Obesity Clinical Trial
Official title:
Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
Verified date | December 2017 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | December 8, 2017 |
Est. primary completion date | December 8, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 25 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | Risk for obesity (BMI) | Weight will be measured (by trained staff) to the nearest ΒΌ 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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