Randomized Trial of an Innovative Smartphone Application for Bariatric Surgery
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Obesity
- Sponsor
- Noom Inc.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change in adherence to dietary recommendations
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Mobile technologies/smartphone applications offer a means to effect behavior change without significant obstacles that typically limit implementation of empirically supported therapies (e.g., in-person sessions); however, rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. As more Americans consider bariatric surgery for the treatment of severe obesity, it is imperative to improve factors influencing suboptimal surgical outcomes (e.g., failure to adhere to diet and exercise recommendations and psychosocial impairment). This study will evaluate the effect of the Noom Coach for Bariatric Health platform in improving standard interventions utilized in bariatric surgery programs.
Detailed Description
Overweight and obesity have reached epidemic proportions in the United States. As few behavioral treatments are effective for weight loss, bariatric surgery is an increasingly important option. Although these procedures are more helpful than psychosocial treatments, post-operative weight losses vary widely, and a notable subset of patients demonstrate suboptimal weight loss or substantial weight regain. Adherence to treatment recommendations is a likely contributor to these variable outcomes. Smartphone applications (apps) designed to augment behavior change or enhance adherence, have expanded exponentially in recent years, and are a potentially useful option to improve outcomes, but rigorous research on apps is limited, and high-quality, adequately powered, randomized controlled trials with large samples are required. This study will test a combined smartphone app and health coaching system to improve adherence and behavioral/psychosocial outcomes for patients receiving bariatric surgery. The aims have not been modified since the original phase 1 and will compare usual pre-operative care and pre-surgical use of Noom Coach for Bariatric Health on post-surgery adherence and psychosocial variables in a larger test (n=200) to explore whether usage of the app is a viable predictor of subsequent post-operative weight trajectories 12 months following surgery. This study will also examine app usage as a viable predictor of subsequent post-operative weight and psychosocial trajectories in the 12 months post-surgery and establish sensitivity and specificity of early optimal response to surgical intervention using weight loss, diet and exercise adherence, and psychosocial adjustment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Enrolled in: (1) the Metabolic, Endocrine, and Minimally Invasive Surgery Division at Mount Sinai and planning to receive a bariatric procedure.
- •Between the ages of 18 and 60 at entry to the study.
- •Speak English.
Exclusion Criteria
- •Clinically significant cognitive limitations (Wechsler Abbreviated Scale of Intelligence IQ Estimate \< 70) or history of developmental disability.
- •History of neurological disorder or injury (e.g., seizure disorder or moderate or severe head injury with \>10 minutes loss of consciousness).
- •Current/lifetime DSM-5 bipolar disorder, schizophrenia, or psychotic disorder.
- •Acute suicide risk.
- •Current DSM-5 alcohol or substance use disorder.
- •Pregnancy.
Outcomes
Primary Outcomes
Change in adherence to dietary recommendations
Time Frame: Baseline, 8 weeks, 3 months, and 12 months
Change in adherence to recommendations provided within pre-bariatric surgery program will be assessed using the ASA-24 interview. The interview is a 24-hr recall of all food and drink consumed. This interview will serve as the basis for measuring the adherence to dietary recommendations.
Anthropometric changes (weight)
Time Frame: Baseline, 8 weeks, 3, 6, and 12 months
To calculate trajectories of BMI, measures of height (inches) and weight (pounds) will be obtained at all in-person visits.
Change in adherence to physical activity recommendations (Activity Tracker)
Time Frame: Baseline, 8 weeks, 3 months, and 12 months
Change in adherence to physical activity recommendations will be measured using information collected from each participants activity tracker (FitBit). The activity tracker records number of steps taken each day and any physical activity performed.
Change in adherence to physical activity recommendations (IPAQ)
Time Frame: Baseline, 8 weeks, 3, 6, 9, and 12 months
Change in adherence to physical activity recommendations will also be measured using self reported physical activity using the International Physical Activity Questionnaire (IPAQ) The IPAQ is a 27- item questionnaire that assesses physical activity over the past week as a part of everyday activity, activity as a part of work, and activity as recreation. Scores include both minutes and days spent doing physical activity with higher scores indicating more time spent doing these activities. The measure can be scored categorically (low, moderate, high) or continuously using a defined scoring protocol.
Anthropometric changes (height)
Time Frame: Baseline, 8 weeks, 3, 6, and 12 months
To calculate trajectories of BMI, measures of height (inches) and weight (pounds) will be obtained at all in-person visits.
Secondary Outcomes
- Short Form-36 Health Survey (SF-36)(Baseline, 8 weeks, 3, 6, 9, and 12 months)
- Eating Disorder Examination Questionnaire (EDE-Q)(Baseline, 8 weeks, 3, 6, 9, and 12 months)
- Depression Anxiety Stress Scales (DASS)(Baseline, 8 weeks, 3, 6, 9, and 12 months)