Overweight and ObesityHWLNCT03439579
Pilot Study of the HWL Program
A study testing Home weight loss program in people with Overweight and Obesity, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Home weight loss program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2018to 21 Sep 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
Read the 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
- Conditions
- Overweight and Obesity
- Being tested
- Home weight loss program
- Keywords
- Telehealth, Remote weight loss, Self-monitoring, Diet, Physical activity
- Medical subject headings
- Overweight, Obesity, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home weight loss programBehavioural
Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.
| Study group | Role | What they receive |
|---|---|---|
| Home weight loss program | Experimental | 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). Receives: Behavioral: Home weight loss program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight change
body weight change (kg) from pre-to post
Measured: 12 weeks
Secondary outcomes (8)
changes in body weight as a percentage of start weight
percent body weight change
Measured: 12 weeks
changes in body mass index
weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)
Measured: 12 weeks
program satisfaction
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.
Measured: 12 weeks
changes in body fat percentage
changes in body fat percentage
Measured: 12 weeks
changes in waist and hip measurements
changes in waist and hip measurements
Measured: 12 weeks
usability of program components
examine usage of tracking components including step, exercise, diet, and weight tracking
Measured: 12 weeks
changes in eating behavior scores
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.
Measured: 12 weeks
changes in scores on the power of food scale
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2018
- Study start6 Feb 2018
- Primary completion3 Jul 2018
- Study completion21 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Single group pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- South Carolina Telehealth Alliance
- Responsible party
- Principal investigator, Patrick O'Neil, Medical University of South Carolina
- Investigators
- Patrick M O'Neil, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03439579
- Sponsor's protocol ID
- Pro00070941
- Acronym
- HWL
- Status last verified
- Nov 2018
- First submitted
- 7 Feb 2018
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual data is planned to be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Home Weight Loss Program
- ClinicalTrials.gov ID
- NCT03439579
- Acronym / sponsor ID
- HWL / Pro00070941
- Conditions
- Overweight and Obesity
- Keywords
- Telehealth, Remote weight loss, Self-monitoring, Diet, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- South Carolina Telehealth Alliance
- Study start
- 6 Feb 2018 (actual)
- Primary completion
- 3 Jul 2018 (actual)
- Study completion
- 21 Sep 2018 (actual)
- First posted
- 20 Feb 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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group pilot study
| Arm | Type | Receives |
|---|---|---|
| Home weight loss program | Experimental | Behavioral: Home weight loss programParticipants 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- aged 18-70 years
- BMI = 25.0- 40 kg/m2
- Internet access via desktop or laptop computer
- valid email address
- smart phone ownership
Key exclusion criteria (12 listed)
- 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),
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 |
|---|---|---|
| Home weight loss programPatient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data. | Behavioural | Home weight loss program |
Primary outcome
Body weight change
Time frame: 12 weeks
body weight change (kg) from pre-to post
8 secondary outcomes
changes in body weight as a percentage of start weight
Time frame: 12 weeks
changes in body mass index
Time frame: 12 weeks
program satisfaction
Time frame: 12 weeks
changes in body fat percentage
Time frame: 12 weeks
changes in waist and hip measurements
Time frame: 12 weeks
usability of program components
Time frame: 12 weeks
changes in eating behavior scores
Time frame: 12 weeks
changes in scores on the power of food scale
Time frame: 12 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 9 Nov 2018.
- Individual participant dataSharing planned: No. No individual data is planned to be shared with other researchers.
Related trials for Overweight and Obesity
Active, not recruiting
Effect of the Thrive AI Health App on Lifestyle Behaviors and Quality of Life
Diabetes Type 2, Overweight or Obesity
RecruitingObservational study
AI-Driven Metabolic Cohort in Overweight/Obese Chinese Adults
Overweight and Obesity, Diabetes Mellitus, Type 2
RecruitingPhase 2
Safety and Efficacy of ABBV-295 in Adults With Obesity or Overweight With Weight-Related Comorbidities
Obesity, Overweight
Not yet recruiting
SHIFT-TB: Nutrition Intervention and Evaluation
Underweight, Overweight and Obesity
Not yet recruiting
Mazdutide for Reducing Atrial Fibrillation Recurrence After Catheter Ablation in Obese Patients
Atrial Fibrillation (AF), Ablation Treatment
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.
Patrick M O'Neil, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home weight loss program in people with Overweight and Obesity, run by Medical University of South Carolina 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 6 inclusion and 12 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 9 Nov 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?
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?
Body weight change (time frame: 12 weeks). 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 9 Nov 2018; AzTrials last refreshed its copy on 28 Oct 2026.