Pilot Study of the HWL Program (HWL)

November 8, 2018 updated by: Patrick O'Neil, Medical University of South Carolina

Pilot Study of the Home Weight Loss Program

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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).
Behavioral: Home weight loss program
Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body weight change
Time Frame: 12 weeks
body weight change (kg) from pre-to post
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
changes in body weight as a percentage of start weight
Time Frame: 12 weeks
percent body weight change
12 weeks
changes in body mass index
Time Frame: 12 weeks
weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)
12 weeks
program satisfaction
Time Frame: 12 weeks
program satisfaction obtained from multiple choice items developed by study staff. Subjects are asked to rate their level of agreement with items assessing their satisfaction with the overall program, available responses range from extremely satisfied to not at all satisfied.
12 weeks
changes in body fat percentage
Time Frame: 12 weeks
changes in body fat percentage
12 weeks
changes in waist and hip measurements
Time Frame: 12 weeks
changes in waist and hip measurements
12 weeks
usability of program components
Time Frame: 12 weeks
examine usage of tracking components including step, exercise, diet, and weight tracking
12 weeks
changes in eating behavior scores
Time Frame: 12 weeks
use of the Eating Behavior Inventory (EBI). This is a validated 26-item scale assessing eating and weight control behaviors. Subjects indicate agreement with statements with reponse options ranging in values from 1 (never or hardly ever) to 5 (always or almost). Higher values are indicative of those most associated with weight loss (e.g., self-monitoring caloric intake) and are therefore associated with better weight loss outcomes following behavioral weight management intervention.
12 weeks
changes in scores on the power of food scale
Time Frame: 12 weeks
use of the Power of Food Scale (PFS). This is a validated 15-item scale with responses scored and ranging between 1 (do not agree) and 5 (strongly agree) with the statements. Higher scores indicate less favorable outcomes, as higher scores indicate increased patient susceptibility to food in the environment.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medical University of South Carolina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
South Carolina Telehealth Alliance

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick M O'Neil, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 6, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00070941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

No individual data is planned to be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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