Pilot Study of the HWL Program

NCT ID: NCT03439579

Last Updated: 2018-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-06

Study Completion Date

2018-09-21

Brief Summary

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The goal of the project is to test a remotely delivered, standalone behavioral weight loss intervention designed to help adults initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss.

Detailed Description

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The Weight Management Center currently offers a remotely delivered (smart phone, tablet, computer) program to assist patients with maintaining weight losses already achieved, which includes multi-channel self-monitoring and asynchronous individually recorded feedback from clinical staff. The goal of the presently proposed project is to build on this existing maintenance-focused program to create a remotely delivered, standalone behavioral weight loss intervention designed to help participants initiate the important dietary, physical activity (PA) and behavioral changes necessary to achieve weight loss. We recently developed the Home Weight Loss (HWL) program by repackaging existing clinical educational materials as instructional lifestyle change modules to be delivered remotely for participant weight loss

The aim of the proposed project are to pilot test the effects of the HWL program among a sample of overweight and obese adults (N=30). The digital platform currently used in the maintenance program will be used for the HWL program

Conditions

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Overweight and Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group pilot study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Home weight loss program

Participants will be instructed to daily monitor their body weight, minutes of activity, number of steps, and calories consumed for the duration of the pilot study, and they will receive recorded individualized feedback on this self-monitored data from Weight Management Center clinicians (registered dietitians, exercise psychologists, and behavioral specialists).

Group Type EXPERIMENTAL

Home weight loss program

Intervention Type BEHAVIORAL

Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.

Interventions

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Home weight loss program

Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* aged 18-70 years
* BMI = 25.0- 40 kg/m2
* Internet access via desktop or laptop computer
* valid email address
* smart phone ownership
* women of childbearing potential must agree to use effective contraception during the study

Exclusion Criteria

* currently dieting (\>10-pound weight loss in past 3 months)
* another member of the household is participating in this pilot study
* inability to engage in physical activity
* inability to read and speak English
* diagnosis of diabetes (other than treated by diet alone),
* uncontrolled thyroid condition or other endocrine disorder
* major depressive disorder or other severe psychiatric disorder (e.g., bipolar disorder) within the past two years
* past suicide attempt
* current use of prescription or over-the-counter weight loss medications
* current/planned pregnancy
* drug and/or alcohol abuse
* use of steroid medication for more than 10 days in the past three months \*implanted electronic devices
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Carolina Telehealth Alliance

OTHER

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Patrick O'Neil

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patrick M O'Neil, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00070941

Identifier Type: -

Identifier Source: org_study_id

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