Clinical trial NCT03317587: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Eating Disorder
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2017-10-23
Enrollment: 29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Acceptability of intervention
timeFrame: 8 weeks
measure: Feasibility of the intervention
timeFrame: 8 weeks
Secondary outcomes:
measure: Eating disorder behaviors
timeFrame: Baseline to 14 weeks
measure: Risk for obesity (BMI)
timeFrame: Baseline to 14 weeks
measure: Appearance Ideals
timeFrame: Baseline to14 weeks
measure: Emotion Regulation Difficulties
timeFrame: Baseline to14 weeks
measure: Healthy Eating
timeFrame: Baseline to14 weeks
measure: Physical Activity
timeFrame: Baseline to14 weeks
measure: Thin-ideal internalization
timeFrame: Baseline to14 weeks
measure: Negative Affect
timeFrame: Baseline to14 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Suzanne Mazzeo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.