Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2017
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 5, 2017
CompletedFirst Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 8, 2017
CompletedDecember 22, 2017
December 1, 2017
3 months
September 27, 2017
December 20, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (8)
Eating disorder behaviors
Baseline to 14 weeks
Risk for obesity (BMI)
Baseline to 14 weeks
Appearance Ideals
Baseline to14 weeks
Emotion Regulation Difficulties
Baseline to14 weeks
Healthy Eating
Baseline to14 weeks
- +3 more secondary outcomes
Study Arms (1)
INSPIRE
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- Currently enrolled in postsecondary education at Virginia Commonwealth University
You may not qualify if:
- BMI ≥ 30 kg/m2
- Meet criteria for eating disorder threshold risk
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Related Publications (1)
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.
PMID: 30982943DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne Mazzeo, PhD
Virginia Commonwealth University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 23, 2017
Study Start
September 5, 2017
Primary Completion
December 8, 2017
Study Completion
December 8, 2017
Last Updated
December 22, 2017
Record last verified: 2017-12