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Pilot Study of the HWL Program

Pilot Study of the Home Weight Loss Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03439579
Acronym
HWL
Enrollment
30
Registered
2018-02-20
Start date
2018-02-06
Completion date
2018-09-21
Last updated
2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and Obesity

Keywords

Telehealth, Remote weight loss, Self-monitoring, Diet, Physical activity

Brief 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.

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

Interventions

BEHAVIORALHome weight loss program

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

Sponsors

South Carolina Telehealth Alliance
CollaboratorOTHER
Medical University of South Carolina
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Single group pilot study

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Body weight change12 weeksbody weight change (kg) from pre-to post

Secondary

MeasureTime frameDescription
changes in body mass index12 weeksweight in kgs divided by height in meters squared to obtain BMI (kg/m\^2)
program satisfaction12 weeksprogram 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.
changes in body fat percentage12 weekschanges in body fat percentage
changes in body weight as a percentage of start weight12 weekspercent body weight change
usability of program components12 weeksexamine usage of tracking components including step, exercise, diet, and weight tracking
changes in eating behavior scores12 weeksuse 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.
changes in scores on the power of food scale12 weeksuse 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.
changes in waist and hip measurements12 weekschanges in waist and hip measurements

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026