A Virtual Support Pilot Program for Weight Loss Surgery Patients

NCT01770366 | Completed Phase 1 Results

• 1 other identifier: BH-12-180
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity affects over one-third of the US population, and is associated with serious medical problems like diabetes and heart disease. Weight loss surgery is the most effective treatment for obesity, but some weight loss surgery patients lose less weight than others, and some patients regain the weight they lost. Researchers have found that support groups help post-surgical patients lose more weight, but long-term support programs often aren't available or are difficult for patients to get to. Physical activity is also important for weight loss surgery patients, but most post-surgical support programs don't focus on helping patients exercise. Our pilot study will test an Internet-based weight loss surgery support program that patients can use from home, and will include new devices such as wireless weight scales and wireless pedometers to help patients track their weight loss and physical activity and share their progress with their clinicians over the Internet. If successful, our support intervention will help more patients successfully lose weight after surgery, and therefore will improve their long-term health.

Conditions

Weight; Physical Activity

Keywords

obesity; weight loss surgery; virtual support; wireless devices; Internet

Outcome Measures

Primary Outcomes (1)

• BMI

  3 months post surgery

Study Arms (2)

Usual Care

PLACEBO COMPARATOR

Patients will receive usual care from the post-surgical clinic team.

Device: Usual Care

Intervention Condition

EXPERIMENTAL

Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.

Device: Weight and Exercise Lifestyle Support (WELS)

Interventions

Weight and Exercise Lifestyle Support (WELS) DEVICE

Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired.

Also known as: FitLinxx Pebble, FitLinxx ActiScale, FitLinxx ActiHealth website

Intervention Condition

Usual Care DEVICE

Usual Care

Eligibility Criteria

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

You may qualify if:

• Baystate Medical Center Weight Loss Surgery Program patient scheduled to have weight loss surgery during the recruitment period
• ≥18 years old (weight loss surgery patients younger than 18 years of age represent a unique population, such that an intervention geared towards adult patients would not be appropriate for this younger population)
• English-speaking (research staff are English-speaking only, and we do not have funding available to hire interpreters or bilingual staff)

You may not qualify if:

• Anyone judged not medically fit to participate in the study (e.g., severe medical or psychiatric problems), as per the physician's clinical judgment (by direct physician query)
• Patients planning to relocate from the area within the next six months (i.e., during study timeframe)
• Patients currently participating in another research study (due to patient burden and the potential for reduced protocol adherence associated with participation in multiple studies)
• Patients weighing over 420 pounds at baseline (due to the weight range on the wireless weight scale, and to allow for some weight gain between the baseline research visit and the date of surgery)
• Patients who do not have a computer with an internet connection in their home (due to the web-based nature of this virtual support program and the need to have the USB antenna set up in the patient's home to collect weight data)

Sponsors & Collaborators

• Baystate Medical Center: lead

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

MeSH Terms

Conditions

Body Weight; Motor Activity; Obesity

Interventions

Weights and Measures

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Sofija Zagarins
• Organization: Baystate Medical Center

sofija.zagarins@baystatehealth.org

413-794-2876

Study Officials

• Sofija E Zagarins, PhD

  Baystate Health and Tufts University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2013
• First Posted: January 17, 2013
• Study Start: January 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 13, 2015
• Results First Posted: March 13, 2015

Record last verified: 2015-03

Locations

US (1)