Weight LossNCT03530553
Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance
A study testing Hunt Motivational Scale in people with Weight Loss, run by Penn Medicine Princeton Health at 1 site in United States.
Trial summary
In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight management program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Weight Loss
- What is being tested?
- Hunt Motivational Scale
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2018to 11 Oct 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patient in weight management program at Penn Medicine Princeton Health
Who cannot join
- does not have a visit every three to four weeks
- not in active weight loss phase of the program
- diminished intellectual capacity to complete questionnaire i.e. Down's syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Penn Medicine Princeton Health
Plainsboro, New Jersey, 08536
Missy Trammel, 609-853-7220, mtrammel@princetonhcs.org
About this study
In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight management program.
Read the detailed description
Obesity is rising at alarming rates, currently at nearly 40%. There are very few tools, specifically questionnaires, for healthcare providers to help their patients lose weight or maintain their weight loss. The Hunt Motivational Scale is one such tool to help patients identify areas that need improvement in order to aid in weight loss and weight maintenance. The HMS is designed to motivate patients to track, plan, and practice other healthy weight loss and weight maintenance practices so that they will have success.
In this study, approximately 75 subjects in the Penn Medicine Princeton Health weight management program will be randomly assigned to either receive the HMS or not (standard of care). They will be followed for a period of six months at the end of which it will be determined whether the group that received the HMS lost more weight than the control group.
- Conditions
- Weight Loss
- Being tested
- Hunt Motivational Scale
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hunt Motivational ScaleOther
The Hunt Motivational Scale is a tool to help facilitate weight loss and motivate patients to track, plan, and practice healthy weight loss and weight maintenance practices.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | The treatment arm will receive the HMS as well as standard of care of the weight management program. Receives: Other: Hunt Motivational Scale |
| Control arm | No intervention | The control arm will not receive the HMS and will receive standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start11 Apr 2018
- Primary completion11 Oct 2018 (estimated)
- Study completion11 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- There are two arms in this study. One group will receive the HMS and the other will not and will receive standard of care.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Penn Medicine Princeton Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03530553
- Sponsor's protocol ID
- BN 2337
- Status last verified
- May 2018
- First submitted
- 8 May 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance
- ClinicalTrials.gov ID
- NCT03530553
- Acronym / sponsor ID
- BN 2337
- Conditions
- Weight Loss
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Penn Medicine Princeton HealthUniversity, hospital or other
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 11 Oct 2018 (estimated)
- Study completion
- 11 Oct 2018 (estimated)
- First posted
- 21 May 2018 (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.
In this study, we plan to determine the efficacy of the Hunt Motivational Scale as a tool for weight loss compared to standard of care in the Penn Medicine Princeton Health weight management program.
Detailed description
Obesity is rising at alarming rates, currently at nearly 40%. There are very few tools, specifically questionnaires, for healthcare providers to help their patients lose weight or maintain their weight loss. The Hunt Motivational Scale is one such tool to help patients identify areas that need improvement in order to aid in weight loss and weight maintenance. The HMS is designed to motivate patients to track, plan, and practice other healthy weight loss and weight maintenance practices so that they will have success.
In this study, approximately 75 subjects in the Penn Medicine Princeton Health weight management program will be randomly assigned to either receive the HMS or not (standard of care). They will be followed for a period of six months at the end of which it will be determined whether the group that received the HMS lost more weight than the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There are two arms in this study. One group will receive the HMS and the other will not and will receive standard of care.
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Other: Hunt Motivational ScaleThe treatment arm will receive the HMS as well as standard of care of the weight management program. |
| Control arm | No intervention | –The control arm will not receive the HMS and will receive standard of care. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patient in weight management program at Penn Medicine Princeton Health
Key exclusion criteria (3 listed)
- does not have a visit every three to four weeks
- not in active weight loss phase of the program
- diminished intellectual capacity to complete questionnaire i.e. Down's syndrome
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 |
|---|---|---|
| Hunt Motivational ScaleThe Hunt Motivational Scale is a tool to help facilitate weight loss and motivate patients to track, plan, and practice healthy weight loss and weight maintenance practices. | Other | Treatment arm |
Primary outcome
Weight loss
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hunt Motivational Scale in people with Weight Loss, run by Penn Medicine Princeton Health 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: status not confirmed, as of the sponsor's last update on 21 May 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rameck Hunt, MD (908-930-8257, rahunt@princetonhcs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2018.