology in Medical Settings. DOI:10.1007/s10880-006-9029-4, 2006

  • Browning MG, Bean MK, Wickham EP, Stern M, Evans RK. Cardiometabolic and Fitness Improvements in Obese Girls Who Either Gained or Lost Weight during Treatment. J Pediatr. 2015 Jun;166(6):1364-9. doi: 10.1016/j.jpeds.2015.03.011. Epub 2015 Apr 15.

    PubMed 25890676

  • Ning Y, Yang S, Evans RK, Stern M, Sun S, Francis GL, Wickham EP 3rd. Changes in body anthropometry and composition in obese adolescents in a lifestyle intervention program. Eur J Nutr. 2014 Jun;53(4):1093-102. doi: 10.1007/s00394-013-0612-9. Epub 2013 Nov 10.

    PubMed 24212451

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Motivational Interviewing and Strength and Cardiovascular Conditioning in people with 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 3 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 20 Jan 2014. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

A decrease in body mass index. (time frame: 6 months and 1 year). The study lists 3 primary outcomes in all. 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 NCT00167830, which also lists 7 linked publications.

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 20 Jan 2014.

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