Phase 2
N=10
A Virtual Support Pilot Program for Weight Loss Surgery Patients
Weight · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT01770366 ↗Enrolled (actual)
10
Serious AEs
—
Results posted
Mar 2015
Primary outcome: Primary: BMI — 35.1; 33.9 kg/m2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Weight and Exercise Lifestyle Support (WELS) (Device); Usual Care (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Baystate Medical Center
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMI |
35.1; 33.9 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT01770366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.