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ObesityNCT00433680

Targeted Obesity Prevention Program for Adolescent Females

A study testing Healthy Weight in people with Obesity, run by Oregon Research Institute 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 evaluate the effectiveness of an obesity prevention program when administered to female college freshmen. Read more about this study

Who is it for?
Ages 17 to 19 years, women only
Conditions the study is for
Obesity
What is being tested?
Healthy Weight
How many people
405 participants
Where
1 siteUnited States
Study dates
Mar 2007to Mar 2012
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 17 to 19 years
  • Women only
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • All female college freshmen at the University of Oregon will be invited to participate in the study.

Who cannot join

  • Any participant that meets criteria for an eating disorder at any assessment point will be excluded from the study.
  • Any participant with BMI below 5% for their age group will be excluded to avoid health risks
  • Any participant who does not report some form of body dissatisfaction will be excluded from the study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Oregon Research Institute

    Eugene, Oregon, 97403

Other trials in United States

About this study

The purpose of this study is to evaluate the effectiveness of an obesity prevention program when administered to female college freshmen.

Read the detailed description

The goal of this project is to conduct a large randomized controlled trial of a selected obesity prevention program that reduced risk for future onset of obesity over a 2-year follow-up and decreased bulimic symptoms and negative affect in a preliminary trial (N = 188). The Healthy Weight program targets female adolescents with body image concerns because they are a group at high risk for obesity onset. We propose to focus on body-dissatisfied females during the first year of college because this is a particularly high-risk developmental period for weight gain (Butler, Black, Blue, \& Gretbeck, 2004; Hovell, Mewborn, Randle, \& Fowler-Johnson, 1985). This intervention utilizes persuasion principles from social and clinical psychology (e.g., strategic self-presentation, motivational interviewing) to increase the likelihood that participants will make behavioral changes. This study consists of two components:

We plan to include 405 female college freshmen (aged 17-19) as participants in this study. All first-year female University of Oregon students are mailed a letter of invitation to participate. Posters and flyers on campus are also used as recruitment tools. Participants are assigned to either a healthy weight management condition or a media literacy condition (in which participants learn tricks media use to enhance women's appearance). In both conditions, participants attend four weekly 1-hour sessions led by female research assistants from the Oregon Research Institute. All participants complete 5 structured psychiatric interviews assessing current Diagnostic and Statistical Manual (DSM-IV) symptoms of anorexia nervosa, bulimia nervosa, and binge eating disorder, as well as psychiatric conditions that commonly co-occur with bulimia nervosa during adolescence. Participants also complete 5 surveys that focus on her attitudes, feelings, and behaviors over the past month. Surveys and interviews are administered by trained assessors at baseline, one month later, 6 months from baseline, 12 months from baseline, and 24 months from baseline. Participants' height and weight are also measured during these assessments. If a participant meets criteria for an eating disorder at any assessment point, she is told in a clinically sensitive fashion that a more intensive intervention is needed and treatment referrals are provided. If a participant meets criteria for a co-morbid condition, she is informed of the need to seek treatment, but she is allowed in the study. If a participant is already very thin (in the lowest 5th percentile weight for her height), she is told that it may be dangerous to participate in an intervention that might result in further weight loss, and she will not be allowed in the study. Participants are paid for completing the assessments ($30 for completing each survey and interview, with a $30 bonus for completing all assessments, for a total of $180 over the course of two years). Participants randomly selected to participate in the Validity Sub-study (described below) have the opportunity to earn an additional $180. Identifying information never appears on any interviews or surveys. Identifying information will be collected on separate forms for tracking purposes only. Interviews, surveys, and identifying information forms are transported immediately to Oregon Research Institute by trained assessors.

