Pilot Study of the HWL Program

NCT03439579 | Completed

• 1 other identifier: Pro00070941
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Body weight change

  body weight change (kg) from pre-to post

  12 weeks

Secondary Outcomes (8)

• changes in body weight as a percentage of start weight

  12 weeks

• changes in body mass index

  12 weeks

• program satisfaction

  12 weeks

• changes in body fat percentage

  12 weeks

• changes in waist and hip measurements

  12 weeks

Study Arms (1)

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).

Behavioral: Home weight loss program

Interventions

Home weight loss program BEHAVIORAL

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

Home weight loss program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead
• South Carolina Telehealth Alliance: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Patrick M O'Neil, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single group pilot study

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 20, 2018
• Study Start: February 6, 2018
• Primary Completion: July 3, 2018
• Study Completion: September 21, 2018
• Last Updated: November 9, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)