Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)

Conditions
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Obesity, Eating Disorder

Intervention / Treatment
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* Behavioral: INSPIRE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INSPIRE<br> | Behavioral: INSPIRE<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of intervention | Acceptability of the intervention will be assessed via aggregation of the ordinal-level items on the weekly participation satisfaction surveys. | 8 weeks | 
| Feasibility of the intervention | Feasibility of the intervention will be assessed via aggregation of the ordinal-level items on the weekly therapist feasibility surveys. | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline to 14 weeks | 
| 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. | Baseline to 14 weeks | 
| 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. | Baseline to14 weeks | 
| 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. | Baseline to14 weeks | 
| 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. | Baseline to14 weeks | 
| 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. | Baseline to14 weeks | 
| 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. | Baseline to14 weeks | 
| 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. | Baseline to14 weeks |