Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00433680
Status:
COMPLETED
Last Update Posted:
2014-04-08
First Post:
2007-02-09
Brief Title:
Targeted Obesity Prevention Program for Adolescent Females
Sponsor:
Oregon Research Institute
Organization:
Oregon Research Institute
Study Overview
Official Title:
Targeted Obesity Prevention Program for Adolescent Females
Status:
COMPLETED
Status Verified Date:
2014-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness of an obesity prevention program when administered to female college freshmen
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 eg 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 womens 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 Oregons 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
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 womens 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 Oregons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK072932 | NIH | None | httpsreporternihgovquickSearchR01DK072932 |