Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
Primary Purpose
Obesity, Eating Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
INSPIRE
Sponsored by
About this trial
This is an interventional prevention trial for Obesity
Eligibility Criteria
Inclusion Criteria:
- Currently enrolled in postsecondary education at Virginia Commonwealth University
Exclusion Criteria:
- BMI ≥ 30 kg/m2
- Meet criteria for eating disorder threshold risk
- Pregnancy
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
INSPIRE
Arm Description
Outcomes
Primary Outcome Measures
Acceptability of intervention
Acceptability of the intervention will be assessed via aggregation of the ordinal-level items on the weekly participation satisfaction surveys.
Feasibility of the intervention
Feasibility of the intervention will be assessed via aggregation of the ordinal-level items on the weekly therapist feasibility surveys.
Secondary Outcome Measures
Eating disorder behaviors
Change in disordered eating behaviors will be assessed with the Eating Disorder Examination Questionnaire. Participants will complete this one week before the program, one week after the program, and one month after the program.
Risk for obesity (BMI)
Weight will be measured (by trained staff) to the nearest ¼ kg using a digital scale and height will be measured to the nearest cm using a stadiometer; these measurements will be used to calculate BMI (kg/m2). Measurements will be taken one week before the program, one week after the program, and one month after the program.
Appearance Ideals
Changes in appearance ideals will be evaluated with the Body Image-Ideals Questionnaire, a self-report questionnaire that quantifies an individual's perceived discrepancy from and importance of internalized ideals for multiple physical attributes. Participants will complete this one week before the program, one week after the program, and one month after the program.
Emotion Regulation Difficulties
Changes in difficulty regulating emotions and tolerating distress will be assessed with the Difficulties in Emotion Regulation Scale. Participants will complete this one week before the program, one week after the program, and one month after the program.
Healthy Eating
Change in dietary intake will be assessed using the Block Food Screener, a self-report questionnaire that surveys the leading sources of fat, fiber, fruits, and vegetables in the diets of North Americans. Participants will complete this one week before the program, one week after the program, and one month after the program.
Physical Activity
Change in physical activity during the past seven days will be assessed with the Seven-Day Physical Activity Recall. This measures the frequency and duration of each physical activity performed throughout the day. Participants will complete this one week before the program, one week after the program, and one month after the program.
Thin-ideal internalization
Change in thin-ideal internalization will be assessed with the Ideal-Body Stereotype Scale - Revised. Participants will complete this one week before the program, one week after the program, and one month after the program.
Negative Affect
Change in negative affect will be assessed using the sadness, guilt, hostility, and fear/anxiety subscales of the Positive and Negative Affect Scale - Revised. Participants will complete the this one week before the program, one week after the program, and one month after the program.
Full Information
NCT ID
NCT03317587
First Posted
September 27, 2017
Last Updated
December 20, 2017
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT03317587
Brief Title
Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
Official Title
Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
September 5, 2017 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aims of the current study are: 1) to pilot a manualized intervention (INSPIRE - Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise) to determine feasibility and acceptability, and 2) to evaluate the preliminary effectiveness of INSPIRE on physical and psychological variables.
Detailed Description
The purpose of the current study is to implement an evidence-based prevention program to promote positive health behaviors among young adult women. It will be one of the first to intentionally execute a prevention program targeting well-established risk factors for both obesity and eating disorders in this high-risk population. Intervention content focuses on promoting body size diversity and emphasizing positive health and behavior change in order to reduce stigmatization and remain sensitive to weight-related issues. The manual was developed by integrating two successful existing prevention programs and expanding on previous prevention efforts. Specifically, the diversity of beauty ideals were highlighted to enhance relevance among ethnic minority women, and distress tolerance and emotion regulation skills training were included to target the maladaptive coping mechanisms young adults use to manage the stress associated with transitioning to college.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Eating Disorder
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
INSPIRE
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
INSPIRE
Intervention Description
Eight week program of weekly group sessions with homework assignments addressing beauty ideals, establishing a healthy relationship with food and exercise, and tolerating and managing uncomfortable emotions. Participants will complete questionnaires are separate time points (one week before the program, one week after the program, and 1 month after the program) to evaluate the impact of the program on various behavioral and psychological outcomes.
Primary Outcome Measure Information:
Title
Acceptability of intervention
Description
Acceptability of the intervention will be assessed via aggregation of the ordinal-level items on the weekly participation satisfaction surveys.
Time Frame
8 weeks
Title
Feasibility of the intervention
Description
Feasibility of the intervention will be assessed via aggregation of the ordinal-level items on the weekly therapist feasibility surveys.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Eating disorder behaviors
Description
Change in disordered eating behaviors will be assessed with the Eating Disorder Examination Questionnaire. Participants will complete this one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to 14 weeks
Title
Risk for obesity (BMI)
Description
Weight will be measured (by trained staff) to the nearest ¼ kg using a digital scale and height will be measured to the nearest cm using a stadiometer; these measurements will be used to calculate BMI (kg/m2). Measurements will be taken one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to 14 weeks
Title
Appearance Ideals
Description
Changes in appearance ideals will be evaluated with the Body Image-Ideals Questionnaire, a self-report questionnaire that quantifies an individual's perceived discrepancy from and importance of internalized ideals for multiple physical attributes. Participants will complete this one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to14 weeks
Title
Emotion Regulation Difficulties
Description
Changes in difficulty regulating emotions and tolerating distress will be assessed with the Difficulties in Emotion Regulation Scale. Participants will complete this one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to14 weeks
Title
Healthy Eating
Description
Change in dietary intake will be assessed using the Block Food Screener, a self-report questionnaire that surveys the leading sources of fat, fiber, fruits, and vegetables in the diets of North Americans. Participants will complete this one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to14 weeks
Title
Physical Activity
Description
Change in physical activity during the past seven days will be assessed with the Seven-Day Physical Activity Recall. This measures the frequency and duration of each physical activity performed throughout the day. Participants will complete this one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to14 weeks
Title
Thin-ideal internalization
Description
Change in thin-ideal internalization will be assessed with the Ideal-Body Stereotype Scale - Revised. Participants will complete this one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to14 weeks
Title
Negative Affect
Description
Change in negative affect will be assessed using the sadness, guilt, hostility, and fear/anxiety subscales of the Positive and Negative Affect Scale - Revised. Participants will complete the this one week before the program, one week after the program, and one month after the program.
Time Frame
Baseline to14 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Currently enrolled in postsecondary education at Virginia Commonwealth University
Exclusion Criteria:
BMI ≥ 30 kg/m2
Meet criteria for eating disorder threshold risk
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Mazzeo, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
30982943
Citation
Simpson CC, Burnette CB, Mazzeo SE. Integrating eating disorder and weight gain prevention: a pilot and feasibility trial of INSPIRE. Eat Weight Disord. 2020 Jun;25(3):761-775. doi: 10.1007/s40519-019-00685-w. Epub 2019 Apr 15.
Results Reference
derived
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Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
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