ObesityNCT03317587
Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
A study testing INSPIRE in people with Obesity and Eating Disorder, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Eating Disorder
- What is being tested?
- INSPIRE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2017to 8 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Currently enrolled in postsecondary education at Virginia Commonwealth University
Who cannot join
- BMI ≥ 30 kg/m2
- Meet criteria for eating disorder threshold risk
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
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.
Read the 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.
- Conditions
- Obesity, Eating Disorder
- Being tested
- INSPIRE
- Medical subject headings
- Obesity, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INSPIREBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| INSPIRE | Experimental | Not described Receives: Behavioral: INSPIRE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of intervention
Acceptability of the intervention will be assessed via aggregation of the ordinal-level items on the weekly participation satisfaction surveys.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start5 Sep 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzanne Mazzeo, PhD, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03317587
- Sponsor's protocol ID
- HM20011075
- Status last verified
- Dec 2017
- First submitted
- 27 Sep 2017
- Last updated
- 22 Dec 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30982943
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiring Nutritious Selections and Positive Intentions Regarding Eating and Exercise (INSPIRE)
- ClinicalTrials.gov ID
- NCT03317587
- Acronym / sponsor ID
- HM20011075
- Conditions
- Obesity, Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 23 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INSPIRE | Experimental | Behavioral: INSPIRE |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Currently enrolled in postsecondary education at Virginia Commonwealth University
Key exclusion criteria (3 listed)
- BMI ≥ 30 kg/m2
- Meet criteria for eating disorder threshold risk
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| INSPIREEight 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. | Behavioural | INSPIRE |
Primary outcome
Acceptability of intervention
Time frame: 8 weeks
Acceptability of the intervention will be assessed via aggregation of the ordinal-level items on the weekly participation satisfaction surveys.
Feasibility of the intervention
Time frame: 8 weeks
Feasibility of the intervention will be assessed via aggregation of the ordinal-level items on the weekly therapist feasibility surveys.
8 secondary outcomes
Eating disorder behaviors
Time frame: Baseline to 14 weeks
Risk for obesity (BMI)
Time frame: Baseline to 14 weeks
Appearance Ideals
Time frame: Baseline to14 weeks
Emotion Regulation Difficulties
Time frame: Baseline to14 weeks
Healthy Eating
Time frame: Baseline to14 weeks
Physical Activity
Time frame: Baseline to14 weeks
Thin-ideal internalization
Time frame: Baseline to14 weeks
Negative Affect
Time frame: Baseline to14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
- Derived from this study: PubMed 30982943Simpson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne Mazzeo, PhD principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INSPIRE in people with Obesity and Eating Disorder, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of intervention (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03317587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.