We will conduct an intensive validation substudy with a randomly selected 15% of participants (n = 60). We plan to assess the validity of self-reported caloric intake with doubly labeled water, and the validity of self-reported activity levels with tri-axial accelerometers. We will also measure resting metabolic rate using a ventilated hood. For each of the 2 academic quarters that we recruit participants during each of the 3 proposed recruitment years, 10 participants will be randomly selected to provide intensive data during the last 2 weeks of the interventions because this should be the period during which there is maximal difference between participants in the two conditions in terms of caloric intake and physical activity. Participants in the validity sub-study will complete all assessments in the University of Oregon's human physiology lab. Assessments will be carried out by trained human physiology staff. Participants will complete pregnancy tests prior to participating in the validity substudy. Pregnant participants will not be able to complete the validity substudy as an extra precaution against any risk to the fetus that may be posed by the doubly labeled water procedure. No risks to fetuses or pregnant women from doubly labeled water have been identified at this point in time. Participants in this substudy will complete a 4-hour assessment within 2 days after the second intervention session (week 2) and will complete another 2-hour assessment within 2 days after the fourth intervention session. Participants will be offered an additional $80 for coming to the lab for the first 4-hour assessment and $100 for coming to the lab for the second 2-hour assessment.

Conditions
Obesity
Being tested
Healthy Weight
Keywords
adolescent, female, obesity, body dissatisfaction
Medical subject headings
Obesity

What participants receive

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

  • Healthy WeightBehavioural

    Also called Healthy Weight Project

    4 weekly 1 hour meetings that encourage reductions in fat and sugar intake and increases in physical activity to decrease onset of obesity and body dissatisfaction.

What is being measured

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

  1. risk for future onset of obesity and weight gain

    Measured: 2 years

Secondary outcomes (1)
  1. measure changes in caloric intake, physical activity, and body dissatisfaction

    Measured: 2 years

Timeline

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

  1. First posted12 Feb 2007 (estimated)
  2. Study startMar 2007
  3. Primary completionMar 2012
  4. Study completionMar 2012

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
405 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00433680
Sponsor's protocol ID
DK72932
Other IDs
R01DK072932
Status last verified
Apr 2014
First submitted
9 Feb 2007
Last updated
8 Apr 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Stice E, Sysko R, Roberto CA, Allison S. Are dietary restraint scales valid measures of dietary restriction? Additional objective behavioral and biological data suggest not. Appetite. 2010 Apr;54(2):331-9. doi: 10.1016/j.appet.2009.12.009. Epub 2009 Dec 16.

    PubMed 20006662
  • Rohde P, Arigo D, Shaw H, Stice E. Relation of self-weighing to future weight gain and onset of disordered eating symptoms. J Consult Clin Psychol. 2018 Aug;86(8):677-687. doi: 10.1037/ccp0000325.

    PubMed 30035584
  • Stice E, Palmrose CA, Burger KS. Elevated BMI and Male Sex Are Associated with Greater Underreporting of Caloric Intake as Assessed by Doubly Labeled Water. J Nutr. 2015 Oct;145(10):2412-8. doi: 10.3945/jn.115.216366. Epub 2015 Sep 2.

    PubMed 26338886
  • Stice E, Durant S. Elevated objectively measured but not self-reported energy intake predicts future weight gain in adolescents. Appetite. 2014 Oct;81:84-8. doi: 10.1016/j.appet.2014.06.012. Epub 2014 Jun 12.

    PubMed 24930597
  • Stice E, Durant S, Burger KS, Schoeller DA. Weight suppression and risk of future increases in body mass: effects of suppressed resting metabolic rate and energy expenditure. Am J Clin Nutr. 2011 Jul;94(1):7-11. doi: 10.3945/ajcn.110.010025. Epub 2011 Apr 27.

    PubMed 21525201

Questions about this trial

What is this clinical trial studying?

A study testing Healthy Weight in people with Obesity, run by Oregon Research Institute 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 1 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 8 Apr 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.

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?

risk for future onset of obesity and weight gain (time frame: 2 years). 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 NCT00433680, which also lists 5 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 8 Apr 2014.

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