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Completed

NCT Number: NCT03439579

Pilot Study of the HWL 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.

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Key information

Conditions

Overweight and Obesity Behavior Body Weight Motor Activity Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home weight loss program

Behavioral

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

Primary outcomes

  1. Body weight change

    Time frame: 12 weeks

    body weight change (kg) from pre-to post

Secondary outcomes

  1. changes in body weight as a percentage of start weight

    Time frame: 12 weeks

    percent body weight change

  2. changes in body mass index

    Time frame: 12 weeks

    weight in kgs divided by height in meters squared to obtain BMI (kg/m^2)

  3. 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.

  4. changes in body fat percentage

    Time frame: 12 weeks

    changes in body fat percentage

  5. changes in waist and hip measurements

    Time frame: 12 weeks

    changes in waist and hip measurements

  6. usability of program components

    Time frame: 12 weeks

    examine usage of tracking components including step, exercise, diet, and weight tracking

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • South Carolina Telehealth Alliance

Registry information

Official study title

Pilot Study of the Home Weight Loss Program

Acronym: HWL

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 20, 2018
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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