Using the Hunt Motivational Scale to Aid in Weight Loss a... | NCT03530553

Studies
Using the Hunt Motivational Scale to Aid in Weight Loss and Weight Maintenance

NCT03530553

Sponsor

Penn Medicine Princeton Health

Status

Unknown status

Last Update Posted

May 21, 2018Actual

Enrollment

75Estimated

Phase

Not Applicable

Conditions

Weight Loss

Interventions

Hunt Motivational Scale

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 11, 2018Actual

Primary Completion Date

Oct 11, 2018Estimated

Completion Date

Oct 11, 2018Estimated

First Submitted Date

May 8, 2018

First Submission Date that Met QC Criteria

May 8, 2018

First Posted Date

May 21, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 8, 2018

Last Update Posted Date

May 21, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment arm	Experimental	The treatment arm will receive the HMS as well as standard of care of the weight management program.	Other: Hunt Motivational Scale
Control arm	No Intervention	The control arm will not receive the HMS and will receive standard of care.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hunt Motivational Scale	Other	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.

Measure	Description	Time Frame
Weight loss		Six months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient in weight management program at Penn Medicine Princeton Health

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rameck Hunt, MD	Contact	908-930-8257		rahunt@princetonhcs.org

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Penn Medicine Princeton Health	Recruiting	Plainsboro	New Jersey	08536	United States

Condition Browse Module

MeSH Terms

ID	Term
D015431	Weight Loss

Ancestor Terms

ID	Term
D001836	Body Weight Changes
D001835	Body Weight
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

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