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

Not Applicable

Completed

• Conditions: Obesity; Eating Disorder
• Interventions: Behavioral: INSPIRE

• Registration Number: NCT03317587
• Lead Sponsor: Virginia Commonwealth University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-05
• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-10-20
• Study First Posted: 2017-10-23
• Status Verified: 2017-12
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-08
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

Inclusion Criteria

• Currently enrolled in postsecondary education at Virginia Commonwealth University

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Exclusion Criteria

• BMI ≥ 30 kg/m2
• Meet criteria for eating disorder threshold risk
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INSPIRE	INSPIRE	-

Primary Outcome Measures

Name	Time	Method
Feasibility of the intervention	8 weeks	Feasibility of the intervention will be assessed via aggregation of the ordinal-level items on the weekly therapist feasibility surveys.
Acceptability of intervention	8 weeks	Acceptability of the intervention will be assessed via aggregation of the ordinal-level items on the weekly participation satisfaction surveys.

Secondary Outcome Measures

Name	Time	Method
Healthy Eating	Baseline to14 weeks	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.
Eating disorder behaviors	Baseline to 14 weeks	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)	Baseline to 14 weeks	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	Baseline to14 weeks	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	Baseline to14 weeks	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.
Physical Activity	Baseline to14 weeks	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	Baseline to14 weeks	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	Baseline to14 weeks	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.

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States